No intent to proceed with alloHCT using donor sources not specified in this protocol, including human leukocyte antigen (HLA)-mismatched related or unrelated donors (< 6/6 HLA related matched or < 8/8 HLA unrelated matched) or umbilical cord blood unit(s).
Patient should be human leukocyte antigen (HLA) typed (A, B, C, DR and DQ) during induction therapy phase or a written explanation for not undergoing HLA typing on the flow sheet
Patients must be positive for at least one of the following human leukocyte antigens (HLA): a. HLA-A*02:01, b. HLA-A*02:06, c. HLA-A*24:02
Human leukocyte antigen (HLA) 8/8 or 7/8 matched related or unrelated donor available, as determined by antigen or allele level typing at HLA A, B, C, and allele level typing at major histocompatibility complex, class II, DR beta 1 (HLA DRB1)
Patients with related or unrelated donors for whom the best available donor is: a) mismatched at antigen level for any single class I locus (HLA-A, -B, -C) +/- an additional class I mismatch at the allele level OR mismatched at the allele level for any 2 class I loci (if typed at the molecular level) OR mismatched at the antigen or allele level for class II loci HLA-DRB1 and/or – DQB1; must be matched for at least one DRB1 allele and one DQB1 allele; b) there is a likelihood of rapid disease progression while HLA typing and results of a preliminary search and the donor pool suggests that a 10/10 HLA-A, B, C, DRB1 and DQB1 matched donor will not be found; c) there is no HLA-A, -B or -C one locus allelic mismatched donor available
Patients for whom the best available donor is mismatched at both HLA class I and class II
DONOR: Related or unrelated volunteer donors who are mismatched with the recipient within one of the following limitations:\r\n* Mismatch for one HLA class I antigen with or without an additional mismatch for one HLA-class I allele, but matched for HLA-DRB1 and HLA-DQ, OR\r\n* Mismatched for two HLA class I alleles, but matched for HLA-DRB1 and HLA-DQ, OR\r\n* HLA class I HLA-A, -B, -C allele matched donors allowing for any one or two DRB1 and/or DQB1 antigen allele mismatch
DONOR: HLA-matching must be based on results of high resolution typing at HLA-A, –B, -C, -DRB1, and –DQB
Availability of appropriate HLA partially-matched and restricted tabelecleucel cell product
Subject is HLA-A*02:01, HLA-A*02:05, and/or HLA-A*02:06 positive as determined by a central laboratory. (This determination will be made under a pre enrollment screening informed consent form [ICF]. There are no restrictions on the timing of HLA typing for screening and data can be taken from subjects' records).
Absence of donor specific HLA antibodies
The HLA-matched donor must be medically fit to donate and willing to donate bone marrow.
HLA typing prior to referral (consultation with HCT physician). If a subject has had HLA typing with accompanying documentation that full siblings were not HLA typed and that a search of the unrelated donor registry was not performed the subject will be considered eligible. Documentation will be reviewed and adjudicated by the Protocol Officer or his/her designee.
The donor and recipient must have an HLA-8/8 allelic match at the HLA-A, -B, -C, and - DRB1 loci. High-resolution typing is required for all alleles. Only matched unrelated donors are acceptable for this trial.
HLA-mismatch at the HLA-A, -B, -C, and - DRB1 loci. Note, HLA-DQ mismatches are permissible
DONOR: HLA mismatched or haploidentical related donors (including 1st degree relatives and half siblings)\r\n* The donor and recipient must be identical at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1; a minimum match of 5/10 is therefore required, and will be considered sufficient evidence that the donor and recipient share one HLA haplotype
DONOR: Matched unrelated donors\r\n* Unrelated volunteer donor matched for HLA-A, -B, -C and -DRB1 defined by high resolution molecular typing\r\n** Mismatched unrelated volunteer donors may be considered if no other suitable donor is available
DONOR: HLA-identical sibling
DONOR: Sibling of any patient enrolled on this protocol proven by ABO typing, human leukocyte antigen (HLA) typing and variable number tandem repeat (VNTR) analysis to be syngeneic with the patient (e.g. identical twin)
Patients with pre-existing medical conditions or other factors that renders them at high risk for regimen related toxicity or ineligible for conventional myeloablative HCT and who do not have HLA-matched related or unrelated donors
Patients with a related donor who is identical for one HLA haplotype
DONOR: Related donors who are identical for one HLA haplotype
Suitably HLA-matched related or unrelated donors
Any identified and available 10/10 HLA-matched related donor or 10/10 HLA-matched unrelated donor.
Have evidence of recipient donor specific anti-HLA antibodies.
Available mismatched related (mMRD) or mismatched unrelated (mMUD) donor, HLA matched 8/10 or 9/10
HLA-matched related or unrelated donor available
HLA-haploidentical related donor (aged 12 to 70 years)
Patients must have available both: a)One or more potential related mismatched donors (biologic parent(s) or siblings (full or half) or children). At least low resolution DNA based human leukocyte antigen (HLA) typing at HLA-A, -B, and -DRB1 for potential haploidentical sibling donors is required. b)At least two potential umbilical cord blood units identified. Each unit must have a minimum of 1.5 x 10^7/kg pre-cryopreserved total nucleated cell dose. For non-red blood cell depleted units, the minimum pre-cryopreserved total nucleated cell dose of each unit must be at least 2.0 x 10^7/kg. Units must be HLA matched at a minimum of 4/6 to the recipient at HLA-A, HLA-B (at low resolution using DNA based typing) and HLA-DRB1 (at high resolution using DNA based typing). Confirmatory typing is not required for randomization.
Additional Patient Inclusion Criteria for Patients Assigned to Haploidentical BM Arm: Patients must be HLA typed at high resolution using DNA based typing at the following HLA-loci: HLA-A, -B, -C and DRB1 and have available a related haploidentical BM donor with 2, 3, or 4 HLA-mismatches. A unidirectional mismatch in either the graft versus host or host versus graft direction is considered a mismatch. The donor and recipient must be HLA identical for at least one antigen (using high resolution DNA based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C, and HLA-DRB1. Fulfillment of this criterion shall be considered sufficient evidence that the donor and recipient share one HLA haplotype, and typing of additional family members is not required.
Units must be HLA matched at a minimum of 4/6 to the recipient at HLA -A, HLA-B (at low resolution using DNA based typing), and HLA -DRB1 (at high resolution using DNA based typing).
A sibling donor who is a 6/6 match at HLA-A and -B (intermediate or higher resolution) and -DRB1 (at high resolution using DNA-based typing) and must be willing to donate peripheral blood stem cells and meet institutional criteria for donation OR
A related donor (other than sibling) who is a 8/8 match for HLA-A, -B, -C (at intermediate or higher resolution) and -DRB1 (at high resolution using DNA-based typing) and must be willing to donate peripheral blood stem cells and meet institutional criteria for donation OR
An unrelated donor who is an 8/8 match at HLA-A, -B, -C, and -DRB1 (at high resolution using DNA-based typing) and must be willing to donate peripheral blood stem cells and meet institutional criteria for donation.
The patient must test positive for HLA-A2 (tested by a CLIA approved laboratory; only the\r\n HLA A*02:01 subtype is eligible)
Subject is HLA-A*02:01 and/or HLA-A*02:06 positive.
Subject is HLA-A*02:05 in either allele, HLA-B*15:01 and/or HLA-B*46:01 positive. Subject has any A*02 null allele (designated with an \N\, e.g. A*02:32N) as the sole HLA-A*02 allele.
Patients must be positive for HLA-A2 based on flow­cytometry or genotyping
No suitable fully matched related (6/6 match for human leukocyte antigen (HLA)-A and B at intermediate or high resolution and DRB1 at high resolution using DNA-based typing) or unrelated donor (8/8 match for HLA-A, B, C, and DRB1 at high resolution using DNA-based typing) available. Search for an unrelated donor and enrollment on this protocol may be abandoned if the clinical situation dictates an urgent transplant in the best medical judgment of the treating provider. The definition of clinical urgency may include a low likelihood of identifying a suitable matched unrelated donor within 6-8 weeks from referral and the medical need to choose a donor without further delay beyond that time.
HLA haplo first degree relatives of the patient including biological parents, siblings or half siblings, or children with 2, 3, or 4 mismatches using DNA-based typing. A unidirectional mismatch in either the graft versus host or host versus graft direction is considered a mismatch. The donor and recipient must be identical at a minimum of one allele (at high resolution DNA-based typing) at the following genetic loci: HLA-A, -B, -C, and DRB1.
Presence of anti-donor HLA antibodies (positive anti-donor HLA antibody is defined as a positive cross-match test of any titer by complement-dependent cytotoxicity or flow cytometric testing or the presence of anti-donor HLA antibody to the high expression loci HLA-A, B, C, DRB1, or DPB1 with mean fluorescence intensity (MFI) > 1000 by solid phase immunoassay).
Recipient of 9/10 or 10/10 (human leukocyte antigen [HLA]-A, -B, -C, -DRB1, -DQB1) matched bone marrow allogeneic hematopoietic stem cell transplantation (HSCT) OR 4/6, 5/6, and 6/6 (HLA-A, -B, -DR) matched cord blood allogeneic HSCT
Availability of at least one 9-10/10 human leukocyte antigen (HLA)-matched related (excluding an identical twin) or unrelated donor, or an HLA-haploidentical related donor
DONOR: Related donors with at least a haplotype at HLA-A, B, C, DR, and DQ loci that is shared with the recipient by high resolution typing, excluding an identical twin or unrelated donors matched 9-10/10 at HLA-A, B, C, DR, and DQ loci by high resolution typing
The patient must have an available sibling or matched unrelated donor with at least a 7/8 human leukocyte antigen (HLA) match
DONOR: HLA genotypically identical sibling matched relative
DONOR: HLA matched unrelated donor according to Standard Practice HLA matching criteria:\r\n* Matched HLA-A, -B, -C, and -DRB1 alleles by high resolution typing\r\n* Only a single allele disparity will be allowed for HLA-A, B, or C as defined by high resolution typing
A minimum genotypic identical match of 4/8 is required, as determined by high resolution typing, at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, and HLA- DRB1.
Patient with a HLA-matched (HLA-A, B, C, and DR beta 1 [DRB1] molecularly matched) unrelated donor or related donor capable of donating PBSC
HLA-matched related donors >= 18 years and capable and willing to donate PBSC (Arms A and B)
HLA-matched unrelated donors (HLA-A, B, C, and DRB1 matched based on high-resolution typing) capable and willing to donate PBSC (Arms C and D)
Any human leukocyte antigen (HLA) type; (historic HLA typing is permitted)
Human leukocyte antigen (HLA)-A1, A2, A3, B35, or B51.
No suitable human leukocyte antigen (HLA)-identical sibling donor
Available HLA 3-5/6 matched genotypically haploidentical family member donor (based upon A, B intermediate and DRB1 high resolution HLA typing; additional C and DQB1 typing may be necessary to accurately assign haplotypes)
Available HLA identical matched sibling donor (unless having failed a prior allogeneic transplant from an HLA identical matched sibling)
Recipient HLA antibodies against donor HLA
DONOR: half match (haploidentical) at HLA-A, B, C, DRB1 based upon deoxyribonucleic acid (DNA) based typing methods; donors may be variably matched for the other allele (4/8 to 7/8), but not fully matched
DONOR: Human leukocyte antigens (HLA)-identical related donors or unrelated donors matched for HLA-A, B, C, DRB1, and DQB1 or mismatched for a single allele at HLA-A, B, C, DRB1 or a single DQB1 antigen or allele mismatch by high resolution deoxyribonucleic acid (DNA) typing
DONOR: HLA-matched sibling bone marrow in combination with HLA-matched sibling umbilical cord blood if the HLA-matched sibling umbilical cord blood was collected and stored; the HLA-matched sibling bone marrow and cord blood would be matched for HLA-A, B, C, DRB1, and DQB1
DONOR: Unrelated Umbilical Cord Blood: Unit selection is based on the cryopreserved total nucleated cell (TNC) dose and matching at HLA-A, B antigen level and DRB1 allele level typing; while HLA-C antigen/allele level typing is not considered in the matching criteria, if available, may be used to optimize unit selection
GRAFT CRITERIA: \r\n* UCB units will be selected according to current umbilical cord blood graft selection algorithm; one or 2 UCB units may be used to achieve the required cell dose\r\n* The UCB graft is matched at 4-6 human leukocyte antigen (HLA)-A, B, DRB1 antigens with the recipient; this may include 0-2 antigen mismatches at the A or B or DRB1 loci; unit selection based on cryopreserved nucleated cell dose and HLA-A,B, DRB1 using intermediate resolution A, B antigen and DRB1 allele typing\r\n* If 2 UCB units are required to reach the target cell dose, each unit must be a 4-6 antigen match to the recipient
TREATMENT WITH SJCAR19: CD19+ ALL with any of the following:\r\n* Primary refractory disease despite at least 2 cycles of an intensive chemotherapy regimen designed to induce remission\r\n* Refractory disease despite salvage therapy\r\n* 2nd or greater relapse\r\n* Any relapse after allogeneic hematopoietic cell transplantation  \r\n* 1st relapse if patient requires an allogeneic HCT as part of standard of care relapse therapy, but is found to be ineligible and/or unsuitable for HCT for any of the following reasons:\r\n* Patients that do not have an available allogeneic donor (defined as at least a 7/8 human leukocyte antigen (HLA)-matched related/unrelated \r\ndonor, 5/6 HLA-matched umbilical cord donor, or 3/6 HLA-matched haploidentical donor)\r\n* Patients with refractory leukemia, for which allogeneic transplant is known to be less effective in the B-ALL population, and\r\n* Patients who are unable to receive myeloablative total body irradiation (TBI), which is included in standard transplant regimens for patients with B-ALL. \r\n**ALL must be confirmed to be CD19+ within 3 months prior to enrollment for treatment
DONOR: Must be a 10/10 human leukocyte antigen (HLA) genotypically match related or unrelated donor at all A, B, C, DRB1, and DQB1 loci, as tested by deoxyribonucleic acid (DNA) analysis.
HSCT Donor will be one of the following:\r\n* 5/6 or 6/6 (human leukocyte antigen [HLA]-A, B, DR) matched related donor\r\n* 7/8 or 8/8 (HLA-A, B, DR, C) matched unrelated donor. Matching in the unrelated setting must be at the allele level\r\n* Haploidentical related donor, defined as ? 3/6 (HLA-A, B, DR) matched\r\n* >= 4/6 (HLA-A, B, DR) umbilical cord blood (UCB). Matching in the UCB setting is at the antigen level. Recipients may receive either one or two UCB units. In the case of 2 UCB units, both units must have been at least 4/6 matched with the recipient
HLA-A*0201 (HLA-A2.1) positivity by molecular subtyping
DONOR: Arm A: All candidates for this study must have a human leukocyte antigen (HLA) (A, B, C, and DR) identical sibling who is willing to donate primed blood stem cells (preferred) or bone marrow, or have a 10/10 (A, B, C, DR and DQ) allele matched unrelated donor; DQ or DP mismatch is allowed per discretion of the principal investigator
DONOR: Arm B: The recipient must have a related donor genotypically HLA-A, B, C and DRB1 loci haploidentical to the recipient; no HLA matched sibling or matched unrelated donor is available; DSA is allowed with desensitization done if recommended by donor selection committee (DSC) per City of Hope (COH) standard operating procedures (SOP)
DONOR: Human leukocyte antigen (HLA) haplo-identical matched related.
All candidates for this study must have a human leukocyte antigen (HLA) (A, B, C, DR) identical sibling who is willing to donate primed blood stem cells (preferred) or bone marrow, or have a 10/10 allele matched unrelated donor; all ABO blood group combinations of the donor/recipient are acceptable
Donor and recipient match each other for at least 7/8 human leukocyte antigen (HLA)-loci (HLA-A, B, C, and D-related [DR]).
2 CB units will be selected according to current Memorial Sloan Kettering Cancer Center (MSKCC) unit selection algorithm. High resolution 8 allele HLA typing and recipient HLA antibody profile will be performed. Unit selection will occur based on HLA-match, total nucleated cell (TNC) and CD34+ cell dose adjusted per patient body weight. The bank of origin will also be taken into account. Donor specific HLA antibodies, if present, will also be taken into consideration and may influence the selection of the graft.\r\n* Each CB unit must be at least 3/8 HLA-matched to the patient considering high-resolution 8-allele HLA typing.\r\n* Each CB unit will be required to have a cryopreserved TNC dose of at least 1.5 x 10^7 TNC/ recipient body weight (TNC/ kg).\r\n* Each CB unit will be required to have a cryopreserved CD34+ cell dose of at least 1.0 x 10^5 CD34+ cells/ recipient body weight (CD34+/kg).\r\n* A minimum of one domestic will be reserved as a backup unit.
Participants who will undergo HCT from the following donor types are eligible:\r\n* 5/6 or 6/6 (HLA-A, B, DR) matched related donor\r\n* 7/8 or 8/8 (HLA-A, B, DR, C) matched unrelated donor. Matching in the unrelated setting must be at the allele level
Lack of a human leukocyte antigen (HLA) matched donor or need to proceed fast to transplantation when a patient does not have an immediately available matched unrelated donor (typed by high-resolution in the registry);
Patient with either one or both:\r\n* Two 5/8 HLA or better high resolution matched umbilical cord blood (UCB) grafts with a cell dose of 2.0 x 10^7 total nucleated cell (TNC)/kg each, or\r\n* A related haplo-identical donor
Patient must have planned to receive either a myeloablative or reduced-intensity conditioning regimen and have an unrelated donor who is HLA matched or single-allele mismatched
Patient in CR or has a bone marrow failure disorder or non-malignant hematologic or immune disorder: Does NOT have a sibling donor or 12/12 HLA matched unrelated donor available OR treating clinician considers haploidentical transplant preferable (despite sibling donor availability or 12/12 HLA matched donor availability) due to patient’s clinical status
Patient with hematologic malignancy not in CR: Does NOT have a 10/12 (or better) HLA matched related or unrelated donor available OR treating clinician considers haploidentical transplant preferable (despite sibling donor availability or 10/12 or better HLA matched donor availability) due to patient’s clinical status
Patients with donor specific HLA antibodies with a titer greater than 2000 MFI (whether or not they have undergone a desensitization protocol)
Patients must express HLA-A*0201
Patients must have an adult donor for HCT who is adequately HLA matched by institutional standards (includes HLA-matched related or unrelated donors, and HLA-mismatched family donors, including haploidentical donors) and is either: \r\n* HLA-A*0201 positive and HA-1(H) negative (RS_1801284: G/G) or \r\n* HLA-A*0201 negative
Patients must have an adult donor for HCT who is adequately HLA matched by institutional standards (includes HLA-matched related or unrelated donors, and HLA-mismatched family donors, including haploidentical donors) and is either: \r\n** HLA-A*0201 positive and HA-1(H) negative (RS_1801284: G/G) or\r\n** HLA-A*0201 negative
Available related donor who is CMV+ and HLA-haploidentical or better but not fully HLA-matched
Patients must be human leukocyte antigen (HLA) typed at high resolution using deoxyribonucleic acid (DNA) based typing at HLA-A, -B, -C and DRB1 and have an available related haploidentical bone marrow donor with 2, 3, or 4 (out of 8) HLA-mismatches; a unidirectional mismatch in either the graft versus host or host versus graft direction is considered a mismatch
Availability of an 8 of 8 (HLA-A, B, C and DRB1) HLA matched sibling or matched unrelated donor
Presence of donor directed HLA antibodies
HLA-MATCHED UNRELATED DONOR: FHCRC matching allowed will be grades 1.0 to 2.1; unrelated donors who are prospectively:\r\n* Matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing; \r\n* Only a single allele disparity will be allowed for HLA-A, B, or C as defined by high resolution typing
HLA-MISMATCHED UNRELATED DONOR: Unrelated volunteer donors who are mismatched with the recipient within one of the following limitations:\r\n* Mismatch for one HLA class I antigen with or without an additional mismatch for one HLA-class I allele, but matched for HLA-DRB1 and HLA-DQ, OR \r\n* Mismatched for two HLA class I alleles, but matched for HLA-DRB1 and HLA-DQ\r\n* HLA class I HLA-A, -B, -C allele matched donors allowing for any one or two DRB1 and/or DQB1 antigen/allele mismatch
HLA-MISMATCHED UNRELATED DONOR: HLA-matching must be based on results of high resolution typing at HLA-A, –B, -C, - DRB1, and –DQ
HLA-MISMATCHED UNRELATED DONOR: If the patient is homozygous at the mismatch HLA class I locus or II locus, the donor must be heterozygous at that locus and one allele must match the patient (i.e., patient is homozygous A*01:01 and donor is heterozygous A*01:01, A*02:01); this mismatch will be considered a one-antigen mismatch for rejection only
HLA-A*0201 (HLA-A2.1) positivity by molecular subtyping
Available HLA-matched or better but not fully HLA-matched (2/4 or 3/4 antigens) related donor (aged 18 to 75 years) with donor/recipient match based on a minimum of intermediate resolution deoxyribonucleic acid (DNA) based class I typing of the A and B locus who is cytomegalovirus (CMV) seropositive
DONOR: Haploidentical by human leukocyte agent (HLA)-typing\r\n* Haploidentical family members, between the ages of 18 and 65 years, identified as an eligible donor by HLA-typing.; a biological parent will generally be used as the donor
DONOR: Donor preference based on KIR/KIR ligand mismatch\r\n* In addition to HLA determination, KIR genotyping will be performed on potential donors; when more than one potential donor is available, preference will be given to the donor who demonstrates KIR incompatibility with recipient HLA class I ligands defined as the donor expressing a KIR gene for which the corresponding HLA class I ligand is not expressed by the recipient; KIR genotyping and HLA class I typing will be performed in the University of Wisconsin HLA laboratory; if all potential donors show the same degree of KIR/KIR-ligand mismatch, donors will be preferentially selected based on B haplotype KIR gene content
Use of mobilized peripheral blood stem cells from fully human leukocyte antigen (HLA)-matched related or unrelated donor as a graft source
Patients must have the HLA-A*02:01 allele
Patients must be HLA-A*1101 positive
Subject is HLA-A*02:05 positive in either allele; Subject has HLA-A*02:07 as the sole HLA-A*02 allele (e.g., a subject with HLA alleles A*02:04 and A*02:07 is eligible); or Subject has any A*02 null allele (designated with an \N\, e.g., A*02:32N) as the sole HLA-A*02 allele
Patients must have an HLA-matched related donor or an HLA-matched unrelated donor who meets standard Seattle Cancer Care Alliance (SCCA) and/or National Marrow Donor Program (NMDP) or other donor center criteria for peripheral blood stem cell (PBSC) or bone marrow donation, as follows:\r\n* Related donor: related to the patient and genotypically or phenotypically identical for HLA-A, B, C, DRB1 and DQB1; phenotypic identity must be confirmed by high-resolution typing\r\n* Unrelated donor:\r\n** Matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing; OR\r\n** Mismatched for a single allele without antigen mismatching at HLA-A, B, or C as defined by high resolution typing but otherwise matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing\r\n** Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment; the recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain panel reactive antibody (PRA) screens to class I and class II antigens for all patients before hematopoietic cell transplant (HCT); if the PRA shows > 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained; the donor should be excluded if any of the cytotoxic cross match assays are positive; for those patients with an HLA Class I allele mismatch, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results; a positive anti-donor cytotoxic crossmatch is an absolute donor exclusion\r\n* Patient and donor pairs homozygous at a mismatched allele in the graft rejection vector are considered a two-allele mismatch, i.e., the patient is A*0101 and the donor is A*0102, and this type of mismatch is not allowed
Lack of an HLA matched donor or need to proceed fast to transplantation when a patient does not have an immediately available matched unrelated donor (typed by high-resolution in the registry)
DONOR: Genotypically haploidentical as determined by HLA typing\r\n* Preferably a non-maternal HLA haploidentical relative due to data of high incidence of graft failure with use of maternal HLA haploidentical cells\r\n* Eligible donors include biological parents, siblings or half-siblings, children, or cousins in rare instances
Patient must not have a 10/10 HLA matched family member or unrelated donor.
Lack human leukocyte antigen (HLA)-identical related donor
Availability of at least one HLA- haploidentical (i.e. >= 5/10 and =< 8/10 HLA match) related donor (HLA-A, B, C, DR, and DQ loci) who is available to donate CD34+ cells
Availability of at least one 4/6 HLA-matched (HLA-A, B, and DR loci) cord blood unit from the National Marrow Donor Program (NMDP). The cord blood unit must contain a minimum total nucleated cell (TNC) (prior to thawing) of at least 2x10^7 cells per kilogram of recipient body weight
HLA identical (6/6) related donor available and readily accessible at time of transplantation evaluation
Available human leukocyte antigen (HLA)-matched or better but not fully HLA-matched (2/4 or 3/4 antigens) related donor (aged 18 to 75 years) with donor/recipient match based on a minimum of intermediate resolution deoxyribonucleic acid (DNA) based class I typing of the A and B locus who is CMV seropositive
Patients undergoing an unmodified transplant must have a related or unrelated marrow or peripheral blood stem cell (PBSC) donor as follows:\r\n* Sibling donor must be a 6/6 match for HLA-A and -B at intermediate (or higher) resolution, and HLA-DRB1 at high resolution using deoxyribonucleic acid (DNA)-based typing\r\n* Unrelated donor must be an 8/8 match at HLA-A, -B, -C and –DRB1 at high resolution using DNA-based typing
Relapsed AML after human leukocyte antigen (HLA)-matched related or unrelated allogeneic hematopoietic cell transplant (per IWG definition of relapse)
Availability of a CB unit matched with the patient at 4, 5, or 6/6 human leukocyte antigen (HLA) class I (serological) and II (molecular) antigens.
Human leukocyte antigen (HLA)-haploidentical related donor (aged 12 to 75 years) with donor/recipient match based on a minimum of intermediate resolution deoxyribonucleic acid (DNA) based class I typing of the A and B locus (at least 2/4 class I allele)
HLA-haploidentical related donor (aged 12 to 75 years) with donor/recipient match based on a minimum of intermediate resolution DNA based class I typing of the A and B locus (at least 2/4 class I allele)
Recipients must have received an human leukocyte antigen (HLA)-identical sibling allogeneic hematopoietic stem cell transplant, or an 8/8-matched (HLA-A, B, C, DR) other-than-sibling related donors, or a 8/8-matched (HLA-A, B, C, DR) unrelated donor (URD) allo-hematopoietic stem cell transplantation (HSCT) for an eligible CD30+ lymphoma
Patients must have one related donor who is human leukocyte antigen (HLA) mismatched in the GVHD direction at two or more HLA loci
Available HLA-haploidentical or mismatched related donor (aged 12 to 70 years) with donor/recipient match based on a minimum of intermediate resolution deoxyribonucleic acid (DNA) based class I typing of the A and B locus (at least 2/4 class I allele)
DONOR: HLA-haploidentical or mismatched related donor/recipient match based on a minimum of intermediate resolution DNA based Class I typing of the A and B locus (at least 2/4 class I allele)
Subject is HLA-A*02:01 or HLA-A*02:06 positive.
Subject is HLA-A*02:05, HLA-B*15:01 and/or HLA-B*46:01 positive.
Must be HLA- A*02:01 positive; (retesting is not required for patients who have previous documented HLA- A*02:01 positivity)
At least one haploidentical (5/10 antigen mismatched) related donor is available for bone marrow harvest\r\n* Molecular based HLA typing for the HLA-A, -B, -Cw, -DRB1 and -DQB1 loci to the resolution is needed to establish haploidentity\r\n* A minimum match of 5/10 is required\r\n* No availability of an 8/8 HLA-matched related or unrelated donor or clinical urgency for transplant (e.g., needed within 4-8 weeks) at which time an acceptable unrelated donor will not be available
IMMUNE RECONSTITUTION STUDY ONLY: At least one haploidentical (5/10 antigen mismatched) related donor is available for bone marrow harvest\r\n* Molecular based HLA typing for the HLA-A, -B, -Cw, -DRB1 and -DQB1 loci to the resolution is needed to establish haploidentity\r\n* A minimum match of 5/10 is required\r\n* No availability of an 8/8 HLA-matched related or unrelated donor or clinical urgency for transplant (e.g., needed within 4-8 weeks) at which time an acceptable unrelated donor will not be available
Patient must be HLA typed at high resolution using deoxyribonucleic acid (DNA) based typing at the following loci: HLA-A, -B, -C, and DRB1
Patient must have available one or more potential first (biologic mother, sister, half-sister, or daughter) or second-degree related female donor; mothers and daughters have a 100% chance of being haploidentical matches, sisters a 75% chance of being matched or haploidentical, and second degree relatives have a 50% chance of being haploidentical matches; the donor and recipient must be HLA identical for at least one antigen at HLA-A, -B, -C and HLA-DRB1
Must have no 7/8 or 8/8 HLA-matched sibling donor - patients >= 70 and =< 75 years of age may be eligible if they have a co-morbidity score =< 2
Patients and selected donor must be HLA typed at high resolution using deoxyribonucleic acid (DNA) based typing at the following HLA-loci: HLA-A, -B, -C and DRB1; donors must be HLA-haploidentical relatives including, but not limited to, children, siblings, or parents, defined as having a shared HLA haplotype between donor and patient at HLA-A, -B, -C, and -DRB1
Lack of a human leukocyte antigen (HLA) matched related donor, lack of an immediately available 8/8 HLA matched unrelated donor
All candidates for this study must have a human leukocyte antigen (HLA) (A, B, C, DR) identical siblings who is willing to donate bone marrow for primed blood stem cells or an 8/8 allele-matched unrelated donor
DONOR: HLA 6/6 matched related or unrelated donor
Persons with a HLA matched sibling donor
DONOR: Partially HLA-mismatched relative (allele level matched at 4 to 7 of 8 HLA loci: -A, -B, -C, and -DRB1)
HLA phenotype positive.
Patients must be major histocompatibility complex, class I, A (HLA-A)*02 by low resolution typing, and HLA-A*02:01 by one of the high resolution type results
No suitable fully matched related (6/6 match for human leukocyte antigen [HLA]-A and B at intermediate or high resolution and DRB1 at high resolution using deoxyribonucleic acid [DNA] based typing) donor if under age 25 years
DONOR: \r\n* HLA haploidentical relative of the patient; a unidirectional mismatch in either the graft versus host or host versus graft direction is considered a mismatch; the donor and recipient must be identical at least one allele (high resolution DNA-based typing) at the following genetic loci: HLA-A, -B, -C, and DRB1 \r\n* If patient over age 25 years, may use HLA identical sibling donor\r\n* If patient has inherited bone marrow failure syndrome (IBMFS) and clear evidence of same disorder in potential related donors, unrelated donor may be used; unrelated donor must be a 10/10 match using HLA-A, -B, -C, DRB1, and DPB1; unrelated donor may also be used in case of donor specific antibodies to related donors or other clinical causes of unsuitable related donors
Presence of anti-donor HLA antibodies (positive anti-donor HLA antibody is defined as a positive cross-match test of any titer by complement-dependent cytotoxicity or flow cytometric testing or the presence of anti-donor HLA antibody to the high expression loci HLA-A, B, C, or DRB1 with mean fluorescence intensity [MFI] > 1000 by solid phase immunoassay)
Available human leukocyte antigen (HLA)-haploidentical donor that meets the criteria
DONOR: HLA-haploidentical donor/recipient match by molecular typing at the HLA-A, HLA-B and HLA-DRB1 loci
Human leukocyte antigen (HLA)-A*0201 (HLA-A2.1) positivity by molecular subtyping
Patients must be HLA-A*0201 positive
HLA-A*02:01 expression
Lack of HLA-A*02:01 expression
Matched related or unrelated (8/8 matched at human leukocyte antigen [HLA]-A, -B, -C, -DRB1) donor according to institutional standards
Availability of appropriate, willing, human leukocyte antigen (HLA)-matched related stem cell donor
Patient Human Leukocyte Antigen (HLA) typing should demonstrate HLA-A*01, and/or HLA-A*02, and/or HLA-A*24 restriction.
Patients with HLA-A alleles not belonging to any of the following subtypes: HLA-A*01, or HLA-A*02, or HLA-A*24.
No more than 1 antigen mismatch at human leukocyte antigen (HLA)-A, B, C, DRB1 and DQB1 locus for either related or unrelated donor
DONOR: Donors must match at least one allele of HLA-A, B, C, DR and DP (or permissive mismatch in the case of DP) by high resolution typing; a HLA-matched family member is ineligible to serve as a donor; eligible donors include biological parents, siblings, half-siblings or children
Human leukocyte antigen (HLA)-A*0201 (HLA-A2.1) positivity by molecular subtyping (blood test or buccal swab, historical documentation acceptable)
DONOR:\r\n* PART 1: Donor must be a 5/6 or 6/6 human leukocyte antigen (HLA)-matched sibling willing to donate PBSC for transplant\r\n* PART 2: Donor must be a 5/6 or 6/6 HLA-matched sibling or >= 3/6 HLA haploidentical donor willing to donate PBSC for transplant; haploidentical donors will be allowed to participate upon investigator decision and based on the data reached from 5/6 or 6/6 HLA matched transplant done during Part 1 of the study
HLA-matched stem cell donor, either related (6/6 or 5/6 loci matched) or unrelated (8/8 or 7/8 loci matched) \r\n* Note: unrelated donors should be matched at HLA-A, -B, -C, and -DRB1 loci; however, a single locus mismatch will be acceptable in the event a more closely matched donor is not available
Patients must have a related donor who is human leukocyte antigen (HLA) mismatched at 2, 3, or 4 antigens at the HLA-A; B; C; DR loci in the graft-versus-host disease (GVHD) direction; (patients with related donors who are HLA identical or are a 1-antigen mismatch may be treated on this therapeutic approach, but will have their outcomes will not be part of the statistical aims of the study); the HLA matched related category includes patients with a syngeneic donor
An 10/10 or 8/8 human leukocyte antigen (HLA) matched (high resolution typing at A, B, C, DRB1, DQ1) sibling or unrelated donor
DONOR: In addition to HLA determination, KIR genotyping will be performed on potential donors; preference will be given to donors who demonstrate KIR incompatibility with recipient HLA class I ligands defined as the donor expressing a KIR gene for which the corresponding HLA class I ligand is not expressed by the recipient; KIR genotyping and HLA class I typing will be performed in the University of Wisconsin HLA laboratory; the following KIR genes and corresponding HLA class I ligands will be analyzed:\r\n* KIR Gene; HLA Class I Ligand\r\n* KIR3DLI; HLA Bw4\r\n* KIR2DL1; HLA C^LYS80\r\n* KIR2DL2/3; HLA C^ASN80\r\nIf all potential donors show the same degree of KIR/KIR-ligand mismatch, donors will be preferentially selected based on B haplotype KIR gene content according to the method described by Cooley et al., using the donor KIR B-content group calculator
Patients must be human leukocyte antigen (HLA)-A2+
HLA-A2 negative patients
Patients with hematologic diseases who have undergone T-cell depleted reduced intensity/non-ablative allogeneic transplantation, using a 7-8/8 HLA-matched related or unrelated donor or 4-6/8 HLA-matched related donor; this may include patients with a mixed chimeric state or disease persistence or at high risk of relapse
HLA 4-8/8 MATCHED RELATED DONOR
Adult donors must be an HLA 4-8/8 match with the patient and must be capable of providing informed consent
8/8 HLA MATCHED UNRELATED DONORS
The recipient must have a related donor genotypically human leukocyte antigen (HLA)-A, B,C and DRB1 loci haploidentical to the recipient
No HLA matched sibling or matched unrelated donor is available
HLA-matched or partially matched (7/8 or 8/8) related or unrelated donor is available to donate
DONOR: Genotypically haploidentical as determined by HLA typing, preferably a non-maternal HLA haploidentical relative; eligible donors include biological parents, siblings or half siblings, or children
Donor criteria: availability of a donor either an human leukocyte antigen (HLA) matched sibling donor (MSD) or a haploidentical (5-9/10 HLA matched); alternatively a 8/8 HLA matched unrelated donor (MUD) by high resolution typing is immediately available
Has a human leukocyte antigen (HLA)-matched or single allele-mismatched adult sibling serving as donor
DONOR: HLA-matched or single allele mismatched sibling of enrolled transplant patient
No more than 1 antigen mismatch at HLA-A, -B, -C, -DRB1 or -DQB1 locus for unrelated donor with peripheral blood and bone marrow as the hematopoietic stem cell source; and
Human leukocyte antigen (HLA)-A2 positive based on flow cytometry
No suitable human leukocyte antigen (HLA) matched sibling donor is available and the patient has one or more potentially suitable HLA matched unrelated donor(s) in the National Marrow Donor Registry or other available registry\r\n* The evaluation of donors shall be in accordance with existing National Marrow Donor Program (NMDP) Standard Policies and Procedures\r\n* HLA-matched donors are defined by allele matching at HLA-A, -B, -C, and DRB1 (8/8)
All study participants must have one of the HLA alleles: HLA-A*02, HLA-A*03, HLAA*11, or HLA-A*24
Availability of an 8/8 matched donor at A, B, C, and DR loci; mismatch at human leukocyte antigen (HLA) DQ are permissible; matched related or unrelated donors are acceptable; peripheral blood or bone marrow stem cells are acceptable
DONOR: Human leukocyte antigen (HLA)-matched or 1 antigen mismatched sibling donor
DONOR: 10 of 10 HLA-matched or 1 allele mismatched (9 of 10) unrelated donor
DONOR: The CB graft(s) must be matched at 4-6 HLA-A, B, DR Beta 1 (DRB1) loci with the recipient and therefore may include 0-2 mismatches at the A or B or DRB1 loci; unit selection will be based on cryopreserved nucleated cell dose and intermediate resolution A, B antigen and DRB1 allele typing for determination of HLA-match; while HLA-C antigen/allele level typing is not considered in the matching criteria, if available, it may be used to optimize unit selection
Human leukocyte antigen (HLA)-identical sibling or 8/8 matched unrelated donor transplant
Inadequate >= 7 out of 8 human leukocyte antigen (HLA) loci-matched related donor or HLA-matched unrelated donor
Available familial haploidentical (4 to 6 out of 8 HLA loci-matched) donor
DONOR: Donor with full haplotype HLA-mismatch will be preferred (4 out of 8 HLA match) to maximize graft-versus-leukemia (GVL)
No available suitable human leukocyte antigen (HLA)-matched donor
DONOR: HLA typing per University of Alabama (UAB) standard
Absence anti-human leukocyte antigen (HLA) antibodies specific for HLA class I antigens expressed by the coagulation factor III (thromboplastin, tissue factor) (F3).cytosine deaminase (CD).carboxylesterase (CE) NSCs
Patients who do not have human leukocyte antigen (HLA)-matched (defined as matched in HLA A, B, C, and DRB1) related or unrelated donors
Cord blood units available through National Marrow Donor Program (NMDP) with the following minimal criteria;\r\n* HLA Match: 4/6 or better match (HLA A, B, DRB1)\r\n* Cell dose: minimum of 2 x 10^7 total number of nucleated cells (TNC)/kg pre thaw
Molecular based human leukocyte antigen (HLA) typing will be performed for the HLA-A, -B, -Cw, DRB1 and –DQB1 loci to the resolution adequate to establish haplo identity; a minimum match of 5/10 is required; an unrelated donor search is not required for a patient to be eligible for this protocol if the clinical situation dictates an urgent transplant; clinical urgency is defined as 6-8 weeks from referral or low-likelihood of finding a matched, unrelated donor
HLA-matched donor able to donate
Patients must be HLA-A*01 positive
There are CMVpp65-specific T-cells available in appropriate doses in the MSKCC Adoptive Immune T-cell Therapy Bank that are matched with the patient for 1 HLA allele and that exhibit CMVpp65-specific cytotoxic activity that is restricted by an HLA allele shared by the patient
Must have a suitable donor defined as a sibling matched at 5/6 or 6/6 antigens (human leukocyte antigen [HLA]-A, B, and DRB1) or an unrelated volunteer matched at 7/8 or 8/8 HLA alleles (HLA-A, B, C, and DRB1)
DONOR: “High resolution” typing at HLA-A, B, C and DRB1 alleles\r\n* Single antigen mismatch for siblings and single allele mismatch for volunteer unrelated donors is acceptable\r\n* Donors must be >= 17 years of age
Patients must be human leukocyte antigen (HLA)-DP4 positive
All candidates for this study must have a human leukocyte antigen (HLA) (A, B, C, DR) identical siblings who is willing to donate bone marrow or primed blood stem cells or a 10/10 allele matched unrelated donor; a single allele mismatch at A, B, C, DR or DQ and a killer immunoglobulin-like receptor (KIR) mismatch at C will be allowed; all ABO blood group combinations of the donor/recipient are acceptable
Patients must have a related, genotypically HLA identical donor, or they must have a unrelated donor who is 8/8 HLA match by high resolution typing
DONOR: HLA matching criteria
6/6 human leukocyte antigen (HLA) matched family donor available
Presence of a willing adult human leukocyte antigen (HLA)-matched sibling (excluding identical twin) or HLA-matched unrelated donor meeting all the criteria for routine allo HSCT; all donors will be evaluated for eligibility and suitability per the standard of care according to the Foundation for the Accreditation of Cellular Therapy (FACT) and National Marrow Donor Program (NMDP) guidelines
Patients must be human leukocyte antigen (HLA)-A*0201 positive
Available human leukocyte antigen (HLA)-haploidentical donor that meets the following criteria:\r\n* Related donor (sibling, offspring, or offspring of sibling)\r\n* At least 18 years of age\r\n* HLA-haploidentical donor/recipient match by at least class I serologic typing at the A&B locus\r\n* In general good health, and medically able to tolerate leukapheresis required for harvesting the NK cells for this study\r\n* Negative for hepatitis, human T-cell lymphotropic virus (HTLV), and human immunodeficiency virus (HIV) on donor viral screen\r\n* Not pregnant\r\n* Voluntary written consent to participate in this study
RECIPIENT: 10/10 or 9/10 human leukocyte antigen (HLA)-matched related or unrelated donor or a haploidentical related donor
RECIPIENT: No available 10/10 or 9/10 HLA-matched related or unrelated donor, 4/6 (or greater) matched UCB unit(s) with a total dose of greater than or equal to 3.5 x 10^7 TNC/kg, or haploidentical related donor
MATCHED RELATED DONOR: Related donor matched at 9/10 or 10/10 HLA-A, B, C, DR, and DQ loci by high resolution typing 63
MATCHED UNRELATED DONOR: Unrelated donor matched at 10/10 or 9/10 HLA-A, B, C, major histocompatibility complex, class II, DR beta 1 (DRB1), and major histocompatibility complex, class II, DQ beta 1 (DQB1) loci by high resolution typing
HAPLOIDENTICAL RELATED DONOR: A haploidentical donor is a related donor that shares one haplotype in common with the recipient such that HLA compatibility will be a minimum of 5 out of 10 HLA loci matched; the HLA loci to be tested will be HLA A, B, Cw, DRB1, and DQB1; a minimum number of mismatches is desirable; however if several options are available the selection of a donor will be based on the loci where the mismatch occurs and the relative importance of its potential immunological function; donor-recipient pairs will initially be typed molecularly to provide a low resolution typing (antigen-level) to aid in the selection of the potential donor; upon review of the familial inheritance pattern, a qualified HLA staff member will review haplotype inheritance; high resolution (allele level) typing will be performed; final selection of a donor will be in consultation with National Cancer Institute (NCI) physicians and qualified HLA personnel; haploidentical related donors for pediatric recipients must be 6 years of age or older; if more than one haploidentical related donor is available, we will evaluate each donor individually according to overall health, ABO matching, cytomegalovirus (CMV), etc. to select the donor
Patient must have an identified HLA (A,B,C,DR) compatible related or unrelated donor who is age 16 years of age or older and weighs at least 110 pounds for the stem cell donation
Patients who are deemed clinically fit for non-myeloablative transplantation and have a matched related or unrelated donor (9/10 human leukocyte antigen [HLA] allele matched or better using high resolution typing) eligible to provide a filgrastim (G-CSF) mobilized peripheral blood stem cell graft by institutional donor selection criteria; syngeneic donors are not permitted
Does not have a suitable human leukocyte antigen (HLA)-matched sibling donor (MSD) or volunteer HLA-matched unrelated donor (MUD) available in the necessary time for stem cell donation, or is not a candidate for MSD or MUD hematopoietic cell transplantation (HCT) due to refractory disease
Presence of a suitable first-degree related, human leukocyte antigen (HLA)-haploidentical or HLA-matched bone marrow donor\r\n* The donor and recipient must be identical at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1; a minimum match of 5/10 is therefore required, and will be considered sufficient evidence that the donor and recipient share one HLA haplotype
DONOR: Lack of recipient anti-donor HLA antibody; Note: in some instances, low level, non-cytotoxic HLA specific antibodies may be permissible if they are found to be at a level well below that detectable by flow cytometry; this will be decided on a case-by-case basis by the principal investigator (PI) and one of the immunogenetics directors
DONOR: Donors will be pre-selected on the basis of HLA haploidentity
HLA-A2 positive based on flow cytometry
Patients must have a related donor who is at least a 2-4/8 antigen mismatch at the human leukocyte antigen (HLA)-A; B; C; DR loci; patients with only a 1 out of 8 mismatch in the GVH direction will be classified in the matched related category
Must have matched unrelated donor (8 of 8 HLA match at A, B, C, and DR loci) by high resolution deoxyribonucleic acid (DNA) typing
Patients must have a cord blood (CB) unit available which is matched with the patient at 4, 5, or 6/6 human leukocyte antigen (HLA) class I (serological) and II (molecular) antigens
An 8/8 human leukocyte antigen (HLA) matched (high resolution typing at A, B, C, DRB1) sibling or unrelated donor
Human leukocyte antigen (HLA)-A*0201 (HLA-A2.1) positivity by molecular subtyping
Human leukocyte antigen (HLA)-A2 positive
Availability of a related or unrelated donor with a 7/8 or 8/8 match for HLA-A, B, C, and DRB1.
Positive patient anti-donor HLA antibody, which is deemed clinically significant.
Patients must express HLA-A*0201
Patients must have an HLA-matched donor of hematopoietic stem cells (related or unrelated)
DONOR: Patient and donor (related or unrelated) must be HLA-matched and express HLA-A*0201
Patients who have undergone an alemtuzumab or thymoglobulin-containing allogeneic transplant procedure from an human leukocyte antigen (HLA)-identical family donor, or an 8/8 HLA-matched unrelated donor
Must have two partially HLA-matched CBUs for part 1; and one partially HLA-matched CBU for part 2
HLA-matched related donor able to donate
Patients developing EBV lymphomas or lymphoproliferative disorders following an allogeneic organ transplant; in these cases, the lymphoma is usually of recipient origin; EBV-specific T-cells will be selected from the MSKCC bank expanded from an EBV-seropositive normal donor who is at least matched for 1) 2 HLA antigens and 2) one restricted allele with the EBV lymphoma; if the origin of the lymphoma is unknown, T-cells partially matched with the recipient transplant will be used, since these lymphomas are usually of host origin; using this approach to donor selection, it is expected that the EBV-specific, HLA restricted cytotoxic T-cells expanded from the HLA partially-matched donor would be able to recognize and kill lymphoma cells presenting EBV antigens in the context of an appropriate HLA restricting element; priority will be given to the use of partially matched EBV specific T cells known to be restricted by an HLA allele shared by the lymphoma (or, if known, the patient)
Patients with acquired immunodeficiency syndrome (AIDS) developing EBV lymphomas or lymphoproliferative diseases as a consequence of the profound acquired immunodeficiency induced by human immunodeficiency virus (HIV); for such patients, EBV specific T-cells from third party seropositive donors who are HLA compatible in 1) at least 2 HLA antigens and 2) one restricted allele shared by the patient will be used; selection of T cells known to be restricted by an HLA allele shared by the patient will be given priority
Patients must have an HLA-identical related or HLA-matched unrelated donor
DONOR: Donor's high resolution human leukocyte antigen (HLA) typing must be available for review
HLA-A*0201 positive by Central Assay
Patients must have a related donor who is human leukocyte antigen (HLA) mismatched at 2, 3, or 4 antigens at the HLA-A; B; C; DR loci in the GVHD direction; (patients with related donors who are HLA identical or are a 1-antigen mismatch may be treated on this therapeutic approach, but will have their outcomes will not be part of the statistical aims of the study)
Patients for whom an human leukocyte antigen (HLA) matched sibling donor bone marrow transplant is being actively pursued will not be eligible for study until it is determined that no sibling donor is available or that a stem cell transplant is not feasible during the time the patient might be on study\r\n* No patient will be included in this study as an alternative to a clinically indicated HLA matched sibling donor stem cell transplant\r\n* If an HLA matched sibling donor is identified, but stem cell or marrow collection is not feasible (e.g., donor is in utero, is a newborn from whom cord blood was not collected, or is unable to undergo a donation procedure because of ill health), a patient may be included in the study at the discretion of the investigators
Patients must have a related donor who is either human leukocyte antigen (HLA)-identical or a one antigen mismatch at the HLA- A; B; C; and DR loci
Related or unrelated umbilical cord blood unit with 0-1 antigen mismatch at human leukocyte antigen (HLA)-A and B (at low resolution) and DRB1 (at high resolution) with a total nucleated cell dose of >= 4 x 10^7/kg
Absence of a suitable related or unrelated bone marrow donor who is molecularly matched at HLA-A, B, Cw, DRB1, and DQB1
Absence of a suitable partially HLA-mismatched (haploidentical), first-degree related donor; Note: determination of matching is based on allele or allele group level typing; to be considered haploidentical, the donor and recipient must be identical at least one allele of each of the following genetic loci: HLA-A, -B, -Cw, -DRB1, and –DQB1; a minimum match of 5/10 is therefore required, and will be considered sufficient evidence that the donor recipient share one HLA haplotype; donors who are homozygous for the CCR5delta32 polymorphism are given preference
DONOR: The donor and recipient must be identical at least 5 HLA alleles based on high resolution typing of HLA-A, -B, -Cw, -DRB1, and -DQB1, with at least one allele matched for a HLA class I gene (HLA-A, -B, or -Cw) and at least one allele matched for a class II gene (HLA-DRB1 or -DQB1)
DONOR: Lack of recipient anti-donor HLA antibody; Note: in some instances, low level, non-cytotoxic HLA specific antibodies may be permissible if they are found to be at a level well below that detectable by flow cytometry; this will be decided on a case-by-case basis by the PI and one of the immunogenetics directors; pheresis to reduce anti-HLA antibodies is permissible; however eligibility to proceed with the transplant regimen would be contingent upon the result
Available 10/10 or 9/10 human leukocyte antigen (HLA)-matched related or unrelated donor or a haploidentical related donor
No available 10/10 or 9/10 HLA-matched related or unrelated donor or haploidentical related donor
MATCHED RELATED DONOR: Related donors matched at HLA-A, B, C, DR, and DQ loci by high resolution typing (10/10 antigen/allele match) are acceptable donors; alternatively, a 9/10 matched related donor can be used
MATCHED UNRELATED DONOR: Unrelated donor matched at 10/10 or 9/10 HLA-A, B, C, DR, and DQ loci by high resolution typing
HAPLOIDENTICAL RELATED DONOR: A haploidentical donor that shares one haplotype in common with the recipient such that HLA compatibility will be a minimum of 5 out of 10 HLA loci matched; the HLA loci to be tested will be HLA A, B, Cw, DRB1, and DQB1; a minimum number of mismatches is desirable; however if several options are available the selection of a donor will be based on the loci where the mismatch occurs and the relative importance of its potential immunological function; donor-recipient pairs will initially be typed molecularly to provide a low resolution typing (antigen-level) to aid in the selection of the potential donor; upon review of the familial inheritance pattern, a qualified HLA staff member will review haplotype inheritance; high resolution (allele-level) typing will be performed; final selection of a donor will be in consultation with National Cancer Institute (NCI) physicians and qualified HLA personnel; if more than one haploidentical related donor is available, we will evaluate each donor individually according to overall health, ABO matching, cytomegalovirus (CMV), etc. to select the donor
DONOR: Any matched sibling donor (matched at HLA A, B, C by intermediate resolution typing and HLA-DRB1 by high resolution typing), or unmatched unrelated donor (matched at HLA A, B, C, DRB1 by high resolution typing) will be considered a suitable donor
HLA-A2 positive based on flow cytometry
Molecular based human leukocyte antigen (HLA) typing will be performed for the HLA-A, -B, -Cw, -DRB1 and -DQB1 loci to the resolution adequate to establish haplo-identity; a minimum match of 5/10 is required; an unrelated donor search is not required for a patient to be eligible for this protocol if the clinical situation dictates an urgent transplant; clinical urgency is defined as 6-8 weeks from referral or low-likelihood of finding a matched, unrelated donor
HLA-matched or single allele-mismatched donor able to donate
Cross-over to other tandem autologous-allogeneic research protocol (#1409 or other appropriate protocol) will be allowed if a suitable HLA-matched related or unrelated donor is identified before receiving the allogeneic transplantation and if the patient meets the eligibility criteria of the subsequent study
Cross-over from other tandem autologous-allogeneic research protocol (#1409 or other appropriate protocol) will be allowed if the patient loses the suitable HLA-matched related or unrelated donor but has an available HLA-haploidentical donor before receiving the allogeneic transplantation and if the patient meets the eligibility criteria of the subsequent study
DONOR: Related donors who are genotypically identical for one HLA haplotype and who may be mismatched at the HLA-A, -B, -C or DRB1 loci of the unshared haplotype with the exception of single HLA-A, -B or -C allele mismatches
Have a related or unrelated human lymphocyte antigen (HLA) -identical donor or one antigen/allele mismatched in HLA-A, B, C or DRB1
DONOR: Human leukocyte antigen (HLA) matching:\r\n* Minimum requirement: The cord blood (CB) graft(s) must be matched at a minimum at 4/6 HLA-A, B, DRB1 loci with the recipient; therefore 0-2 mismatches at the A or B or DRB1 loci based on intermediate resolution A, B antigen and DRB1 allele typing for determination of HLA-match is allowed\r\n* HLA-matching determined by high resolution typing is allowed per institutional guidelines as long as the minimum criteria (above) are met
2 UCB units selected according to current Memorial Sloan-Kettering Cancer Center (MSKCC) unit selection algorithm; high resolution 8 allele HLA typing will be performed; unit selection will occur based on 8 allele HLA-match and cluster of differentiation (CD)34+ dose
Patients with an available 5-6/6 HLA-A, B, DRB1 matched sibling donor
DONOR: Cord blood (CB) donor selection will be based on institutional guidelines and in general should be selected to optimize both human leukocyte antigen (HLA) match and cell dose; additionally, CB grafts shall consist of one or two CB donors based on, but not exclusively determined by, cell dose (total nucleated cell [TNC]/kg and CD34/kg), HLA matching and disease status and indication for transplant; attending preference will be allowed for single versus double unit as well as the degree of mismatching based on patient specific factors, as long as the following minimum criteria are met:\r\n* HLA matching\r\n** Minimum requirement: The CB graft(s) must be matched at a minimum at 4/6 HLA-A, B, DRB1 loci with the recipient. Therefore 0-2 mismatches at the A or B or DRB1 loci based on intermediate resolution A, B antigen and DRB1 allele typing for determination of HLA-match is allowed\r\n** HLA-matching determined by high-resolution typing is allowed per institutional guidelines as long as the minimum criteria are met\r\n* Selection of two CB units is mandatory when a single cord blood unit does not meet the following criteria:\r\n** Match grade 6/6; TNC Dose >= 2.5 x 10^7/kg\r\n** Match grade 5/6 or 4/6; TNC dose >= 4.0 (+/- 0.5) x 10^7/kg\r\n* If two CB units are used, the total cell dose of the combined units must be at least 3.0 x 10^7 TNC per kilogram recipient weight based on pre-cryopreservation numbers, with each CB unit containing a MINIMUM of 1.5 x 10^7 TNC/kg \r\n* The minimum recommended CD34/kg cell dose should be 2 x 10^5 CD34/kg, total dose from a single or combined double\r\n* The unmanipulated CB unit(s) will be Food and Drug Administration (FDA) licensed or will be obtained under a separate investigational new drug (IND), such as the National Marrow Donor Program (NMDP) Protocol 10-CBA conducted under BB IND-7555 or another IND sponsored by (1) a participating institution or (2) an investigator at FHCRC or one of the participating institutions\r\n* FHCRC only: Up to 5% of cord blood product, when ready for infusion, may be withheld for research purposes as long as thresholds for infused TNC dose are met; threshold for double unit transplantation is >= 3.0 x 10^7/kg; these products will be used to conduct studies involving the immunobiology of double cord transplantation and kinetics of engraftment
Patients must have an HLA-A, B, DRB1 identical sibling donor; patients and donors will be typed for HLA-A and B using serological or molecular techniques and for DRB1 using high resolution molecular typing
Recipients with unrelated donor matched at the HLA A, B, DRBI loci, or if < 35 years mismatched at a single HLA A or B, or DRBI locus
Partially matched related donors will be at least haploidentical (matched at >= 3 of 6 HLA A, B, DRB1 loci)
HLA-identical sibling
Must be HLA compatible in 10/10 or 9/10 alleles by 4 digit/allele high-resolution molecular genotyping
Patients who are ineligible for or refuse BMT from a HLA-matched, sibling donor
DONOR: When more than one HLA-haploidentical donor is available, the donor with the lowest number of HLA allele mismatches will be chosen, unless there is HLA cross-match incompatibility, in which case donor selection is the responsibility of the project investigator (PI), in consultation with the immunogenetics laboratory; in cases where there is more than one donor with the least degree of mismatch, donors will be selected based on the most favorable combination of (i) HLA compatibility in cross-match testing and (ii) ABO compatibility:
Matched sibling donor (HLA 8/8), if available, or a unrelated partially HLA matched single unit based on the following priority:\r\n* First (1st) priority: 4/6 matched unit, cell dose >= 5 x 10^7 nucleated cells/kg\r\n* Second (2nd) priority: 5/6 matched unit, cell dose >= 4 x 10^7 nucleated cells/kg\r\n* Third (3rd) priority: 6/6 matched unit, cell dose >= 3 x 10^7 nucleated cells/kg
Patients must have an =< 1 antigen mismatched HLA-A, B, DRB 1 unrelated donor or =< 1 antigen mismatched related (non-HLA-matched sibling) or =< 2 antigen mismatched unrelated umbilical cord blood (UCB) donor; patients and donors will be typed for HLA-A and B using intermediate or high resolution molecular techniques and for DRB 1 using high resolution molecular typing
Available HLA-genotypically identical related donor
The unrelated cord blood donor(s) must be 4-6/6 human leukocyte antigen (HLA)-A, B, DRB1 matched with the recipient (HLA matching using molecular techniques: A and B to antigen level resolution and DR to allele level resolution)
No existing HLA-identical related donor is available
The UCB graft is matched at 4-6 human leukocyte antigen (HLA)-A, B, DRB1 antigens with the recipient; this may include 0-2 antigen mismatches at the A or B or DRB1 loci
< 70 years with an available 5-6/6 HLA-A, B, DRB1 matched sibling donor
Be HLA-A*02+ as determined by Central Laboratory;
Related donors that are matched at HLA 7-8/8 loci (HLA A, B, C, and DRB1 loci) by intermediate resolution
Unrelated donors that are matched at HLA 8/8 (HLA A, B, C, and DRB1 loci); 1 allele/antigen mismatch at HLA-A, -B, -C, or DRB1 may be considered if no other suitable donor available
HLA-Identical Sibling (6/6): Minimal typing necessary is serologic typing for class I (AB) and molecular typing for class II (DRB1)
Matched Unrelated Donor (8/8): Molecular identity at HLA A, B, C and DRB1 by high-resolution typing
Matched Related and Unrelated Donor (7/8): high-resolution molecular typing at the following loci is required: HLA A, B, C and DRB1
Patient Human Leucocyte Antigen (HLA) typing should demonstrate HLA-A*01, and/or HLA-A*02, and/or HLA-A*24 restriction.
Patients without HLA-A1, or HLA-A*02, or HLA-A*24 restriction.
Patients must have two CB units available which are matched with the patient at 4, 5, or 6/6 human leukocyte antigen (HLA) class I (serological) and II (molecular) antigens; each cord must contain at least 1.5 x 10^7 total nucleated cells/Kg recipient body weight (pre-thaw); cord blood units will be procured through the National Marrow Donor Program (NMDP)
Absence of timely and suitable fully HLA matched or one HLA locus mismatched family or unrelated donor and, at Investigator's discretion, absence of other possible therapeutic alternatives
Subjects must be HLA-A2 positive
HLA phenotype positive. Note: Patients who were previously HLA-typed for participation in other Immatics' sponsored clinical trials and were HLA phenotype positive may enter IMA202-101 main screening
Availability of a genetic child, genetic parent or sibling as a potential HLA haploidentical donor
DONOR: Donor must be related to patient and be partially (>= 3/6 antigen) HLA-matched
Patient has at least one medically fit first- or second-degree family member expected to be human leukocyte antigen (HLA) mismatched at 2-9/10 loci; in addition, the prospective donor is willing to voluntarily donate hematopoietic stem cells and sign consent forms
Donors will be pre-selected on the basis of HLA haploidentity
Inclusion Criteria:\n\n          1. Signed informed consent\n\n          2. Patients with one of the life-threatening hematological malignancies:\n\n               -  Acute lymphocytic leukemia (ALL) in CR1 with high-risk features including adverse\n                  cytogenetics such as t(9;22), t(1;19), t(4;11), or MLL gene rearrangements;\n                  greater than 1 cycle to achiever remission or with persistent MRD; ALL in second\n                  or greater remission with or without MRD. Acute myeloid leukemia (AML) in CR1\n                  with high-risk features defined as: Greater than 1 cycle of induction therapy\n                  required to achieve remission; Preceding myelodysplastic syndrome (MDS) or\n                  myeloproliferative disease; Presence of FLT3 mutations or internal tandem\n                  duplications; FAB M6 or M7 classification; Adverse cytogenetics, -5, del 5q, -7,\n                  del7q, abnormalities involving 3q, 9q, 11q, 20q, 21q, 17, +8 [> 3 abnormalities];\n\n               -  AML in second or greater remission, primary induction failure and patients with\n                  relapsed disease;\n\n               -  Advanced chronic myeloid leukemia (CML) who have progressed to blast phase or\n                  accelerated phase and are in need of a transplant and do not have an HLA matched\n                  donor;\n\n               -  MDS with IPSS intermediate-2 or higher or therapy-related MDS.Hodgkin lymphoma or\n                  Non-Hodgkin lymphoma (NHL): relapsed disease where remission duration is less\n                  than 1 year, relapse after previous autologous transplant, or failure to achieve\n                  CR with chemotherapy.\n\n          3. Age ? 18 years and ? 65 years\n\n          4. Deemed eligible for allogeneic stem cell transplantation\n\n          5. Lack of suitable conventional donor (i.e. 8/8 related or unrelated donor) or presence\n             of rapidly progressive disease not permitting time to identify an unrelated donor\n\n          6. HLA typing will be performed at high resolution (allele level) for the HLA-A, -B, Cw,\n             and DRBl loci\n\n               -  A minimum genotypic identical haplotype match of 4/8 is required\n\n               -  The donor and recipient must be identical, as determined by high resolution\n                  typing, at least one allele of each of the following genetic loci: HLA-A, HLA-B,\n                  HLA-Cw, and HLA- DRB1\n\n          7. Subjects with adequate organs function as measured by:\n\n               -  Cardiac: Left ventricular ejection fraction at rest must be >45%\n\n               -  Pulmonary: FEV 1, FVC, DLCO (diffusion capacity) > 50% predicted (corrected for\n                  hemoglobin); or O2 saturation > 92% on room air\n\n               -  Hepatic: Direct bilirubin ? 3 x upper limit of normal (ULN), or AST/ALT ? 5 x ULN\n\n               -  Renal: Serum creatinine within normal range for age or creatinine clearance, or\n                  with a recommended GFR ? 50 mL/min/1.73m2\n\n          8. Performance status: Karnofsky ? 80%\n\n        Exclusion Criteria:\n\n        Subjects meeting the following criteria are NOT eligible for the study:\n\n          1. HLA 8/8 allele matched (HLA-A,-B,-Cw,-DRBl) related or unrelated donor able to donate;\n\n          2. Autologous hematopoietic stem cell transplant ? 3 months prior to enrollment;\n\n          3. Prior allogeneic transplantation;\n\n          4. Active CNS involvement by malignant cells (less than 2 months from the conditioning);\n\n          5. Current uncontrolled bacterial, viral or fungal infection (currently taking medication\n             with evidence of progression of clinical symptoms or radiologic findings); the PI is\n             the final arbiter of this criterion;\n\n          6. Positive HIV serology or viral RNA (? Grade III per CTCAE criteria);\n\n          7. Pregnancy (positive serum or urine ?HCG test) or breast-feeding;\n\n          8. Fertile men or women unwilling to use effective forms of birth control or abstinence\n             for a year after transplantation;\n\n          9. Bovine product allergy.\n\n         10. Severe obesity (patient's weight is >/= 1.5x the donor weight).
Patients must have a cord blood unit available which is matched with the patient at 4, 5, or 6/6 human leukocyte antigen (HLA) class I (serological) and II (molecular) antigens
Expression of HLA-A*0201.
ENROLLMENT: Confirmation that a cord blood donor which is matched with the recipient at a 4, 5, or 6/6 human leukocyte antigen (HLA) class I (serological) and HLA class II (molecular) antigens.
DONOR: Minimum requirement: The cord blood (CB) unit must be matched at a minimum at 4/6 HLA-A, B antigens and DRB1 allele with the recipient; therefore, 0-2 mismatches at the A or B or DRB1 loci based on intermediate resolution at HLA-A, B and high resolution allele level typing at HLA- DRB1 are allowed
DONOR: Institutional guidelines for HLA-match may be followed as long as the minimum criteria for HLA-matching as above are met
Availability of a suitable human leukocyte antigen (HLA)-matched related donor
Match-specific criteria:\r\n* HLA mismatched or haploidentical related donors: The donor and recipient must be haploidentical at a minimum of one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1\r\n* Donor-specific anti-HLA antibody testing requirement: Testing for antibodies targeting donor specific HLA antigens at HLA-A, B, C, DRB1, DQ and DP will be completed as per institutional standards\r\n* When more than one donor is available, the donor with the lowest number of HLA allele mismatches will be chosen, unless there is an HLA cross-match incompatibility or a medical reason to select otherwise, in which case donor selection is the responsibility of the principal investigator (PI); in cases where there is more than one donor with the least degree of mismatch, donors will be selected based on the most favorable combination of the factors below
Myelodysplastic syndrome (MDS) with < 5% blasts by morphology and meets at least one of the following:\r\n* Received intensive induction chemotherapy (i.e. 7+3 or mitoxantrone, etoposide, and cytarabine [MEC]) OR\r\n* Progression after 4 cycles of hypomethylating agents \r\n** The donor and recipient must be human leukocyte antigen (HLA) identical for at least one haplotype (using high resolution deoxyribonucleic acid [DNA] based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C, and HLA-DRB1
DONORS: HLA-haploidentical related donor (aged 18 to 75 years) where donor and recipient must be HLA identical for at least one haplotype (using high resolution DNA based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C, and HLA-DRB1
Expression of HLA-A*0201.
Be HLA-A2 positive
Patients must have human leukocyte antigen (HLA)-A2 phenotype
Subjects must be HLA-A2 positive by central lab
HLA typing should be performed at registration, if possible
Patients must have resolved any serious infectious complications related to induction\r\n* NOTE: Patients with an HLA-matched donor and proceeding to transplant will be allowed up to one cycle of consolidation treatment
An eligible HLA-identical donor (either related or unrelated) should be available; in sibling donors, low resolution HLA typing (A,B,DR) will be considered sufficient; in the case of unrelated donors, high-resolution class I and II typing (A, B, C, DRB1 and DQ) should be matched at all 10 loci; donors must be willing and able to undergo peripheral blood progenitor mobilization \r\n* HLA-identical sibling (6/6): the donor must be determined to be an HLA-identical sibling (6/6) by serologic typing for class (A, B) and low resolution molecular typing for class II (DRB1)\r\n* Matched unrelated donor (10/10): high resolution molecular typing at the following loci is required: HLA-A, -B, -C, -DRBL, and –DQB1\r\n* NOTE: for matched donors – will allow select 1 antigen mismatched sibling donors and unrelated donors in accordance with site institutional standard, as long as matched at HLA-A, HLA-B, HLA-C, and DRB1, and with advanced discussion/approval by the Study Chair and the bone marrow transplant (BMT) co-chair
The unrelated UCB donors must be 4-6/6 human leukocyte antigen (HLA)-A, B, DRB1 matched with the recipient (HLA matching using molecular techniques: A and B at antigen level and DRB1 at allele level) and the UCB units must come from (a) qualified UCB bank(s) according to institutional standard operating procedures (SOPs); if the UCB unit is \unlicensed\ (most commonly on the basis of location [e.g., European countries], testing by non-Clinical Laboratory Improvements Amendment (CLIA) approved laboratories, or the UCB was collected before May 25, 2005), the Sponsor will make the final decision on patient eligibility based on the reason why the UCB is unlicensed\r\n* The patient must be free of HLA-specific antibodies for HLA antigens present on matched grafts\r\n* Suitable UCB units or haplo-identical donor available according to the UCB graft selection algorithm
Must have a 7/8 or 8/8 or haploidentical related donor matched at the human leukocyte antigen (HLA)-A, B, C, DRB1 who was evaluated and provided the donor transplant graft
DONOR: Must be the same sibling donor from whom the recipient’s blood and marrow graft was collected for the original allogeneic transplant that is HLA 7/8 or 8/8 or haploidentical matched at the HLA-A, B, C, and DRB1
Available related human leukocyte antigen (HLA)-haploidentical NK cell donor by at least class I serologic typing at the A&B locus
Availability of a 6/6 human leukocyte antigen (HLA) matched sibling defined by class I (HLA –A and B) serologic typing (or higher resolution) and class II (HLA-DRB1) molecular typing
DONOR: Must be 6/6 matched sibling donor as determined by HLA typing
Identification of a HLA-matched hematopoietic cell donor without a history of a disorder that can be transmitted by hematopoietic cells, including but not limited to inflammatory bowel disease, and without nucleotide-binding oligomerization domain containing 2 (NOD2) mutations in the case of a HLA matched sibling
DONORS will be a HLA-identical sibling or HLA-matched unrelated donor; unrelated donors are required to be matched by high resolution allele level typing for HLA-A, B, C and DRB1 and intermediate resolution Sequence Specific Oligonucleotide Probes (SSOP), identifying alleles in groups of related families historically defined as antigens for DQB1; an unrelated donor is considered matched if patient and donor share HLA-A, B, C alleles with identical sequences at exons 2 and 3, DRB1 alleles with identical sequences at exon 2, and DQB1 results that include the same allele groups
Human leukocyte antigen (HLA)-A1, -A2, -A3, or -A31 positive
DONOR: HLA-genotypically or phenotypically 1 to 3 antigen mismatched (at the A, B, DR loci) related donors will be acceptable
Patient is HLA-A2+
Patients with a 5/6 or 6/6 related donor match are eligible or a 7-8/8 human leukocyte antigen (HLA)-A,B,C,DRB1 allele matched unrelated volunteer marrow and/or peripheral blood stem cell (PBSC) donor match
DONOR: Appropriate HLA-match to patient
Available related human leukocyte antigen (HLA)-haploidentical donor (aged 14 to 75 years) with donor/recipient match based on a minimum of intermediate resolution DNA based class I typing of the A&B locus
DONOR: Related donors (sibling, parent, offspring, parent or offspring of an HLA identical sibling)
An 8/8 or 7/8 human leukocyte antigen (HLA)–matched non-syngeneic donor is available and eligible to donate hematopoietic stem cells following institutional guidelines for bone marrow transplant (BMT) procedure; high-resolution HLA typing is required at HLA-A, -B, -C and -DR alleles
Any human leukocyte antigen (HLA) type
Patient has anti-human leukocyte antigen (HLA) antibodies specific for HLA antigens expressed by the HB1.F3.CD NSCs
Patients must express human leukocyte antigen (HLA) -A1+, -A2+, or -A3+ (80% of patients)
DONOR: Human leukocyte antigen (HLA)-identical related donors or
DONOR: Unrelated donors matched for HLA-A, B, C, DRB1, and DQB1 as defined by high resolution deoxyribonucleic acid (DNA) typing; mismatch for one HLA allele is allowed
Availability of a human leukocyte antigen (HLA) matched (6/6) sibling donor or 8/8 matched unrelated donor; Donors with mismatch at HLA-A, HLA-B, HLA-C, and HLA-DR will be reviewed by matched unrelated donor (MUD) committee and allowed if their mismatch with the recipient does not require additional GVHD prophylaxis (other than tacrolimus and sirolimus), donors with mismatch at HLA-DQ or HLA-DPB are eligible; donor evaluation according to City of Hope (COH) standard operating procedure (SOP)
The donor and recipient must have a human leukocyte antigen (HLA)-8/8 allelic match at the HLA-A, -B, -C, and –DRB1; high-resolution typing is required for all alleles; donors will be identified according to the institutional bone marrow transplant (BMT) program clinical practice guidelines, which is available to all University of Michigan BMT protocol team members at the internal website
For patients in remission, there should be no readily available consenting human leukocyte antigen (HLA)-matched related donor who is either matched fully matched or mismatched at only one locus of HLA-A, -B, and DRB1; patients who have active leukemia (refractory or relapsed) may be transplanted on this protocol regardless of availability of a related donor since these patients would not typically be transplanted on standard of care treatment plans
No availability of a readily available HLA-matched volunteer unrelated donor (8 of 8 allele match at HLA-A, -B, -C and -DRB1); patients with unstable disease who are in danger of significant disease progression while waiting to procure volunteer donor cells will be eligible to be treated on this protocol, even if a matched donor is available
Patients will be tested for human leukocyte antigen A0201 (HLA-A0201) as determined by flow cytometry followed by molecular analysis of a peripheral blood specimen; however this result will not be an inclusion criterion
Availability of HLA-matched or unrelated donors; related donors must be 5 or 6/6 antigen matched; unrelated donors must be at least 9/10 allele matched
DONOR: HLA-matched related or unrelated allogeneic donors; genotypically HLA identical twins may serve as stem cell donors; related donors must be 5 or 6/6 antigen matched; unrelated donors must be 9/10 allele matched
HLA-A*0201 positive as determined by deoxyribonucleic acid (DNA) allele-specific polymerase chain reaction (PCR) assay; HLA restriction is not required for cohorts 4 and 5
HLA-A*0201 positive as determined by deoxyribonucleic acid (DNA) allele-specific polymerase chain reaction (PCR) assay\r\n* For cohort 5 after amendment 9 and cohort 6, there is no HLA restriction
Donors: Related donor who is human leukocyte antigen (HLA) genotypically identical at least at one haplotype and may be genotypically or phenotypically identical for serological typing for HLA-A, B, -C, and at the allele level for -DRB1 and -DQB1; related donors must be a match or a single allele mismatch at HLA-A, B, and C (at highest resolution available at the time of donor selection) and matched at DRB1 and DQB1 by deoxyribonucleic acid (DNA) typing
Donors: Unrelated donors who are prospectively:\r\n* Matched for HLA-A, B, C, DRB1 and DQB1 by DNA typing at the highest resolution routinely available at the time of donor selection\r\n* Only a single allele disparity will be allowed for HLA-A, B, or C as defined by high resolution typing (no mismatching for DRB1 or DQB1 is allowed)
Consenting first degree relative matched at 6/6 human leukocyte antigen (HLA) antigens (A, B, and DR)
Availability of a suitable matched related (6/6 or 5/6) or unrelated donor (10/10 or 9/10 antigen or allele matched)
Lack of a suitable human leukocyte antigen (HLA)-matched related donor
Patients must have a first-degree related donor or half-sibling who is at minimum HLA haploidentical to be enrolled; the donor and recipient must be identical at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1; a minimum match of 5/10 is therefore required, and will be considered sufficient evidence that the donor and recipient share one HLA haplotype
Positive leukocytotoxic crossmatch; specifically, complement dependent cytotoxicity and flow cytometric crossmatch assays must be negative, and the mean (or median) fluorescence intensity (MFI) of any anti-donor HLA antibody by solid phase immunoassay should be < 2000; if a screening assay against pooled HLA antigens is used, positive results must be followed with specificity testing using a single antigen assay; the MFI must be < 2000 unless the laboratory has validated higher threshold values for reactivity for HLA antigens, such as HLA-C, DQ, and DP, that may be enhanced in concentration on the single antigen assays; consult with principal investigator (PI) for the clinical significance of any anti-donor antibody
Lack of suitable conventional donor (HLA identical sibling or HLA phenotypically identical relative or 10/10 unrelated donor evaluated using high resolution molecular typing) or presence of rapidly progressive disease not permitting time to identify an unrelated donor
The donor and recipient must be identical, as determined by high resolution typing, on at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA- DRB1 and HLA-DQB1.
Acute GVHD developing after allogeneic hematopoietic cell transplantation using either bone marrow, peripheral blood, or umbilical cord blood. Recipients of non-myeloablative, reduced intensity conditioning and myeloablative transplants are eligible. All allogeneic donor sources are permitted, including siblings, unrelated donors, human leukocyte antigen (HLA)-haploidentical related donors and umbilical cord blood.
Lack of 6/6 or 5/6 human leukocyte antigen (HLA)-matched related, 8/8 HLA-matched unrelated donor, or unrelated donor not available within a time frame necessary to perform a potentially curative stem cell transplant
An human leukocyte antigen (HLA)-identical related or an HLA-matched unrelated donor (Fred Hutchinson Cancer Research Center [FHCRC] matching allowed will be Grade 1.0 to 2.1) is available
Matched Related Donor: Related to the patient and is genotypically or phenotypically HLA-identical
Unrelated Donor: FHCRC matching allowed will be grades 1.0 to 2.1: Unrelated donors who are prospectively:\r\n1) Matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing;\r\n2) Only a single allele disparity will be allowed for HLA-A, B, or C as defined by high resolution typing
HLA Matched Related Donor: G-CSF mobilized peripheral blood mononuclear cell (PBMC) only will be permitted as a hematopoietic stem cell (HSC) source on this protocol
A preliminary search has identified:\r\n* An appropriate minimum 4/6 matched umbilical cord unit at intermediate resolution at human leukocyte antigen (HLA)-A and B, and high resolution at HLA-DRB with a cell dose above 1 x 10(7) total nucleated cell (TNC)/kg for a single umbilical cord blood (UCB) transplant AND\r\n* At least one potential 8/8 HLA-matched (HLA-A, -B, -C, and –DRB1) unrelated donor with a probability of 70% AND\r\n* Availability of a potential related haploidentical donor
Known HLA matched related donor without contraindications to donate
Subject must be HLA-A*02:01, HLA-A*02:05 and/or HLA-A*02:06 positive.
Patients must have two partially HLA-matched CBUs
HLA-matched donor able to donate
HLA-identical related or HLA-matched unrelated donor available
DONOR: FHCRC matching allowed will be grade 1.0 to 2.1: unrelated donors who are prospectively: matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing; only a single allele disparity will be allowed for HLA-A, B, or C as defined by high resolution typing
DONOR: Human leukocyte antigen (HLA) identical to recipient subject
DONOR: Donors must be human leukocyte antigen (HLA)-haploidentical first-degree relatives of the patient; eligible donors include biological parents, siblings or half-siblings, or children
DONOR: HLA-haploidentical donor/recipient match by at least class I serologic typing at the HLA-A and B loci
Patients must have a cord blood (CB) unit available which is matched with the patient at 3, 4, 5, or 6/6 human leukocyte antigen (HLA) class I (serological) and II (molecular) antigens
Human leukocyte antigen (HLA)-A*0201 (HLA-A2.1) positivity by molecular subtyping
Available HLA-haploidentical donor that meets the following criteria:\r\n* Blood-related family member (sibling [full or half], offspring, parent, cousin, niece or nephew, aunt or uncle, or grandparent) \r\n* At least 18 years of age\r\n* HLA-haploidentical donor/recipient match by at least low-resolution typing per institutional standards\r\n* In the investigator’s opinion, is in general good health, and medically able to tolerate leukapheresis required for harvesting hematopoietic stem cells (HSC)\r\n* No active hepatitis\r\n* Negative for human T-lymphotropic virus (HTLV) and human immunodeficiency virus (HIV)\r\n* Not pregnant\r\n* NOTE: The HLA-matched sibling and HLA-matched unrelated donor cohorts are closed to enrollment
Patients must have a human leukocyte antigen (HLA)?matched related donor or an unrelated donor who meets standard Seattle Cancer Care Alliance (SCCA) and or National Marrow Donor Program (NMDP) or other donor center criteria for peripheral blood stem cell (PBSC) donation, or bone marrow donation as follows:\r\n* Related donor related to the patient and genotypically or phenotypically identical for HLA-A, B, C, DRB1 and DQB1; phenotypic identity must be confirmed by high-resolution typing\r\n* Unrelated donor: \r\n** Matched for HLA?A, B, C, DRB1 DQB1 by high resolution typing; OR\r\n** Mismatched for a single allele without antigen mismatching at HLA?A, B, or C as defined by high resolution typing but otherwise matched for HLA?A, B, C, DRB1 and DQB1 by high resolution typing\r\n** Patient and donor pairs homozygous at a mismatched allele, in the graft rejection vector are considered a two?allele mismatch, i.e., the patient is A*0101 and the donor is A*0102, and this type of mismatch is not allowed\r\n* Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment; this determination is based on the standard practice of the individual institution; the recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain panel reactive antibody (PRA) screens to class I and class II antigens for all patients before HCT; if the PRA shows > 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained; the donor should be excluded if any of the cytotoxic cross match assays are positive; for those patients with an HLA Class I allele mismatch, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results; a positive anti?donor cytotoxic crossmatch is an absolute donor exclusion
Human leukocyte antigen (HLA)-A*0201 (HLA-A2.1) positivity by molecular subtyping\r\n* Patients with HLA-A*0205 (HLA-A2.5) positivity by molecular subtyping may be eligible if there is demonstration that they can correctly present the MART-1 26-35 epitope as stimulators for interferon (IFN)-gamma production by MART-1 F5 TCR transgenic cells
Partially HLA-mismatched unrelated donor: HLA typing will be performed at high resolution (allele level) for the HLA-A, -B, -C, and -DRB1 loci; a minimum match of 4/8 at HLA-A, -B, -C, and -DRB1 is required
HLA-matched related or 8/8 allele matched (HLA-A, -B, -C, -DRB1) unrelated donor available. This exclusion does not apply to HIV-positive subjects who have a CCR5delta32 homozygous donor.
Have 8/8 allele-level, related or unrelated, medically cleared HSC donor matching at human leukocyte antigen (HLA)-A, HLA-B, HLA-C, and DRB-1
Human leukocyte antigen (HLA)-A2 positive
Presence of a suitable related, HLA-haploidentical or HLA-matched stem cell donor\r\n* The donor and recipient must be identical at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1; a minimum match of 5/10 is therefore required for related donors, and will be considered sufficient evidence that the donor and recipient share one HLA haplotype
Donors must be either:\r\n* HLA-haploidentical or HLA-identical relatives of the patient based on allele or allele group level typing
Lack of recipient anti-donor HLA antibody\r\n* Note: in some instances, low level, non-cytotoxic HLA specific antibodies may be permissible if they are found to be at a level well below that detectable by flow cytometry; this will be decided on a case-by-case basis by the principal investigator (PI) and one of the immunogenetics directors; pheresis to reduce anti-HLA antibodies is permissible; however eligibility to proceed with the transplant regimen would be contingent upon the success of the desensitization
Expression of human leukocyte antigen (HLA)-A:0201 or HLA-A:2402.
Human leukocyte antigen (HLA)-A*02, HLA-A*03, HLA-A*11 or HLA-A*24 positive patients
Patients must have matched related or matched unrelated donor source OR CB unit(s) available for the primary transplant which is/are matched with the patient at 4, 5, or 6/6 human leukocyte antigen (HLA) class I (serological) and II (molecular) antigens; the cord(s) must contain at least 3 x 10^7 total nucleated cells/Kg recipient body weight (pre-thaw)
ELIGIBILITY FOR TREATMENT ON ARM 1: Patients must express human leukocyte antigen (HLA)-A*0201
Recipients of 7-8/8 human leukocyte antigen (HLA) matched adult donor allogeneic stem cell transplantation with myeloablative or non-myeloablative conditioning regimens
Human leukocyte antigen (HLA)-A2-positive
Recipient of 7-8/8 human leukocyte antigen (HLA)-matched (HLA-A, -B, -C, -DRB1) allogeneic hematopoietic stem cell transplantation or a 4-6/6 HLA-matched umbilical cord blood unit(s)
DONOR: Haploidentical 1st-degree relative as defined by 3/6 or 4/6 HLA-matched at HLA -A, -B, or –DRB1 who is 18-70 years of age
Human leukocyte antigen HLA A2 positive
Subjects should have a potential 3-5/6 HLA-matched related haploidentical donor that will be evaluated for eligibility to provide DLI
DONOR: Adult donors must be must be a HLA 3-5/6 related haploidentical match with the patient and must be capable of providing informed consent
Expression of human leukocyte antigen (HLA)-A2
Patients must have one related donor who is human leukocyte antigen (HLA) mismatched in the GVHD direction at two or more HLA loci
Class I or II antibodies against donor HLA antigens
Patient with a human leukocyte antigen (HLA)-identical (HLA-A, B, C, and ribonucleic acid [RNA] binding motif protein 45 [DRB1] molecularly matched) unrelated donor or related donor capable of donating PBSC
DONOR: HLA-matched unrelated donors (HLA-A, B, C, and DRB1 matched based on high-resolution typing) capable and willing to donate PBSC
DONOR: HLA-matched related donors >= 18 years and capable and willing to donate PBSC
Suitable, 6/6 HLA matched related sibling donor available
DONORS: Matched related or unrelated donor stem cell transplant (SCT) matched at human leukocyte antigen (HLA) A- B, C, and DRB1 by molecular methods; 7 of 8 matched donor acceptable for related donors
HLA-Matched Related and Unrelated Donors: Patients who have an HLA-matched related or unrelated donor are eligible for entry on this protocol; this will include a healthy donor who is genotypically matched at all A, B, C, DRB1 and DQB1 loci, as tested by deoxyribonucleic acid (DNA) analysis
HLA-Mismatched Related and Unrelated Donors: Patients who do not have an HLA-matched donor but have a related or unrelated donor who have one antigen or one allele mismatch at the HLA A, B, C, DRB1 or DQB1 loci; or who have two mismatches, at HLA-DQB1 and at one other locus will be eligible for entry on this protocol
Human leukocyte antigen (HLA)-matched (-A, -B, -C, -DRB1) unrelated donors; or 1-locus HLA-mismatched (-A, -B, -C, -DRB1) related or unrelated donors
Available related donor that is at least an allele level haplotype-match at human leukocyte antigen (HLA)- A, B, C, DRB1 and DPB1 loci (DPB1 matching according to the “permissive – non-permissive” dichotomy as stated by University of Wisconsin [UW] Histocompatibility Laboratory); a minimum match of 5/10 loci is required; an unrelated donor search is not required for a patient to be eligible for this protocol
Patients must NOT have a human leukocyte antigen (HLA)-matched sibling
DONOR: Human leukocyte antigen (HLA) identical sibling donor
Has a suitable human leukocyte antigen (HLA) haploidentical donor available
DONOR: Partially HLA matched family member
DONOR: Human leukocyte antigen (HLA) compatible related or unrelated donor (i.e. a fully matched unmanipulated grafts or 1-2 HLA allele disparate donor for CD34 selected grafts)
Patients must have a histocompatible stem cell donor; a human leukocyte antigen (HLA)-identical related donor or a 8/8 matched unrelated donor
Must be HLA A*0201, HLA-A*0205, and/or HLA-A*0206 positive by high resolution testing.
Patients must have undergone a human leukocyte antigen (HLA) matched (sibling) allogeneic HCT for a hematologic or lymphoid malignancy other than chronic myelogenous leukemia (CML) who have recurrent or persistent disease and are otherwise eligible for donor leukocyte infusions; CML patients with persistent disease after receiving donor lymphocyte infusion of at least 1 x 10^8 cells/kg will be eligible for CD8+ memory T cell infusion
DONOR: Donors must be an HLA matched sibling
The patient has an available NK cell donor who is a HLA haploidentical first-degree (parent, child, or sibling) or second-degree (child of a sibling) relative; minimum testing will be for HLA-A, HLA-B, and HLA-DR with donors matched for 3/6, 4/6 or 5/6 antigens
Histocompatible stem cell donor: patients must have an human leukocyte antigen (HLA) matched related or unrelated donor (HLA A, B, C and DR) willing to donate for allogeneic hematopoietic transplantation; high resolution allele level typing is required for donors other than genotypically identical siblings
Donor/Recipient HLA Matching:
Related donor: must be an 8/8 match at HLA-A, -B, -C, (serologic typing or higher resolution) and -DRB1 (at high resolution using DNA based typing). A 7/8 related donor match is permitted only if an 8/8 unrelated donor cannot be identified.
Unrelated donor: must be a 7/8 or 8/8 match at HLA-A, -B, -C, and -DRB1 (at high resolution using DNA based typing).
A fully human leukocyte antigen (HLA) matched or single antigen/allele mismatched sibling or unrelated donor is available
DONOR: Donors must be HLA-matched or one antigen or allele mismatched
DONOR: Donors must be HLA-matched or one antigen or allele mismatched
Available related human leukocyte antigen (HLA)-haploidentical donor (aged 14-75 years) by at least class I serologic typing at the A & B locus
DONOR: Related donors (sibling, parent, offspring, parent or offspring of an HLA identical sibling)
Available related human leukocyte antigen (HLA)-haploidentical donor by at least class I serologic typing at the A&B locus
The patient must express HLA class I allele HLA-A*0201 for NY-ESO-1/LAGE.
MATCHED RELATED DONOR: Human leukocyte antigen (HLA)-matched related donor, excluding identical twins; donors must be matched at least 7 loci out of 8 at the allele or antigen level excluding antigen DRB1 mismatch
MATCHED UNRELATED DONOR: Unrelated donor matched at HLA-A, B, C, and DR loci by high resolution typing (at 8/8 or 7/8 antigen/allele match) are acceptable donors
Patients must have an human leukocyte antigen (HLA)-identical sibling donor or an HLA-matched unrelated donor who meets standard Seattle Cancer Care Alliance (SCCA) and/or National Marrow Donor Program (NMDP) or other donor center criteria for PBSC or bone marrow donation, as follows: \r\n* Related donor: related to the patient and genotypically or phenotypically identical for HLA-A, B, C, DRB1 and DQB1; phenotypic identity must be confirmed by high-resolution typing\r\n* Unrelated donor:\r\n** Matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing; OR mismatched for a single allele without antigen mismatching at HLA-A, B or C as defined by high resolution typing but otherwise matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing \r\n** Doors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment; this determination is based on the standard practice of the individual institution; the recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain panel reactive antibody (PRA) screens to class I and class II antigens for all patients before hematopoietic cell transplant (HCT); if the PRA shows > 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained; the donor should be excluded if any of the cytotoxic cross match assays are positive; for those patients with and HLA class I allele mismatch, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results; a positive anti-donor cytotoxic crossmatch is an absolute donor exclusion\r\n** Patient and donor pairs homozygous at a mismatched allele in the graft rejection vector are considered a two-allele mismatch; i.e., the patient is A*0101 and the donor is A*0102, and this type of mismatch is not allowed
DONOR: FHCRC matching allowed will be grades 1.0 to 2.1: Unrelated donors who are prospectively:\r\n* Matched for human leukocyte antigen (HLA)-A, B, C, DRB1 and DQB1 by high resolution typing\r\n* Only a single allele disparity will be allowed for HLA-A, B, or C as defined by high resolution typing
DONOR: Patients must have a healthy human leukocyte antigen (HLA) matched or mismatched related or unrelated donor who is willing to receive filgrastim (G-CSF) injections and undergo apheresis for peripheral blood stem cell (PBSC) collection, or undergo a marrow harvesting procedure
HLA-matched related and unrelated donors: \r\n* Patients who have an HLA-matched related or unrelated donor are eligible for entry on this protocol; this will include a healthy donor who is genotypically matched at all A, B, C, DRB1 and DQB1 loci, as tested by deoxyribonucleic acid (DNA) analysis
HLA-mismatched related and unrelated donors: \r\n* Patients who do not have an HLA-matched donor but have a related or unrelated donor who have one antigen or one allele mismatch at the HLA A, B, C, DRB1 or DQB1 loci; or who have two mismatches, at HLA-DQB1 and at one other locus, will be eligible for entry on this protocol
Blood HLA-A2 phenotype
Human leukocyte antigen (HLA)-A2 positive by deoxyribonucleic acid (DNA) sequence analysis (by history or as part of this study); HLA testing can be done at local labs
Related or unrelated donor which is HLA-matched or mismatched in 1 HLA A, B, C, DR, or DQ locus is acceptable (i.e. >= 9/10 matched related or unrelated donor, matched with molecular high-resolution technique per current standard [std.] for bone marrow transplant [BMT] program); cord blood units must match patient at 4, 5, or 6/6 HLA class 1 serological & II molecular antigens with a minimum (min.) of 2 x 10^7 total number of nucleated cells (TNC)/kg recipient weight in the pre-thawed fraction; for patient lacking a matched related or unrelated donor or acceptable cord blood unit(s), a related haploidentical donor (=< 7/8 allele matched at A, B, C, DR loci) may be used
Patients must have a 6/6 HLA-matched related donor who is evaluated and deemed able to provide peripheral blood stem cells (PBSCs) and/or marrow by the transplant team
DONOR: Donor must be 6/6 HLA matched, and related to the patient
Patients for whom HLA-matched unrelated donor search could not be initiated or completed due to insurance reasons, concerns of rapidly progressive disease, and/or discretion of attending physician are eligible for this protocol
DONOR: Related, HLA-haploidentical donors who are identical for one HLA haplotype and mismatched for any number of HLA-A, -B, -C, DRB1 or DQB1 loci of the unshared haplotype
Patients with available HLA-matched related donors
Patients must have a related donor who is identical for one human leukocyte antigen (HLA) haplotype and mismatched at the HLA-A, -B or class II, DR beta 1 (DRB1) loci of the unshared haplotype with the exception of single HLA-A, -B or DRB1 mismatches
DONOR: Related donor who is identical for one HLA haplotype and mismatched at the HLA-A, -B, or DRB1 loci of the unshared haplotype with the exception of single HLA-A, -B, or DRB1 mismatches
No available suitably HLA- matched unrelated donor
DONOR: Volunteer unrelated donor matched at a minimum of seven of eight loci (HLA-A, B, C, DRB1), by high resolution typing (> 7/8 allele match) are acceptable donors \r\n* The preferred donor-recipient pair would be matched at all eight loci (8/8 allele match)\r\n* When an 8/8 allele-matched unrelated donor is not available, a single mismatch at HLA-A, -B, -C, or DRB1 will be acceptable in patients who meet all eligibility criteria and are 18-69 years of age\r\n** In the situation where more than one 7/8 match is available donor recipient pairs matched at HLA-DQ will be used
Availability of appropriate, willing, HLA-matched related marrow donor
DONOR: Related or unrelated human leukocyte antigen (HLA) identical donors who are in good health and have no contra-indication to donation
Patients who have suitable human leukocyte antigen (HLA)-matched related or unrelated donors willing to receive filgrastim (G-CSF), undergo leukapheresis to collect peripheral blood mononuclear cell (PBMC), and to donate stem cells
RELATED DONORS: When more than one potential donor exists, priority should be given to donors based on HLA identity > cytomegalovirus (CMV) seronegativity > ABO compatibility > sex matching\r\n* Donor who is HLA phenotypically or genotypically identical at the allele level at HLA-A, -B, -C, -DRB1, and -DQB1\r\n* Must consent to G-CSF administration and leukapheresis; \r\n* Must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian);\r\n* Only G-CSF mobilized PBMC only will be permitted as a hematopoietic stem cell (HSC) source on this protocol
UNRELATED DONORS: \r\n* Fred Hutchinson Cancer Research Center (FHCRC) matching allowed will be Grades 1.0 to 2.1; Unrelated donors who are prospectively: \r\n* Matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing\r\n* Only a single allele disparity will be allowed for HLA-A, B, or C as defined by high resolution typing
Patients having received a preceding allogeneic transplantation from either a human leukocyte antigen (HLA)-matched related or unrelated donor are eligible for this protocol\r\n* Related donor: HLA genotypically identical at least at one haplotype and may be phenotypically or genotypically identical at the allele level at HLA A, B, C, DRB1, and DQB1\r\n* Unrelated donor who are prospectively:  \r\n** Matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing; OR\r\n** Only a single allele disparity will be allowed for HLA-A, B, or C as defined by high resolution typing
Must have an HLA genotypically or phenotypically identical related donor or, at a minimum, a high likelihood of identifying an HLA-matched unrelated donor; the determination of availability of a suitable unrelated donor may be based on a World-Book search
Cross-over to other tandem autologous-allogeneic research protocol (#2241) will be allowed if the patient loses the suitable HLA-matched related or unrelated donor but has an available HLA-haploidentical donor before receiving the allogeneic transplantation and if the patient meets the eligibility criteria of the subsequent study
Cross-over from other tandem autologous-allogeneic research protocol (#2241) will be allowed if a suitable HLA-matched related or unrelated donor is identified before receiving the allogeneic transplantation and if the patient meets the eligibility criteria of the subsequent study
DONOR: Fred Hutchinson Cancer Research Center (FHCRC) matching allowed will be grades 1.0 to 2.1; unrelated donors who are prospectively: matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing; only a single allele disparity will be allowed for HLA-A, B, or C as defined by high resolution typing
Patients eligible for the study must have a human leukocyte antigen (HLA)-identical sibling or HLA-matched unrelated bone marrow donor available and willing to donate
DONOR: HLA genotypically identical sibling or unrelated donor; unrelated donors are required to be matched by standard molecular methods at the intermediate resolution level at HLA-A, B, C and DRB1 and the allele level at DQB1
Donor is blood-related and human leukocyte antigen (HLA)-haploidentical to the recipient
Available human leukocyte antigen (HLA)-matched or -haploidentical, living related donor who is willing to donate bone marrow and part of liver; the donor and recipient must be HLA identical for at least one allele (using high resolution deoxyribonucleic acid [DNA] based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C and HLA-DRB1; fulfillment of this criterion shall be considered sufficient evidence that the donor and recipient share one HLA haplotype
No donor-specific antibodies (DSA) using solid phase micro particle technology (by Luminex phenotype panel or Luminex single antigen bead test) performed 30 days or less prior to transplant; as assessed by local laboratories; a positive anti-donor HLA antibody test is defined as the presence of an antibody against any one of the high expression HLA molecules (HLA-A, -B, -C, or –DRB1) with a mean fluorescence intensity (MFI) > 1000 by solid phase immunoassay
DONOR: HLA-matched or -haploidentical, parent, child, sibling, or half-sibling of the recipient
Anti-donor HLA antibody using solid phase micro particle technology (by Luminex phenotype panel or Luminex single antigen bead test) performed 30 days or less prior to transplant as assessed by local laboratories; the director of the immunogenetics laboratory will be responsible for determining what level of antibody is considered a positive anti-donor HLA antibody result
HLA-A02*:01 positive
For Pre-allo Part A (before stem cell transplant): Availability of an HLA matched related or unrelated donor
Patients must have a related donor who is a two or more allele mismatch at the human leukocyte antigen (HLA)-A; B; C; DR and DQ loci; patients who have sibling donors with a one antigen mismatch due to recombination will not be enrolled in this protocol
Lack of 5 6/6 HLA matched related or 8/8 HLA A, B, C, DRß1 matched unrelated donor; or unrelated donor not available within appropriate timeframe, as determined by the transplant physician.
HLA-matched related donor able to donate.
Patient must have a partially (>= 3/6 class I antigen) human leukocyte antigen (HLA)-matched (by serology or low resolution deoxyribonucleic acid [DNA] testing) relative able to serve as a donor
DONOR: donor must be related to patient and be partially (>= 3/6 antigen) HLA-matched
DONOR: Donors will be selected to minimize human leukocyte antigen (HLA) mismatch in the host-versus-graft direction
Patients must be human leukocyte antigen (HLA)-A*0201 positive
Patients must have one of the following donor types identified who are willing to donate peripheral blood:\r\n* Related donor, 8/8 human leukocyte antigen (HLA)-matched for HLA-A, -B, C and DR matched or\r\n* Matched unrelated donor (MUD), 8/8 HLA-matched for HLA A, B, C and DRB1 using allele level typing
Available peptide-MHC pair that can be folded into a tetramer for which MCPyV TAg-specific cells can be generated and reactivity to cell lines expressing MCPyV TAg with the corresponding human leukocyte antigen (HLA)
Available related human leukocyte antigen (HLA) haploidentical NK cell donor by at least Class I serologic typing at the A and B locus (age 12-75 years)
DONOR: Related donors (sibling, parent, offspring, parent or offspring of an HLA identical sibling) age 12 to 75 years
DONOR: HLA-haploidentical donor/recipient match; if time permits and multiple donors are available, preference will be given to the KIR ligand mismatched donor (as predicted by HLA typing)
Patients must have one or two partially HLA-matched CBUs
HLA-matched donor able to donate
A 10/10 HLA matched (high resolution typing at A, B, C, DRB1, DQ1) sibling or unrelated donor.
Human leukocyte antigen (HLA)-A*02+ by serology by an ASHI accredited laboratory;
Has a potentially suitable human leukocyte antigen (HLA) haploidentical donor available
Has a confirmed suitable HLA haploidentical donor available
DONOR: Partially HLA matched family member
Patient must qualify with a study specific HLA typing assay.
Patient must be HLA-A*0201+ and/or HLA-A*0206+
Patients must be human leukocyte antigen (HLA) A2 positive by polymerase chain reaction (PCR) typing
Human leukocyte antigen (HLA) type A0201 or A2402
Patients must be human leukocyte antigen (HLA)-A*02:01-positive
Has a suitable partially human leukocyte antigen (HLA)-matched (>= 3 of 6) family member donor
Human leukocyte antigen (HLA)-A2 positive.
Recipient of a first renal allograft from a human leukocyte antigen (HLA)-haploidentical, living related donor; the donor and recipient must be HLA identical for at least one allele (using high resolution deoxyribonucleic acid [DNA] based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C, and HLA-DRB1; fulfillment of this criterion shall be considered sufficient evidence that the donor and recipient share one HLA haplotype
DONOR: HLA-haploidentical, first-degree relatives or half-siblings of the recipient participant at the allele or allele group; the donor and recipient must be HLA identical for at least one allele (using high resolution DNA based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C and HLA-DRB1; fulfillment of this criterion shall be considered sufficient evidence that the donor and recipient share one HLA haplotype
Patients must have an available 8/8 human leukocyte antigen (HLA)-A, -B, -C, and -DRB1 matched-related or unrelated donor allogeneic hematopoietic peripheral blood stem cell graft
DONOR: Eligible donors include healthy sibling, relative or unrelated donors that are matched with the patient at HLA-A, B, C, and DRB1 by high resolution typing
No more than 1 antigen mismatch at Human Leukocyte Antigen (HLA)-A, -B, -C, -DRB1 or -DQB1 locus for either related or unrelated donor; and
Availability of appropriate partially HLA-matched and restricted tabelecleucel cell product
Has a suitable human leukocyte antigen (HLA) partially matched family member donor (HLA identical or phenotypically matched 8/8 family member donors will not be used on this protocol)
Donor must be a 6/6 HLA-matched sibling willing to donate PBSC for transplant.
Recipient must have a 6/6 HLA-matched sibling willing to donate PBSC for transplant.
Presence of a suitable first-degree related, HLA-haploidentical or HLA-matched bone marrow donor;\r\n* The donor and recipient must be identical at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1; a minimum match of 5/10 is therefore required, and will be considered sufficient evidence that the donor and recipient share one HLA haplotype
DONOR: Donors must be HLA-haploidentical or HLA-identical, first-degree relatives of the patient based on allele or allele group level typing; half-siblings are not permitted
DONOR; Lack of recipient anti-donor HLA antibody\r\n* Note: In some instances, low level, non-cytotoxic HLA specific antibodies may be permissible if they are found to be at a level well below that detectable by flow cytometry; this will be decided on a case-by-case basis by the PI and one of the immunogenetics directors; pheresis to reduce anti-HLA antibodies is permissible; however eligibility to proceed with the transplant regimen would be contingent upon the success of the desensitization
Subjects with who have undergone a non-myeloablative allogeneic transplant, using a 3-6/6 HLA matched related donor
Patients must have a related, genotypically human leukocyte antigen (HLA) identical donor, or they must have a unrelated donor who is 8/8 HLA match by high resolution typing
Must have consenting sibling matched at 6/6 human leukocyte antigen (HLA) antigens (A, B, DR)
DONOR: Sibling who is 6/6 HLA-matched with recipient
Patients must have an human leukocyte antigen (HLA)-compatible related or unrelated donor (one-antigen mismatched related donors are acceptable) willing to donate marrow or recombinant human-granulocyte colony-stimulating factor [rhG-CSF] mobilized peripheral blood stem cells; in the event of transplants from matched unrelated donors, a high-resolution allele match for HLA-A, -B, -C, -DRB1 (\8 of 8 match\) is required
Patient must have an available unrelated donor with a 7/8 or 8/8 match for HLA-A, B, C, and DRB1 antigen; typing is by DNA techniques: intermediate resolution for A, B, and C, and high resolution for DRB1; HLA-DQ typing is recommended but will not count in the match
Positive patient anti-donor lymphocyte crossmatch in HLA-A or B mismatched transplants; the definition of match is in Section 2.2.1; the crossmatch would only apply to mismatches at HLA-A or B, not DRB1 or HLA-C
Any human leukocyte antigen (HLA) type (historic HLA typing is permitted)
Must have an human leukocyte antigen (HLA)-matched sibling, HLA-matched unrelated donor, or a related haploidentical donor:\r\n* Available HLA-matched sibling or unrelated donor must meet the following criteria:\r\n** At least 18 years of age\r\n** HLA donor/recipient match based on at least low-resolution typing per institutional standards (syngeneic donors [identical twins] are excluded)\r\n** In the investigator’s opinion, is in general good health, and medically able to tolerate leukapheresis required for harvesting stem cells\r\n** No active hepatitis\r\n** Negative for human T-cell lymphotropic virus (HTLV) and human immunodeficiency virus (HIV)\r\n** Not pregnant OR\r\n* Available haploidentical donor must meet the following criteria:\r\n** Blood-related family member (sibling [full or half], offspring, parent, cousin, niece or nephew, aunt or uncle, or grandparent)\r\n** At least 18 years of age\r\n** HLA-haploidentical donor/recipient match by at least low-resolution typing per institutional standards\r\n** In the investigator’s opinion, is in general good health, and medically able to tolerate leukapheresis required for harvesting stem cells\r\n** No active hepatitis\r\n** Negative for HTLV and HIV\r\n** Not pregnant
Patients must be human leukocyte antigen (HLA)-A*0201 positive
Human leukocyte antigen (HLA)-A0201 or HLA-A2402
Plan to receive an allogenic transplant from a 4-6/6 single or dual umbilical cord blood graft, or a 7-8/8 human leukocyte antigen (HLA)-matched sibling or unrelated donor (high resolution HLA-A, B, C, DRB1)
Patient’s donor must be a related or unrelated human leukocyte antigen (HLA) 8/8 allele-level match (HLA-A, B, C and DRB1)
Subject must be HLA A*02:01, HLA A*02:05 and/or HLA-A*02:06 positive.
DONOR: Human leukocyte antigen (HLA) >= 7/8 related or unrelated donors
Eligible patients will have one of the following sources of donor stem cells:\r\n* Human leukocyte antigen (HLA) matched family member\r\n* Partially matched family member (mismatched for a single HLA locus at A, B, C or DR)\r\n* Fully HLA matched or partially mismatched unrelated marrow or peripheral blood stem cells (per institutional donor selection standards)\r\n* HLA matched or partially mismatched (at least 4/6 match at A, B, DR) cord blood
Related donor of T cells must be at least partially human leukocyte antigen (HLA) compatible, matching with recipient in at least 3/6 HLA loci (HLA-A, HLA-B, and HLA-DRB1 loci will be considered for this)\r\n* Donor selection priority: The original donor will be the first choice as source of T cells; If the original donor is unavailable for donation of peripheral mononuclear cells or does not meet all donor eligibility criteria, alternative related donors will be selected, with preference for those who have full HLA matching in 6/6 loci over those with partial HLA matching (>= 3/6 HLA loci)
Presence of a suitable related, HLA?haploidentical or HLA?matched stem cell donor or unrelated matched donor\r\n* The donor and recipient must be identical at least one allele of each of the following genetic loci: HLA?A, HLA?B, HLA?Cw, HLA?DRB1, and HLA?DQB1; a minimum match of 5/10 is therefore required for related donors, and will be considered sufficient evidence that the donor and recipient share one HLA haplotype; unrelated donors will be 10/10
DONOR: donors must be either:\r\n* HLA?haploidentical or HLA?identical relatives of the patient based on allele or allele group level typing\r\n* Unrelated donor who is a 10/10 match to the recipient
DONOR: lack of recipient anti?donor HLA antibody\r\n* Note: in some instances, low level, non?cytotoxic HLA specific antibodies may be permissible if they are found to be at a level well below that detectable by flow cytometry; this will be decided on a case?by?case basis by the principal investigator (PI) and one of the immunogenetics directors; pheresis to reduce anti?HLA antibodies is permissible; however eligibility to proceed with the transplant regimen would be contingent upon the success of the desensitization
Patient has a suitable and willing HLA-8/8 matched or 7/8 mismatched (at one allele) unrelated donor identified
Eligible participants will only be transplanted for standard clinical indications, which include hematologic malignancies such as acute leukemia, high risk lymphoma, and multiple myeloma; much less commonly there are non-malignant indications for transplants; these include aplastic anemia and severe hemoglobinopathies; no patients will be transplanted for the primary purpose of HIV eradication; patients will undergo one of the following types of transplant:\r\n* Myeloablative, human leukocyte antigen (HLA) matched or partially HLA-mismatched (haploidentical), alloHSCT that includes high-dose post-transplantation cyclophosphamide (Cy)\r\n* Nonmyeloablative, HLA matched or partially HLA-mismatched, alloHSCT that includes high-dose post-transplantation Cy
Patients must be undergoing allogeneic hematopoietic stem cell transplantation (alloHCT) for hematologic malignancies from matched related or matched unrelated donors with 8/8 (A, B, C, DRB 1) high resolution human leukocyte antigen (HLA) donor allele matching
Planned related HCT with molecular 3/6 (haploidentical) intermediate/high resolution human leukocyte antigen (HLA) donor allele matching
HLA A*0201 high resolution, 4-digit type is required at HLA-A2 to ensure A*0201 status
Planned related or unrelated HCT, with HLA donor allele matching; related donor must be an 8/8 match for HLA-A, -B, and -C at intermediate (or higher) resolution, and -DRB1 at high resolution using deoxyribonucleic acid (DNA)-based typing; unrelated donor must be an 8/8 match at HLA-A, -B, -C, and -DRB1 at high resolution using DNA-based typing; patients undergoing a second allogeneic (allo) HCT are not eligible (patients who have undergone a previous autologous HCT are eligible)
Planned related or unrelated HCT, with 8/8 (A, B, C, DRB1) high/intermediate resolution HLA donor allele matching
Availability of a willing and suitable human leukocyte antigen (HLA) identical related donor
Presence of antibodies to a mismatched donor HLA antigen
DONOR: Must be the same sibling donor from whom the recipient’s blood and marrow graft was collected for the original allogeneic transplant that is human leukocyte antigen (HLA) 7/8 or 8/8 matched at the HLA-A, B,C, DRB1
Recipient of 7-8/8 human leukocyte antigen (HLA)-matched (HLA-A, -B, -C, -DRB1) allogeneic hematopoietic stem cell transplantation
Patient must be the recipient of unrelated donor peripheral blood stem cell products; mismatches at both antigen and allele level will be eligible; match must be 6, 7, or 8 out of 8 loci (human leukocyte antigen [HLA] A, B, C and DRB1)
Human leukocyte antigen (HLA)-identical sibling donor
DONOR: HLA genotypically identical sibling
Patients transplanted from related or unrelated, human leukocyte antigen (HLA)-matched or mismatched donors
All candidates for this study must have a human leukocyte antigen (HLA) (A, B, C, DR) identical siblings who is willing to donate bone marrow or primed blood stem cells or an 8/8 allele-matched unrelated donor
Each UCB unit must be matched at 4-6 human leukocyte antigen (HLA)-A, B, DRB1 antigens with the recipient; this may include 0-2 antigen mismatches at the A or B or DRB1 loci; each unit must be a 4-6 HLA-A, B, DRB1 antigen match to each other, not necessarily at the same loci they are matched to the recipient
Related donor must be an 8/8 match for human leukocyte antigen (HLA)-A, -B, and -C at intermediate (or higher) resolution, and -DRB1 at high resolution using DNA-based typing. Pediatric related donors must weigh ? 25.0 kg., must have adequate peripheral venous catheter access for leukapheresis or must agree to placement of a central catheter, must be willing to (1) donate bone marrow and (2) receive G-CSF followed by donation of peripheral blood stem cells (product to be determined by randomization post enrollment) and must meet institutional criteria for donation.
Availability of a suitable 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated mPB donor;
HLA-A2+ or HLA-A3+ or HLA-A24+ or HLA-A26+
Patients must have received transplantation from donors (both related and unrelated) who are identical at 8 HLA loci (A, B, C and DRbeta1), or mismatched at no more than 1 locus (7/8); among related donors, HLA C typing is not required (6/6 HLA matches); class I typing is to be performed by polymerase chain reaction (PCR)-sequence specific primers (SSP) techniques and complement-dependent cytotoxicity (CDC) techniques; class II typing is performed by PCR-restriction fragment length polymorphism (RFLP) +/- PCR-SSP techniques
Participants must be human leukocyte antigen (HLA)-A2 positive
RECIPIENT: Planned related HCT with 6/6 (A, B, C, DRB1) high resolution HLA donor allele matching
Human leukocyte antigen (HLA) identical sibling donor, HLA matched unrelated donor, or donor mismatched at 1 HLA allele or antigen
Presence of human leukocyte antigen (HLA) antibodies
No available human leukocyte antigen (HLA)-matched related donor
7 out of 8 at high resolution using deoxyribonucleic acid (DNA)-based typing with either antigen or allele mismatched HLA (-A, -B, -C, and -DR) or 8/8 HLA-mismatched with either double DQ mismatch (10/12) or combined DQ and DP mismatch
Absence of donor-specific antibodies (DSA) to the mismatched HLA-locus
Recipients of 8-7/8 HLA-matched donor; post-HSCT period within day +100 to day +150
Per Moffitt Cancer Center (MCC) bone marrow transplant (BMT) program practices, an allele level matched (8/8 human leukocyte antigen [HLA] A, B, C and DR) sibling or unrelated donor is preferred; if a matched donor is not found, mismatched unrelated or haploidentical donors may be considered
If a haploidentical donor is considered, parents, children, full siblings and in selected cases, extended family, will have high resolution typing at the MCC HLA laboratory; a familiar haploidentical donor is chosen among those who share at least one HLA-A, B, C, DRB1 and DQB1 haplotype with the patient
Patient will be screened for antibodies targeting mismatched HLA antigens in potential haploidentical donors (donor specific antibodies, DSA); antibody screen and confirmatory testing using Luminex single antigen-bead test will be done
Patients must have an available 8/8 HLA-A, -B, -C, and -DRB1 matched-related or unrelated donor allogeneic hematopoietic peripheral blood stem cell graft
Eligible donors will include healthy sibling, relative or unrelated donors that are matched with the patient at HLA-A, B, C, and DRB1 by high resolution typing as defined by the Collaborative Trials Network
Availability of an human leukocyte antigen (HLA) matched related donor
Human leukocyte antigen (HLA) mismatched related or unrelated donor identified 8/10 or 9/10
Patients receiving allogeneic peripheral blood stem cell (PBSC) grafts from HLA-matched (5/6 and 6/6 matches) siblings or from well matched unrelated donors (9/10 or 10/10 matches at HLA-A, B, C, DRB1 and DQB1 by high resolution typing) are included; all grafts will be unmanipulated (i.e., no T cell depleted or CD34 selected grafts)
Patients must have received transplantation from an human leukocyte antigen (HLA)-matched (6/6 loci at A, B, and DRB1) or mismatched (3-5/6) donor (related or unrelated); class I and II typing is to be performed by standard methods at our institution
Human leukocyte antigen (HLA) matched 8/8 (A, B, C, DRB1) related or unrelated donor
Human leukocyte antigen (HLA) matching:\r\n* HLA typing will be performed by high resolution molecular deoxyribonucleic acid (DNA) typing for HLA class 1 A, B and C, and class II DRB1 and DQB1 alleles
UNRELATED DONOR: an HLA 7/8 or 8/8 HLA A, B and C (class I) and HLA DRB1 (class II) alleles, or 9/10 or 10/10 HLA A, B and C (class I) and HLA DRB1 and DQB1 (class II) alleles will be required for study entry
DONOR: HLA typing will be performed by high resolution molecular DNA typing for HLA class 1 A, B and C, and class II DRB1 and DQB1 alleles
DONOR: unrelated adult donors must be matched by high resolution molecular DNA typing at 7/8 or 8/8 HLA A, B and C (class I) and HLA DRB1 (class II) alleles, or 9/10 or 10/10 HLA A, B and C (class I) and HLA DRB1 and DQB1(class II) alleles
DONOR: related donors must be matched by high resolution molecular DNA typing at 5/10, 6/10, 7/10, 8/10, 9/10 or 10/10 HLA A, B and C (class I) and HLA class II DRB1 and DQB1 alleles
DONOR: Eligible donors will include siblings age >= 18 matched with the recipient at human leukocyte antigen (HLA)-A, B, C, and DRB1\r\n* Donor selection and stem cell product transplantation will be in compliance with 21 Code of Federal Regulation (CFR) 1271
Availability of human leukocyte antigen (HLA)-identical sibling donor
DONOR: HLA genotypically identical sibling
Planned recipient of a first kidney allograft from an HLA-matched, living related donor
Baseline positive donor-specific anti-HLA antibody testing
Hematopoietic cell transplant (HCT)\r\n* No previous history of HCT or other cellular therapy (e.g., chimeric antigen receptor [CAR]-T cells, donor lymphocyte infusions)\r\n* Patient must be receiving cells from a first alternative donor defined as one of the following:\r\n** Unrelated donor with a complete human leukocyte antigen (HLA) match or a 1 or 2 HLA mismatch\r\n** Related donor with a 1 or 2 HLA mismatch
Patient plans on receiving stem cells from a donor who has a 3 or more HLA mismatch
Availability of a related haploidentical donor with ? 4/8 but < 7/8, or ? 5/10 but < 9/10 matches at the HLA-A, -B, -C, -DRB1, and/or -DQB1 loci, as determined by high resolution human leukocyte antigen (HLA)-typing
Availability of a suitable HLA-matched sibling or unrelated donor in a donor search
Known presence of HLA antibodies against the non-shared donor haplotype
Known presence of HLA antibodies against the non-shared donor haplotype
Haploidentical family donor with 2 to 3 mismatches at the HLA-A, -B and/or -DR loci of the unshared haplotype
Available human leukocyte antigen (HLA)-haploidentical donor that meets the following criteria:\r\n* Immediate family member (sibling, offspring, or parent)\r\n* HLA-haploidentical donor/recipient match by class I serologic typing at the A&B locus\r\n* In the treating physician’s opinion, is in general good health, and medically able to tolerate leukapheresis required for harvesting hematopoietic stem cells (HSC)\r\n* No active hepatitis (B, C), human T-cell lymphotropic virus (HTLV), and human immunodeficiency virus (HIV) infections\r\n* Not pregnant
HLA typing will be performed at high resolution (allele level) for the HLA-A, -B, Cw, and DRBl, and loci. A minimum match of 5/10 is required. The donor and recipient must be identical, as determined by high resolution typing, at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, and HLA- DRB1.
HLA-matched, related or 7-or 8/8 allele matched (HLA-A,-B,-Cw,-DRBl) unrelated donor able to donate.
HLA-A*02:01, HLA-A*02:05, and/or HLA-A*02:06 by high resolution testing at a local or central laboratory
Patients must have a related or unrelated peripheral blood stem cell donor; sibling donor must be a 6/6 match for human leukocyte antigen (HLA)-A and -B at intermediate (or higher) resolution, and -DRB1 at high resolution using deoxyribonucleic acid (DNA)-based typing, and must be willing to donate peripheral blood stem cells and meet institutional criteria for donation; unrelated donor must be 8/8 match at HLA-A, -B, -C and –DRB1 at high resolution using DNA-based typing; unrelated donor must be willing to donate peripheral blood stem cells and be medically eligible to donate stem cells according to National Marrow Donor Program (NMDP) criteria
Sibling donor must be a 6/6 match for HLA-A and -B at intermediate (or higher) resolution, and -DRB1 at high resolution using DNA-based typing, and must be willing to donate peripheral blood stem cells and meet institutional criteria for donation.
Patients must be HLA-A2 positive
HLA-A2 negative patients
HLA-A2 or HLA-A3 haplotype
For patients at high risk for developing aGVHD only: Recipients of myeloablative or reduced intensity allogeneic transplants using either bone marrow or peripheral blood stem cells from HLA-matched or HLA-mismatched related or unrelated donors (protocols 9142, 9022, 9924) who have not yet been placed on any therapy for acute GVHD.
HLA-DPB1*04:01 positive
Positive for HLA-A*02:01or HLA-A*02:642 allele.
Positive for any of the HLA-A*02 allele other than HLA-A*02:01 or HLA-A*02:642 or the following alleles: HLA-A*02:02, HLA-C*04:04 or HLA-B*51:03.
The patient has a human leukocyte antigen (HLA)-matched donor and is eligible for allogeneic transplantation for CML treatment.