Matched sibling, cord blood and haploidentical donors are not eligible.
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
Suitably HLA-matched related or unrelated donors
HEALTHY BONE MARROW DONORS: Healthy individuals, ages >= 4 years and toilet-trained, who have been identified by Boston Children's Hospital (BCH) or Dana Farber Cancer Institute (DFCI) providers as 9/10 or 10/10 (HLA-A, -B, -C, -DRB1, -DQB1) matched, bone marrow donors for transplantation will also be eligible to participate in this study; healthy donors may be related or unrelated to the bone marrow recipient
HLA-matched related donors >= 18 years and capable and willing to donate PBSC (Arms A and B)
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
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
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
DONOR: HLA-haploidentical first-degree relatives of the patient, including biological parents, siblings, or children, or half-siblings
5/6 or 6/6 related donor match or a 7-8/8 HLA-A, B, C, DRB1 allele matched unrelated donor marrow and/or PBSC donor match per current institutional guidelines; related donors will be evaluated and collected per MT2012-14C; unrelated donors will be identified and collected per usual procedures
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
8/8 HLA MATCHED UNRELATED DONORS
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: Donors must be HLA-haploidentical first-degree relatives of the patient; eligible donors include biological parents, siblings, or children, or half-siblings
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
DONOR: Donors will be pre-selected on the basis of HLA haploidentity
DONOR: Donors must be HLA-haploidentical first-degree relatives of the patient; eligible donors include biological parents, siblings, or children, or half-siblings
Donors will be pre-selected on the basis of HLA haploidentity
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
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-matched related donors >= 18 years and capable and willing to donate PBSC
The clinical trial will be offered to all high risk (defined below) patients with hematologic malignancies who require stem cell transplants as part of their standard of care using matched related or unrelated donors
Human leukocyte antigen (HLA)-matched (-A, -B, -C, -DRB1) unrelated donors; or 1-locus HLA-mismatched (-A, -B, -C, -DRB1) related or unrelated donors
DONOR: Donors must be at least HLA-haploidentical first degree relatives of the patients; eligible donors include biological parents, siblings, half-siblings or children
DONOR: Donors must be HLA-matched or one antigen or allele mismatched
DONOR: Donors must be HLA-matched or one antigen or allele mismatched
MATCHED RELATED DONOR: Donors receiving experimental therapy or investigational agents
Patients with available HLA-matched related donors
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
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
Must have a willing unrelated adult donor (bone marrow or peripheral blood); donors may have a single mismatch (i.e. be a 7/8) and this mismatch may be at the allele or antigen level; however, donors with allele level disparity should be given preference over those with antigen level disparity; the use of mismatched donors in which disparity is only in the host versus graft direction (because of recipient homozygosity) is discouraged because of the potentially heightened risk for graft rejection; centers may perform extended typing (e.g. DQB1 and DPB1) according to institutional practices and use these results in selecting donors; however, it is recommended that this extending typing be used only to select between donors who are equally well matched with the recipient at the A, B, C and DRB1
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
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)
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.
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)
DONOR: HLA-matching must be based on results of high resolution typing at HLA-A, –B, -C, -DRB1, and –DQB
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.
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 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.
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).
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
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)
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)
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: 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
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.
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: HLA-matching must be based on results of high resolution typing at HLA-A, –B, -C, - DRB1, and –DQ
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
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
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: 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
DONOR: HLA typing per University of Alabama (UAB) standard
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
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
An 8/8 human leukocyte antigen (HLA) matched (high resolution typing at A, B, C, DRB1) sibling or unrelated donor
DONOR: Donor's high resolution human leukocyte antigen (HLA) typing must be available for review
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
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
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
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 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
DONOR: all matching will be performed at the allele level, with high resolution typing
Must be HLA compatible in 10/10 or 9/10 alleles by 4 digit/allele high-resolution molecular genotyping
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
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)
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
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
HLA typing should be performed at registration, if possible
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
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
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
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
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
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
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)
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
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
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
An adequate graft for the defined donor type\r\n* Haplo-cord requires a haploidentical adult donor of 14 years of age and at least 50 kg, and a cord blood unit with at least 1.0 x 10(7) TNC/kg and a match of at least 4/6 by intermediate resolution for HLA-A and B and high resolution at DRB1; donor provides standard of care consent for harvest following institutional policy; any donor samples or donor research data would be obtained on separate donor research protocol\r\n* For MUD requires a 7/8 or 8/8 HLA matched unrelated donor with high resolution matching at HLA-A, -B, -C, and DRB1; DP matching or DP permissive should be achieved when possible using T-cell epitope strategy
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: HLA-matched unrelated donors (HLA-A, B, C, and DRB1 matched based on high-resolution typing) capable and willing to donate PBSC
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
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
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
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
A 10/10 HLA matched (high resolution typing at A, B, C, DRB1, DQ1) sibling or unrelated donor.
Patient must qualify with a study specific HLA typing assay.
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
Planned related HCT with molecular 3/6 (haploidentical) intermediate/high resolution human leukocyte antigen (HLA) donor allele matching
Planned related or unrelated HCT, with 8/8 (A, B, C, DRB1) high/intermediate resolution HLA donor allele matching
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
RECIPIENT: Planned related HCT with 6/6 (A, B, C, DRB1) high resolution HLA donor allele matching
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
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
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
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
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
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
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
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
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
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
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
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
Patient with no matched related donor who has a related haploidentical donor identified (=< 7/8 allele match at the A, B, C, DR loci) who is willing to undergo a bone marrow harvest and an NK cell collection approximately 2 weeks of the recipient's admission for transplant; the donor must be 16 years of age or older and weigh at least 110 pounds
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
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
Must have matched unrelated donor (8 of 8 HLA match at A, B, C, and DR loci) by high resolution deoxyribonucleic acid (DNA) typing
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
DONOR: HLA-genotypically or phenotypically 1 to 3 antigen mismatched (at the A, B, DR loci) related donors will be acceptable
Recipient of mismatched (allele or antigen level) graft in more than one loci of HLAA, -B, -C or –DR loci will not be eligible, i.e. recipients of 2-antigen or 2-allelele mismatched graft
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
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
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
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
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
Patients of Dr. Gonzalez
Medical clearance by Dr. Murphy
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
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
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
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).
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
The patient must have an available sibling or matched unrelated donor with at least a 7/8 human leukocyte antigen (HLA) match
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.
DONOR: Human leukocyte antigen (HLA) haplo-identical matched related.
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);
Use of mobilized peripheral blood stem cells from fully human leukocyte antigen (HLA)-matched related or unrelated donor as a graft source
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.
Lack of a human leukocyte antigen (HLA) matched related donor, lack of an immediately available 8/8 HLA matched unrelated donor
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
No more than 1 antigen mismatch at human leukocyte antigen (HLA)-A, B, C, DRB1 and DQB1 locus for either related or unrelated donor
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
The recipient must have a related donor genotypically human leukocyte antigen (HLA)-A, B,C and DRB1 loci haploidentical to the recipient
Has a human leukocyte antigen (HLA)-matched or single allele-mismatched adult sibling serving as donor
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)
DONOR: Human leukocyte antigen (HLA)-matched or 1 antigen mismatched sibling donor
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
No available suitable human leukocyte antigen (HLA)-matched donor
Patients who do not have human leukocyte antigen (HLA)-matched (defined as matched in HLA A, B, C, and DRB1) related or unrelated donors
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)
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
RECIPIENT: 10/10 or 9/10 human leukocyte antigen (HLA)-matched related or unrelated donor or a haploidentical related donor
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
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
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
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
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)
Available 10/10 or 9/10 human leukocyte antigen (HLA)-matched related or unrelated donor or a haploidentical related donor
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
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)
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
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
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.
Availability of a suitable human leukocyte antigen (HLA)-matched related donor
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
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
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
Consenting first degree relative matched at 6/6 human leukocyte antigen (HLA) antigens (A, B, and DR)
Lack of a suitable human leukocyte antigen (HLA)-matched related donor
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
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
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)
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)
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
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
Patients must NOT have a human leukocyte antigen (HLA)-matched sibling
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
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
A fully human leukocyte antigen (HLA) matched or single antigen/allele mismatched sibling or unrelated donor is available
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
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
Patients must have two cord blood 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 10 million total nucleated cells/Kg recipient body weight (pre-thaw)
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
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
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
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
Patients must have two cord blood (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)
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
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
Must have consenting sibling matched at 6/6 human leukocyte antigen (HLA) antigens (A, B, DR)
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)
DONOR: Human leukocyte antigen (HLA) >= 7/8 related or unrelated donors
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
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)
Patients transplanted from related or unrelated, human leukocyte antigen (HLA)-matched or mismatched donors
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
Human leukocyte antigen (HLA) identical sibling donor, HLA matched unrelated donor, or donor mismatched at 1 HLA allele or antigen
No available human leukocyte antigen (HLA)-matched related donor
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 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
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
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
The patient has a human leukocyte antigen (HLA)-matched donor and is eligible for allogeneic transplantation for CML treatment.
DONOR: age >= 12 and =< 75 years
DONOR: Donor is at least 18 years of age
Donor age >= 18 years
DONOR: At least 18 years of age
DONOR: 12 to 70 years of age - priority should be given to age (< 35 years), followed by HLA matching (haploidentical and if not available then fully mismatched donor)
DONOR: Voluntary written consent (using assent form if donor < 18 years of age)
DONOR: Age > 14 years
DONOR: At least 18 years of age
< 70 years of age with no matched 5/6 or 6/6 sibling donor - patients >= 70 and =< 75 years of age may be eligible if they have a co-morbidity score =< 2
DONOR: Age >= 18 and =< 70 years
DONOR: Age 18 to 70 years of age
DONOR: Age =< 60 years of age
DONOR: Age >= 18 years
MATCHED RELATED DONOR: Age 6-70 years
HAPLOIDENTICAL RELATED DONOR: Age 6-70 years
MATCHED RELATED DONOR: Age less than 6 years or greater than 70 years
HAPLOIDENTICAL RELATED DONOR: Age less than 6 years or greater than 70
DONOR: At least 18 years of age
DONOR: Age >= 0.5 years
DONOR: Donor must be 16 years of age or older and weigh at least 110 pounds
DONOR: There is no upper age limit for donors; however, the minimum age for a related donor is 7 years as this is the youngest age a person can be considered capable of giving assent to participate in a research study
HAPLOIDENTICAL RELATED DONOR: Age 4-60 years and weight of >= 15 kilograms
DONOR: Age >= 12 years
DONOR: Age >= 12 years of age
DONOR: Age >= 17
DONOR: Age less than 18 years
DONOR: 14-75 years of age
DONOR: Age >= 0.5 years
DONOR: Age >= 18 years and =< 60 years
DONOR: 18 to 75 years of age
DONOR: At least 18 years of age
DONOR: 14-75 years of age
DONOR: Children less than 12 years of age.
DONOR: Age < 12 years
DONOR: Age less than 12 years
DONOR: Age < 60 years
DONOR: Age > 18 years (yr)
MSC DONOR: age >= 18 years, =< 30 years
INCLUSION CRITERIA - HPC-A CELL DONOR: At least 18 years of age
DONOR: At least 18 years of age
DONOR: At least 18 years of age
DONOR: At least 18 years of age
DONOR: Age 18 years to 80 years
DONOR: Age >= 18 years
DONOR: Age < 18 years
Must be >= 18, but < 70 years of age with no matched 5/6 or 6/6 sibling donor - patients >= 70 and =< 75 years of age may be eligible if they have a Co-Morbidity score =< 2
DONOR: Age >= 18 years
DONOR: Age < 18 years
Must be >= 18, but < 70 years of age with no matched 7/8 or 8/8 sibling donor - patients >= 70 and =< 75 years of age may be eligible if they have a co-morbidity score =< 2
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.
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.
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
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
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).
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
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)
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.
Unrelated donor must be an 8/8 match at HLA-A, -B, -C and -DRB1 at high resolution using DNA-based typing. Unrelated donor must be medically eligible to donate according to National Marrow Donor Program (NMDP) (or equivalent donor search organization) criteria. At time of enrollment, the donor should not have any known preferences or contraindications to donate bone marrow or peripheral blood stem cells. (Selection of unrelated donors is to be performed according to institutional practice. It is recommended that the time from collection to initiation of the cell processing be considered when prioritizing donors, as data shows better results for CD34 selection when cell processing begins within 36 hours of the end of collection)
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.
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. Unrelated donor must be willing to donate peripheral blood stem cells and be medically cleared to donate stem cells according to National Marrow Donor Program (NMDP) criteria.
Intent to proceed with RIC alloHCT if a matched sibling or matched unrelated donor is identified. There is no requirement as to the timing of the transplantation.
A suitable donor must be identified; there are no restrictions on donor type and can include a matched sibling, a matched or mismatched unrelated donor, a family haplotype matched donor or a cord blood donor (single or double)
The HLA-matched donor must be medically fit to donate and willing to donate bone marrow.
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
Any identified and available 10/10 HLA-matched related donor or 10/10 HLA-matched unrelated donor.
Available mismatched related (mMRD) or mismatched unrelated (mMUD) donor, HLA matched 8/10 or 9/10
HLA-matched related or unrelated donor available
Patients with suitably matched related or unrelated donor, as defined per institutional practice.
Patients who have a matched donor and are candidates for allogeneic bone marrow transplantation
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
Patients with Hodgkin Lymphoma with either of the following: • Primary induction failure (failure to achieve initial CR) and/or primary refractory disease OR First, Second or Third relapse AND History of prior ablative auto HSCT or ineligible for an ablative auto HSCT or ?25% residual disease after at least two reinduction chemotherapy cycles AND HLA matched family donor (6/6 or 5/6) or matched unrelated adult donor (MUD) (8/8) or matched umbilical cord blood unit (?5/6) with prethaw cell dose of at least 3 x 107/kg TNC.
No identified 8/8 (based upon A, B, C, DRB1 loci) allele matched unrelated donor, or unable to wait sufficient time to procure an 8/8 allele matched unrelated donor
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)
Patients with no available and suitably matched related or unrelated donor in the required time period.
Patients without a matched related or unrelated 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 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
HLA-MATCHED UNRELATED DONOR: 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
Meets institutional criteria for a RIC allogeneic (allo) BMT to treat a B?cell derived hematologic malignancy of a fully matched or partially mismatched related or unrelated donor source
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)
Patient must not have a 10/10 HLA matched family member or unrelated donor.
Subjects have undergone alloSCT > 90 days prior to enrollment from a matched-related donor (MRD), matched-unrelated donor (MUD), cord blood donor, or haplo-identical and cord blood donor
DONOR: HLA 6/6 matched related or unrelated donor
Patients must have a haploidentical related donor or a fully matched related or unrelated donor
Subjects must have a suitable stem cell donor available who may donate cells if the subject needs to undergo allogeneic hematopoietic cell transplant (HCT); donor may be matched or mismatched and must be found to be suitable according to the institution’s standard criteria
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 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
Will be matched at least as HLA -A, -B, C and -DRB1; criterion for donation will be those allowing donation following the National Marrow Donor Program (NMDP) accepted donor criterion and program standard operating procedures (SOPs) for the typical matched unrelated donors
No HLA matched sibling or matched unrelated donor is available
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
Donor source is matched related, unrelated, haploidentical donor or cord blood.
DONOR: 10 of 10 HLA-matched or 1 allele mismatched (9 of 10) unrelated donor
Available familial haploidentical (4 to 6 out of 8 HLA loci-matched) donor
Donor is either matched related, matched unrelated, mismatched unrelated, or haploidentical; cord blood recipients are also eligible
HLA-matched donor able to donate
Patients must have an allogeneic hematopoietic progenitor cell donor (HPCT), either a matched sibling, mismatched (1 allele) sibling, or a matched unrelated donor (MUD) or a mismatched (1 allele) unrelated donor\r\n* Previous autologous hematopoietic progenitor cell transplantation is allowed; a minimum of 6 months should have elapsed from prior autologous hematopoietic progenitor cell transplantation; prior transplantation with conditioning regimens using total body irradiation is not allowed
Haploidentical Related Donor Selection Criteria: the recipient must have a related donor haploidentical for HLA A, B, C, and DR (i.e. matched at one locus); they may be partially matched on the other haplotype; if a matched sibling donor is available but disease status (poor disease control, recurrence after allogeneic HSCT) precludes treatment on other protocols, a haplo-identical relative is preferred as the HSC (cluster of differentiation [CD]34+ cell) source
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: Ability to give informed consent
MATCHED RELATED DONOR: History of other medical conditions that in the opinion of PI constitute a contraindication to donation
MATCHED UNRELATED DONOR: Failure to qualify as an NMDP donor
Patients must have a fully-matched sibling donor or a matched unrelated donor identified
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
HLA-matched related donor able to donate
Absence of a suitable related or unrelated bone marrow donor who is molecularly matched at HLA-A, B, Cw, DRB1, and DQB1
No available 10/10 or 9/10 HLA-matched related or unrelated donor or haploidentical related donor
MATCHED RELATED DONOR: Age 2-60 years, and weight of >= 10 kilograms
MATCHED RELATED DONOR: At least one normal DOCK8 allele demonstrated by a CLIA-certified lab
MATCHED RELATED DONOR: History of severe cutaneous viral infections with herpes simplex, herpes zoster, or molluscum contagiosum
MATCHED RELATED DONOR: HIV infection
MATCHED RELATED DONOR: Chronic active hepatitis B; donor may be hepatitis core antibody positive
MATCHED RELATED DONOR: Other medical conditions that in the opinion of the PI constitute exclusion as a donor
MATCHED RELATED DONOR: Mutation of DOCK8 on both alleles
MATCHED UNRELATED DONOR: Failure to qualify as an NMDP 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
Available matched related or unrelated donor; selected donor must be a complete match or have only a single antigen mismatch
No available and suitably matched related or unrelated donor
Very well-matched related or unrelated donor
DONOR: An unrelated donor–fully matched
DONOR: An unrelated donor–9/10 matched
Patients who have a matched related donor who is eligible and willing to donate stem cells
All patients, irrespective of participation in a clinical trial, must have a signed informed consent for the performance of matched related donor transplantation
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
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
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
Availability of a suitable matched related (6/6 or 5/6) or unrelated donor (10/10 or 9/10 antigen or allele matched)
Is undergoing matched or single-antigen mismatched unrelated-donor myeloablative transplant for the treatment of ALL or AML; Is less than or equal to (<=) 60 years of age For the cohort after Recommended phase 2 dose (RP2D)
Is undergoing matched or single-antigen mismatched related or unrelated-donor transplant and receiving myeloablative conditioning or RIC for the treatment of hematologic malignancies or myeloproliferative neoplasms; Is less than or equal to (<=) 75 years of age
Matched Related Donor: Related to the patient and is genotypically or phenotypically HLA-identical
Matched Related Donor: Donor age < 75 yrs unless cleared by institutional PI
Matched Related Donor: Donor must consent to PBSC mobilization with G-CSF and apheresis
HLA Matched Unrelated Donor: Donor must consent to PBSC mobilization with G-CSF and apheresis; bone marrow unrelated donors are not eligible for this protocol
Matched Related Donor: Identical twin
Matched Related Donor: Any contra-indication to the administration of subcutaneous G-CSF at a dose of 16mg/kg/d for five consecutive days
Matched Related Donor: Serious medical or psychological illness
Matched Related Donor: Pregnant or lactating females
Matched Related Donor: HIV seropositivity
Known HLA matched related donor without contraindications to donate
HLA-matched donor able to donate
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.
Subjects should have a potential 3-5/6 HLA-matched related haploidentical donor that will be evaluated for eligibility to provide DLI
DONOR: Patients must have a healthy 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: 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
Patients must have a fully-matched related donor or a matched unrelated donor identified; double cord (at least 4/6 matched) can be used if no adult matched donor is available
MATCHED RELATED DONOR: History of medical illness that in the estimation of the PI or Department of Transfusion Medicine (DTM) physician precludes donation of marrow
MATCHED RELATED DONOR: Pregnant females
MATCHED RELATED DONOR: Any medical contraindication to anesthesia or marrow donation will exclude the donor
MATCHED RELATED DONOR: Active autoimmune disease that in the opinion of the PI or AI would compromise the success of the transplant
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
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
No available suitably HLA- matched unrelated donor
Available suitably HLA- matched unrelated donor is unwilling to donate peripheral blood stem cells (PBSC), and no alternate donor is found
Availability of appropriate, willing, HLA-matched related marrow donor
Matched related or unrelated donor identified and available; donor must be a complete match or have only a single allele or antigen mismatch
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
Patient must have a fully matched related or unrelated donor willing to donate stem cells
Must have suitable matched sibling or matched unrelated donor for stem cell source
For Pre-allo Part A (before stem cell transplant): Availability of an HLA matched related or unrelated donor
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.
HLA-matched donor able to donate
Patient should have an already identified sibling, matched unrelated donor or cord blood donor at the time of enrollment to this clinical trial
No available suitable matched related (6/6 or 5/6) or unrelated donor (8/8 or 7/8 allele matched) or unwilling or unable to pursue allogeneic stem cell transplant
Does not have a suitable matched related/sibling donor (MSD) or volunteer matched unrelated donor (MUD) available in the necessary time for stem cell donation
Subjects with who have undergone a non-myeloablative allogeneic transplant, using a 3-6/6 HLA matched related donor
Patients < 55 years (myeloablative regimen #1) or > 55 and =< 75 years or significant comorbidities (reduced intensity regimen #2) old lacking a matched related volunteer donor identified in time for transplant for which a related haploidentical donor (=< 7/8 allele match at the A, B, C, DR loci), a 7/8 allele matched related or unrelated donor is identified, or a matched unrelated donor (MUD); the patients must be diagnosed with high-risk disease as following:
Matched unrelated donor must consent to provide a marrow allograft
Matched (8/8) or mismatched (7/8) related, unrelated HCT
Patient has a suitable and willing HLA-8/8 matched or 7/8 mismatched (at one allele) unrelated donor identified
Patients must have a related or unrelated donor as follows:
Availability of a suitable 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated mPB donor;
Patients who have undergone allogeneic HSCT in CR1 from a matched related or matched unrelated donor. All of the following criteria must also be met:
Histocompatible donor identified:\r\n* Related donor or unrelated donor matched 5/6 or better (A, B, DRB1)
Available matched unrelated donor
Donor choices per matched unrelated donor (MUD) committee according to center standard operating procedure (SOP)
Recipients of 8-7/8 HLA-matched donor; post-HSCT period within day +100 to day +150
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
Planned recipient of a first kidney allograft from an HLA-matched, living related donor
Patient plans on receiving stem cells from a matched (8/8) related donor
Clinical justification of allogeneic stem cell transplantation where a suitable HLA matched sibling or unrelated donor is unavailable in a timely manner. An unrelated donor search is not required for a patient to be eligible if the clinical situation dictates an urgent transplantation. Clinical urgency is defined as 6-8 weeks from referral to transplant center or low likelihood of finding a matched unrelated donor
Availability of a fully matched related or unrelated donor following a donor search
HLA-matched, related or 7-or 8/8 allele matched (HLA-A,-B,-Cw,-DRBl) unrelated donor able to donate.
DONOR: HLA-identical sibling
Patients with age =< 10 years undergoing HSCT with a matched sibling donor; these patients are at very low risk of acute GVHD and do not receive gut decontamination per our institutional standard practice
DONOR: HLA genotypically identical sibling matched relative
Available HLA identical matched sibling donor (unless having failed a prior allogeneic transplant from an HLA identical matched sibling)
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
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
Availability of an 8 of 8 (HLA-A, B, C and DRB1) HLA matched sibling or matched unrelated donor
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
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
Persons with a HLA matched sibling donor
DONOR: Related donor (parents, sibling, offspring, or offspring of sibling)
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
DONOR: HLA-matched or single allele mismatched sibling of enrolled transplant patient
Patients must be medically ineligible for allogeneic stem cell transplant (alloSCTx) or not have a known fully HLA matched sibling for planned sibling transplant
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 with an available 5-6/6 HLA-A, B, DRB1 matched sibling donor
HLA-identical sibling
Patients who are ineligible for or refuse BMT from a HLA-matched, sibling donor
< 70 years with an available 5-6/6 HLA-A, B, DRB1 matched sibling donor
DONOR: A sibling donor–fully matched
DONOR: A sibling donor–haploidentical
Patients must have a 10/10 matched sibling peripheral blood progenitor cell donor
Availability of a genetic child, genetic parent or sibling as a potential HLA haploidentical donor
No 10/10 matched sibling donor available or not financially eligible for allogeneic stem cell transplantation
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
DONOR: Related donor (sibling, parent, offspring, parent or offspring of an HLA identical sibling) >= age 14 years (if < 18 years, > 40 kg)
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
DONOR: Related donors (sibling, parent, offspring, parent or offspring of an HLA identical sibling)
Matched sibling or un-related donor (A, B, C, and DR) available to undergo leukopheresis
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
Suitable, 6/6 HLA matched related sibling donor available
DONOR: Human leukocyte antigen (HLA) identical sibling donor
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
DONOR: Related donors (sibling, parent, offspring, parent or offspring of an HLA identical sibling)
DONOR: Related donor (sibling, parent, offspring, parent or offspring of an HLA identical sibling) 12-75 years of age (it is recognized individual institutions may have differing donor age guidelines; this is acceptable as long as no donor is younger than 12 years or older than 75 years)
DONOR: HLA-matched or -haploidentical, parent, child, sibling, or half-sibling of the recipient
Must have a potential haploidentical donor (parent, sibling, child)
DONOR: Related donors (sibling, parent, offspring, parent or offspring of an HLA identical sibling) age 12 to 75 years
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.
DONOR: Sibling who is 6/6 HLA-matched with recipient
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
DONOR: HLA genotypically identical sibling
DONOR: HLA genotypically identical sibling
Availability of a suitable HLA-matched sibling or unrelated donor in a donor search
Presence of a readily available 6/6 matched sibling donor who is a candidate for donation
Sibling Donor Transplant
DONOR: Donors who are HIV-positive and/or, medical conditions that would result in increased risk for G-CSF mobilization and harvest of PBSC
Patients and donors must be able to sign consent forms (or if a minor the parent will sign); donors should be willing to donate
DONOR: Donors must meet the selection criteria as defined by the Foundation for the Accreditation of Hematopoietic Cell Therapy (FAHCT) and will be screened per the American Association of Blood Banks (AABB) (AABB guidelines and the recipients will be informed of any deviations)
DONOR: Donor parity and sex mismatch, have also been associated with an increased risk of acute GVHD (aGVHD) and decreased survival in some but not all studies; donor age and weight should be also taken into consideration\r\n* Suggestions (in no order of priority):\r\n** Younger (18 years of age or older) and lighter donors should be preferred\r\n* If all else is equal, male donors may be preferred over nulliparous female donors who may be preferred over multiparous female donors\r\n* Other factors such as donor age and health history will be integrated into the donor selection process per standard practice and may be prioritized over HLA, ABO and CMV status; children donors may be used if appropriate
DONOR: Donors who do not fulfill criteria as apheresis donors as established by institutional guidelines
DONOR: HIV-positive donors
DONOR: Unrelated donors must be >= 18 as per National Marrow Donor Program (NMDP) guidelines
DONOR: Related donors will be selected from the patient’s family members and relatives; preference will be given to related donors over the age of 18 whenever possible; if minor donors are to be enrolled, they will be a minimum of 12 years old
DONOR: Related donors must meet all requirements to donate as per Lucile Packard Children's Hospital (LPCH) standard of procedure (SOP) for donors
DONOR: Related donors for recipients who have monogenetic mutations must be unaffected; for recipients with de novo mutations, testing of related donors is largely not required, but is recommended in all cases and is required when the donor is the child of the recipient; mutation testing needs to be performed by a CLIA-certified lab, if such testing is available; for donors who carry one mutated allele of a PID which is inherited in either an autosomal recessive or X-linked fashion, the donor must have no discernable symptomatology or penetrance of the mutation suggesting that they are affected carriers; this should be verified through disease-appropriate quantitative and functional assays to assess the function of the potential donor’s immune system (e.g. whole blood EBV DNA quantitative polymerase chain reaction [qPCR], natural-killer group 2, member D [NKG2D] activity, T, B, and natural killer cells [TBNK] panel, and quantitative immunoglobulin levels for a female carrier of the magnesium transporter 1 [MAGT1] mutation that causes X-linked immunodeficiency with magnesium defect, Epstein-Barr virus infection, and neoplasia [XMEN]); furthermore, the X-chromosome inactivation pattern should be assessed for female carriers of X-linked diseases if they are considered as potential donors to confirm favorable and complete lyonization of hematopoietic cells; for PIDs inherited in an autosomal dominant fashion, donors who have one mutated allele for the recipient’s disease will be considered ineligible to donate, regardless of the donor’s phenotype; additional blood tests may be required to assess for quantitative and/or qualitative defects in the donor’s immune system, particularly in cases where PID mutation testing is not available or the PID mutation is not identified\r\n* A NIAID protocol (07-I-0033, Detection and Characterization of Infections and Infection Susceptibility, PI: Steve Holland) is already in place and will handle all the genetic/genomic analysis for recipients and potential donors on this protocol, including the management of results, genetic counseling, and education
DONOR: Related donors undergoing bone marrow harvest should be deemed fit for the operative procedure and related donors undergoing apheresis should be deemed fit for the collection procedure
DONOR: Related donors will undergo the donor health history screen by skilled staff in the Blood Services Section for adult donors and age-appropriate questioning when indicated for pediatric donors to determine donor eligibility using standard Department of Transfusion Medicine (DTM) criteria
DONOR: Unrelated donors will be evaluated in accordance with existing National Marrow Donor Program (NMDP) Standard Policies and Procedures except for the additional requirement of EBV serostatus testing; note that participation in this study is offered to all unrelated donors but not required for clinical donation, so it is possible that not all unrelated donors will enroll on this study
DONOR: Donors unwilling to donate PBSC
Unrelated donors donating outside of the United States of America (USA)
HEALTHY VOLUNTEER BLOOD DONORS
DONOR: PBSC is the preferred cell source (when feasible) for fully matched donors; PBSC may also be used for a mismatched donor following discussion with the PI; bone marrow is allowed when PBSC is not feasible or as determined by the PI
DONOR: Both arms: All donors in both arms should be evaluated and approved by DSC
DONOR: Donors who are HIV-positive and/or, medical conditions that would result in increased risk for G-CSF mobilization and harvest of peripheral blood stem cell (PBSC)
DONOR: Ability of donors < 18 years of age to undergo bone marrow harvest
DONOR: Donors must meet the selection criteria prior to the start of the recipient’s pre-transplant conditioning regimen as defined by the Foundation for the Accreditation of Cell Therapy (FACT) and will be screened according to the American Association of Blood Banks (AABB) guidelines and University of Wisconsin Bone Marrow Transplant (UW BMT) program Standard Operating Procedure (SOP)
Potential donors under the age of 18 must have a single patient exemption approved by the Institutional Review Board (IRB); the donor must provide assent and the donor’s parent or guardian must provide permission for minor participation; donors under the age of 18 who cannot assent based on their developmental stage will not be included
DONOR: For younger donors, no more than 20 mL bone marrow may be harvested per kg of donor body weight
RESEARCH PHASE INCLUSION CRITERIA:\r\nDONOR: Verification of donor eligibility (clearance must be received from the NMDP)\r\n* Donors are evaluated by NMDP affiliated donor centers per NMDP Standards\r\n** Donors who are medically suitable, but ineligible by Food and Drug Administration (FDA) guidelines may still donate peripheral blood stem cells (PBSC) with documentation of urgent medical need by the PI\r\n** Patients who receive stem cell products from ineligible donors will be informed of any increase in risk of transfusion-related diseases prior to initiation of conditioning chemotherapy\r\n* Donors who are ineligible or unwilling to donate bone marrow will not be eligible to donate to study recipients; however, in the event that the patient has already begun conditioning chemotherapy and a donor PBSC collection is terminated early for donor-related medical concerns, a bone marrow graft may be infused; should this occur, the recipient will be removed from the study, but will continue to be managed on this protocol for all transplant-related care and complications\r\n* Inadequate stem cell collection from the selected donor is defined as less than or equal to 2 x 10^6 cluster of differentiation (CD)34+ cells/kg; in most cases, donor cell collections are infused fresh; if a fresh collection is found to have an inadequate cell count, the cells will still be infused, but the recipient will be removed from the study, and managed clinically for all transplant-related care and complications on this protocol; if the patient fails to engraft, the donor may be requested for a second collection or an emergency bone marrow harvest at the discretion of the PI and NMDP Medical Director; in the event of an inadequate collection obtained prior to patient conditioning, the donor may be asked to donate a second time, or another eligible donor may be requested
DONOR: Male donors will be preferred to avoid reactivity against H-Y minor histocompatibility antigens and associated risk of risk of acute GvHD, especially grafts from multiparous women
DONOR: Younger donors will be preferred
DONOR: Haploidentical-(related) donor’s age should be 4-60 years and weigh > than 20 kg; general preference of related haplo-identical marrow HSC donors prioritizes male relatives over female relatives and younger age balanced with size and ease/safety of marrow collection
MATCHED UNRELATED DONOR: The evaluation of donors shall be in accordance with existing National Marrow Donor Program (NMDP) Standard Policies and Procedures
DONOR: Donors must meet the selection criteria as defined by the Foundation for the Accreditation of Hematopoietic Cell Therapy (FACT)
DONOR: Donors will be selected from among the subject’s relatives, adult children preferred
Must have donor peripheral blood stem cells mobilized by National Marrow Donor Program (NMDP) standards; no bone marrow donors
DONOR: If donors do not meet institutional guidelines, exclusion will be considered
Severe alloimmunization with inability to guarantee a supply of adequate PRBC donors
DONORS: Donors in groups 1 and 2 would have already been determined to be eligible and will have donated blood or leukocytes to establish EBV-specific T-cells under IRB # 05-065, 07-055, 95-024, or 12-086; there are no additional eligibility requirements for these donors
DONORS: Donors in group 3, however, will need to meet the following eligibility requirements prior to donation:\r\n* Donors must satisfy the criteria specified in Food and Drug Administration (FDA) 21 Code of Federal Regulations (CFR) 1271\r\n* Donors must be typed for HLA-A, B, C, and DR\r\n* Donors must have a hemoglobin value > 10 g/dl\r\n* Donors must be capable of undergoing, at least, a single standard 2 blood volume leukapheresis or a donation of one unit of whole blood
DONOR: Serologic testing for transmissible disease will be performed as per institutional guidelines adopted from extant National Marrow Donor Program (NMDP) and Foundation for Advancement in Cancer Therapy (FACT) guidelines; donors should be considered eligible to donate leukapheresis or blood based on these guidelines (i.e. blood donation guidelines)
DONOR: Potential donors consist of:\r\n* Unrelated donors\r\n* Second-degree relatives\r\n* First cousins
MATCHED RELATED DONORS: Matched related donors that will have their cells collected via apheresis will also undergo the donor health history screen to determine donor eligibility using standard DTM criteria in the Dowling Apheresis Clinic by skilled staff in the Blood Services Section for adult patients and age-appropriate questioning when indicated for pediatric subjects
HAPLOIDENTICAL RELATED DONOR: Adult related donors would be preferred over related donors who are minors
DONOR: Donors will be excluded if for medical or psychological reasons they are unable to tolerate the procedure of peripheral stem cell donation
DONOR: If donors do not meet institutional guidelines, exclusion will be considered
DONOR: History of hypertension that is not controlled by medication, stroke, or severe heart disease (donors with symptomatic angina will be excluded); donors with a history of coronary artery bypass grafting or angioplasty who are symptom free will receive a cardiology evaluation and be considered on a case-by-case basis
DONOR: Donors must not be pregnant
DONOR: Anemia (Hb < 11 gm/dl) or thrombocytopenia (platelets < 100,000 per ul); however, potential donors with Hb levels < 11 gm/dl that is due to iron deficiency will be eligible as long as the donor is initiated on iron replacement therapy; the NIH Clinical Center, Department of Transfusion Medicine/NMDP physicians will determine the appropriateness of individuals as donors
DONOR: Ability of donors < 18 years of age to undergo apheresis without use of a vascular access device; vein check must be performed and verified by an apheresis nurse prior to arrival at the Seattle Cancer Care Alliance (SCCA)
DONOR: Donors must meet the selection criteria as defined by the Foundation for the Accreditation of Cell Therapy (FACT) and will be screened per the American Association of Blood Banks (AABB) guidelines
DONOR: In the case that PBMC will be used as stem cell source, ability of donors < 18 years of age to undergo apheresis without use of a vascular access device; vein check must be performed and verified by an apheresis nurse prior to arrival at the Seattle Cancer Care Alliance (SCCA)
DONOR: all donors will have to meet the standard infectious diseases criteria (Children’s Memorial Hospital Stem Cell Transplant Program policy VII-B entitled Allogeneic Donor Identification, Evaluation, Education, Consent and Management) and study-specific infectious disease criteria prior to study entry
DONOR: Donors will be < 55 years of age and in good health as approved by the National Marrow Donor Program (NMDP) donor and collection centers; related donors will be < 70 years of age
Patients and donors must be able to sign consent forms; partially mismatched (at least haploidentical) first degree relative should be willing to donate
DONOR: Donors must meet the selection criteria as defined by the Foundation for the Accreditation of Hematopoietic Cell Therapy (FAHCT) and will be screened per the American Association of Blood Banks (AABB); (AABB guidelines and the recipients will be informed of any deviations)
Related donors will be assessed and collected through University of Minnesota BMT protocol MT2012-14C: “Procedure Guidelines For Related Hematopoietic Stem Cell Donors.”
Donor screening; all donors will meet the standard blood donor criteria established by the participating local blood center, American Association of Blood Banks (AABB)
Donors will be selected from among the subject’s relatives, adult children preferred
Donors regardless of match and selection criteria must:\r\n* Not be affected by the same disease making the patient eligible for alloHCT; disease carriers may be permitted depending on the clinical situation\r\n* Meet donor criteria as outlined in University of Minnesota protocol MT2012-14C: Procedure Guidelines for Related Hematopoietic Stem Cell Donors
DONOR: Donors weighing less than 40 kg (children) will need evaluation by a pediatrician for suitability of the apheresis procedure
DONOR: Donors able to undergo peripheral blood stem cell collection or bone marrow harvest
DONOR: Weight >= 15 kilograms and for unrelated donors, >= 18 years
DONOR: For donors >= 18 years of age, ability to give informed consent
Donors: Identical twin
Donors: Pregnancy
DONOR:\r\n* First-degree relative with genotypic identity at 6/6 HLA loci (HLA- A, B, and DR)\r\n* Age 11 to 90 years and able to give consent or assent; for donors < 18 years old, the legal guardian must be able to provide informed consent\r\n* Adequate venous access for peripheral apheresis, or consent to use a temporary central venous catheter for apheresis\r\n* Donors must be human immunodeficiency virus (HIV) negative\r\n* Donors with a history of hepatitis B or hepatitis C infection may be eligible; however, eligibility determination of such patients will require a hepatology consultation; the risk/benefit of the transplant and the possibility of transmitting hepatitis will be discussed with the patient and eligibility will then be determined by the principal investigator and LAI\r\n* Lactating donors must substitute formula feeding for her infant during period of filgrastim administration (to prevent any filgrastim effect on infant)
DONOR:\r\n* History of psychiatric disorder which may compromise compliance with transplant protocol, or which does not allow for appropriate informed consent\r\n* History of hypertension that is not controlled by medication, stroke, autoimmune disease, or severe heart disease (donors with symptomatic angina will be excluded); donors with a history of coronary artery bypass grafting or angioplasty who are symptom free will receive a cardiology evaluation and be considered on a case-by-case basis\r\n* History of prior malignancy; however, cancer survivors who have undergone potentially curative therapy may be considered for stem cell donation on a case-by-case basis; in addition, donors with localized cancer such as prostate cancer that are on a watch-and-wait management due to the low-risk of disease progression may also be considered for stem cell donation on a case-by-case basis; the risk/benefit of the transplant and the possibility of transmitting viable tumor cells at the time of transplantation will be discussed with the patient\r\n* Donors must not be pregnant (unknown effect of filgrastim on fetus); donors of childbearing potential must use an effective method of contraception\r\n* Anemia (hemoglobin [Hb] < 11 gm/dl) or thrombocytopenia (platelets < 100,000 per ul); however, potential donors with Hb levels < 11 gm/dl that is due to iron deficiency will be eligible as long as the donor is initiated on iron replacement therapy and the case is individually approved by NIH or Hackensack Blood Bank
DONOR: Donors must meet the selection criteria as defined by the Foundation for the Accreditation of Hematopoietic Cell Therapy (FACT)
DONOR: If there is more than one donor option based on the above criteria, additional suggested criteria to consider (in no order of priority as none of these characteristics have been shown to make a difference in the setting of haploBMT with post-transplantation cyclophosphamide [PT/Cy]) include:\r\n* Younger adults age >= 18 years and non-obese donors should be preferred\r\n* If all else is equal, male donors may be preferred over nulliparous female donors who may be preferred over multiparous female donors\r\n* If all other criteria equal and if the patient and family express a strong preference for a particular donor, that donor should be selected
Cadaveric and donation by cardiac death (DCD) donors (no living donor liver transplantation [LDLT])
Unrelated Donor: Marrow donors
Unrelated Donor: Donors who are HIV-positive and/or medical conditions that would result in increased risk to the donor G-CSF mobilization and G-PBMC collections
DONOR: Marrow donors
DONOR: Donors who are HIV-positive and/or medical conditions that would result in increased risk to the donor filgrastim (G-CSF) mobilization and PBSC collections
DONOR: Considered medically eligible for leukopheresis procedure by independent donor physician (University of Pennsylvania physician who is not the recipient’s primary transplant physician for related donors; physician designated by National Marrow Donor Program for unrelated donors)
DONOR: Unrelated donors donating outside of the United States of America (USA) or Germany
DONOR: Donors must meet the selection criteria prior to the start of the recipient’s pre-transplant conditioning regimen as defined by the Foundation for the Accreditation of Cell Therapy (FACT) and will be screened according to the American Association of Blood Banks (AABB) guidelines and UW Bone Marrow Transplant (BMT) program standard operating procedure (SOP)
DONOR: Donors must be capable of undergoing leukapheresis
DONOR: Female donors must not be pregnant or lactating
DONOR: Donors must not have developed a new malignancy requiring chemotherapy or radiation in the interval since apheresis for transplant
RELATED DONORS:
DONOR: Donor must consent to PBSC mobilization with G-CSF and apheresis as well as collection and donation of plasma; bone marrow unrelated donors are not eligible for this protocol
MATCHED RELATED DONOR: Donors must be physically able to and willing to tolerate marrow harvest collection preferably, or in the absence of this option, able and willing to donate via peripheral blood pheresis
MATCHED UNRELATED DONOR: The evaluation of donors shall be in accordance with existing National Marrow Donor Program (NMDP) Standard Policies and Procedures at all institutions
DONOR: Donors who are HIV-positive and/or, medical conditions that would result in increased risk for G-CSF mobilization and harvest of PBSC
DONOR: Adult donors must be capable of providing informed consent; potential donors under the age of 18 must have a ‘single patient exemption’ approved by the Institutional Review Board (IRB) and the donor and a guardian must provide assent
DONOR: Donors with a known allergy to E. coli-derived products are ineligible for mobilization with G-CSF; alternatives may be used and would have to be discussed individually in these rare circumstances
DONOR: Haploidentical donor selection will be based on standard institutional criteria, otherwise no specific prioritization will be made amongst the suitable available donors; donors will not be selected based on killer cell immunoglobulin-like receptor (KIR) status
DONOR: Donors unable or unwilling to undergo marrow harvest for the initial HCT, storage of autologous blood prior to marrow harvest or apheresis one week after marrow harvest
DONOR: HIV-positive donors
DONOR: The evaluation of donors shall be in accordance with existing NMDP Standard Policies and Procedures
DONOR: Donors who are not suitable for medical reasons to donate peripheral blood mononuclear cells (PBMC) by continuous centrifugation according to the criteria of the American Association of Blood Banks (AABB)
DONOR: Age < 75 years (yrs), older donors may be considered after review at Patient Care Conference
DONOR: Donors must meet the selection criteria as defined by the Foundation for the Accreditation of Cell Therapy (FACT) and will be screened per the American Association of Blood Banks (AABB) guidelines
DONOR: all donors are selected and screened for their ability to provide adequate infection-free apheresis products for the patient
DONOR: donors should be selected based on two principles\r\n* First, a parent or offspring is preferable to siblings\r\n* Second principle is that the donor will optimally have natural killer (NK) cells that express killer immunoglobulin (Ig)-like receptors that are mismatched with the subject’s HLA receptor ligands
DONOR: Donors must meet the selection criteria as defined by the BMT Policy Manual
DONOR: Adult donors must be the same donor used for the non-myeloablative allogeneic transplant and a related family member with a HLA 3-6/6 match with the subject and must be capable of providing informed consent; potential donors under the age of 18 must have a ‘single patient exemption’ approved by the Institutional Review Board (IRB) and the donor and a guardian must provide assent; the donor must be the same donor used for the original allogeneic transplantation; selection of donors will be compliant with 21 Code of Federal Regulations (CFR) 1271
DONOR: Donors will complete the Adult Donor History Questionnaire and have all laboratory studies included in the Donor Referral National Testing Laboratory (NTL) Panel, complete blood count (CBC) with auto or manual differential, and a chemistry panel within 7 days of scheduled collection procedure; donors who were evaluated greater than 1 year prior for transplant collection will also have a history and physical exam, chest x-ray (CXR), and electrocardiogram (EKG) completed; donors must not have any medical condition which would make apheresis more than a minimal risk, and should have normal range laboratory findings; all abnormal laboratory findings will be evaluated by the treating physician within the context of the entire donor assessment process
DONOR: Allogeneic donors must not have HIV infection
DONOR: Donors must not be pregnant; donors of childbearing potential must use an effective method of contraception from the time of study entry until at least one year post-transplant
DONORS IN GROUP 1 (HISTORICAL DONORS): Donors in Group 1 would have already been determined to be eligible and will have donated blood or leukocytes to establish CMV-specific T-cells under Institutional Review Board (IRB) # 05-065, 07-055, 95-024, or 11-130; there are no additional eligibility requirements for these donors
DONORS IN GROUP 2 & 3 (PROSPECTIVE AND VOLUNTEER DONORS): Transplant donors and healthy human leukocyte antigen (HLA) typed volunteers who agree to provide T-cells for third-party donation (groups 2 and 3) will need to meet the following eligibility requirements prior to donation:\r\n* Donors must satisfy the criteria specified in Food and Drug Administration (FDA) 21 Code of Federal Regulations (CFR) 1271\r\n* Donors must be typed for HLA-A, B, C and DR\r\n* Donors must have a hemoglobin value > 10 g/dl\r\n* Donors must be capable of undergoing, at least, a single standard 2 blood volume leukapheresis or a donation of one unit of whole blood
DONOR: Donors with impaired cardiac function are excluded. Electrocardiography is routine for potential HCT donors over 60 years old and those with a history of heart disease. Subjects in whom cardiac function is abnormal (excluding 1st degree branch block, sinus brachycardia, sinus tachycardia or non?specific T wave changes) are ineligible for Triplex vaccination
DONOR: related donors must meet eligibility criteria as per BMT Standard Operating Procedures (SOP) 1002
PBSC donors must meet the same criteria as NMDP marrow donors. These criteria are set forth in NMDP Standards and the Donor Center Manual of Operations.