Any documented donor-derived PTLD
7. Patients are eligible if no formal unrelated donor search has been activated prior to date of consent. A formal unrelated donor search begins at the time at which samples are requested from potential National Marrow Donor Program (NMDP) donors. Patients who have started a sibling donor search or who have found a matched sibling donor are eligible.
DONOR: Donor (or centers) who will exclusively donate marrow
Prior transfusions from selected donor
DONOR SELECTION CRITERIA, IN DECREASING ORDER OF PRIORITY:
DONOR: Donor must be medically, socially, and psychologically fit to donate
Recipients of donor/recipient ABO incompatible grafts.
DONOR: Inadequate documentation that donor and recipient are syngeneic
DONOR: Concordant for autoimmune neurological disease(s) as determined by neurological evaluation
DONOR: Donor-recipient pairs in which the HLA-mismatch is only in the host-versus-graft (HVG) direction; patients are homozygous and donor is heterozygous
DONOR: Pregnant females will not be eligible to donate as per NMDP and LPCH guidelines
Planned preemptive/prophylactic administration of donor lymphocytes (as per section 2.5.2)
Available alternative donor:
DONOR: Other medical constraints that in the opinion of the PI constitute exclusion
DONOR: Unrelated donors: failure to qualify as a National Marrow Donor Program (NMDP) donor per current NMDP standards
DONOR: Identical twin
DONOR: Pregnancy
DONOR: Current serious systemic illness
DONOR: Patient and donor pairs must not be homozygous at mismatched allele
Available donor-derived multiTAA-specific T cell line
DONOR ELIGIBILITY
Available donor-derived multiTAA-specific T cell line
DONOR ELIGIBILITY
Known T-cell donor chimerism of < 50%
DONOR INCLUSION:
DONOR EXCLUSION:
Patients who don't have an eligible donor are ineligible.
DONOR: blood relative of the subject
DONOR: meet criteria for related donor including infectious disease testing and history and physical exam and receive clearance by transplant physician per University of Utah standard operating procedure (SOP)
DONOR: Donor is a family member
DONOR: Donor is not pregnant or breast-feeding
DONOR: Donor is human immunodeficiency virus (HIV) negative
DONOR: Donor does not have any other medical condition that, in the opinion of an independent physician, precludes performance of an apheresis procedure
DONOR: With active infectious hepatitis
DONOR: Meet standard criteria for donor collection as defined by the National Marrow Donor Program Guidelines.
DONOR: Donor selection for both arms must be approved by the donor selection committee
DONOR: Medical or physical reason which makes the donor unlikely to tolerate or cooperate with growth factor therapy or leukapheresis
DONOR: Factors which place the donor at increased risk for complications from leukapheresis or granulocyte-colony stimulating factor (G-CSF) therapy could be harvested for bone marrow (BM) if safer for the donor and if approved by PI
The patient must have an identified RELATED haploidentical (haplo)-identical donor.
DONOR: The donor must be healthy and must be willing to serve as a donor, based on standard National Marrow Donor Program (NMDP) guidelines and DHMC SOP – Donor Evaluation.
DONOR: The donor must have no significant co-morbidities that would put the donor at marked increased risk.
DONOR: There is no age restriction for the donor.
DONOR: Informed consent must be signed by donor.
DONOR: Pregnant or lactating donor.
DONOR: HIV or active hepatitis (Hep) B or C in the donor.
DONOR: A donor with a psychiatric disorder or mental deficiency that makes compliance with the procedure unlikely and informed consent impossible.
DONOR: donor evaluation and eligibility will be assessed as per current City of Hope standard operating procedure (SOP)
DONOR SELECTION INCLUSION
DONOR SELECTION EXCLUSION
Physician decision (e.g., lack of available stem cell donor).
DONOR: Donor (or centers) who will exclusively donate marrow
Availability of eligible haploidentical donor
DONOR: The potential donor must be in good general health as determined by the evaluating medical provider using the UW Hematopoietic Stem Cell Transplant Program guidelines set forth in the most current standard operating policies and procedures (UW FACT-accredited CHCPL SOP) for hematopoietic cell donor evaluation and selection
DONOR: Medical or physical reason which makes the donor unlikely to tolerate or cooperate with growth factor therapy and leukapheresis
DONOR: Factors which place the donor at increased risk for complications from leukapheresis or G-CSF therapy
DONOR ELIGIBILITY
Available original donor (same donor as used for the initial stem cell transplant) that is willing and eligible for non-mobilized collection
DONOR: Same donor as used for the autologous hematopoietic cell transplantation (allo-HCT)
DONOR SELECTION:
Donor T cell engraftment after allo-HSCT (> 90% donor chimerism of the T cell compartment)
Must have baseline donor T cell chimerism of >= 20%
DONOR: Presence of a hemoglobinopathy
Available haploidentical donor willing and eligible to undergo a peripheral blood collection
All ABO blood group combinations of the donor/recipient are acceptable
Donor availability-the patient must have an identified donor\r\n* Sibling: Availability of a 6/6 identical donor\r\n* Unrelated donor: Availability of a 6/6 unrelated donor
DONOR: The donor must be healthy and must be willing to serve as a donor, based on standard NMDP guidelines and DHMC SOP – Donor Evaluation
DONOR: The donor must have no significant co-morbidities that would put the donor at marked increased risk
DONOR: There is no age restriction for the donor
DONOR: Informed consent must be signed by donor (if sibling donor) or by third party (i.e. NMDP) if unrelated donor
DONOR: Syngeneic donor
DONOR: Pregnant or lactating donor
DONOR: HIV or active hepatitis (Hep) B or C in the donor
DONOR: A donor with a psychiatric disorder or mental deficiency that makes compliance with the procedure unlikely and informed consent impossible
DONOR: Meets criteria outlined in the Foundation for the Accreditation of Cellular Therapy (FACT)-approved standard operating procedure (SOP) for \DONOR EVALUATION AND SELECTION FOR ALLOGENEIC TRANSPLANTATION\ in the Blood and Marrow Transplant Program Manual, document E-1
DONOR: Donor must be willing to undergo general anesthesia and bone marrow stem cell harvest
Donor specific antibodies against donor HLA–DQ or –DP
DONOR: Not suitable for donation according to UW BMT program donor selection SOP
Eligible NK donor
DONOR: Donor must be able to undergo leukapheresis for total volume of 10-15 liters
DONOR: There is no age restriction for the donor
DONOR: Donor is pregnant
Availability of an eligible haploidentical donor
DONOR: Donor eligibility will be determined in compliance with Code of Federal Regulations 21 CFR 1271, subpart C; for a donor to be eligible, the donor must meet donor criteria for human cells, tissues and cellular and tissue-based products; specifically, a donor is eligible under these provisions only if:\r\n* Donor screening in accordance with 1271.75 indicates that the donor:\r\n** Is free from risk factors for, and clinical evidence of, infection due to relevant communicable disease agents and diseases; and\r\n** Is free from communicable disease risks associated with xenotransplantation; and\r\n* The results of donor testing for relevant communicable disease agents in accordance with 1271.80 and 1271.85 are negative or nonreactive, except as provided in 1271.80(d)\r\n* If a donor does not meet these criteria, he/she is not eligible
DONOR: Haploidentical family members, between the ages of 18 and 65 years, identified as an eligible donor by HLA-typing; a biological parent will generally be used as the donor
DONOR: The potential donor must be in good general health as determined by the evaluating medical provider using the University of Wisconsin (UW) Hematopoietic Stem Cell Transplant Program guidelines set forth in the most current standard operating policies and procedures for hematopoietic donor evaluation and selection
Donor cellular engraftment of at least 2.5% from the reduced intensity/non-ablative procedure
DONOR: Selection of a haploidentical donor will require absence of pre-existing donor-directed anti-HLA antibodies in the recipient
DONOR: Medical or physical reason which makes the donor unlikely to tolerate or cooperate with growth factor therapy and leukapheresis
DONOR: In a state of general good health and have completed a donor evaluation with history, medical examination and standard blood tests within 60 days of starting the hematopoietic cell collection procedure; in order to fairly represent the interests of the donor, the donor evaluation and consent will be performed by a study team member other than the recipient’s attending physician
Evidence of donor engraftment as defined by institutional standard T cell chimerism > 50%.
DONOR: Avoid donor specific antibodies (DSA); select donors with a negative anti-donor cross-match
ELIGIBLE DONOR – Meets all donor screening and testing requirements related to transmission of infectious disease
ALLOGENEIC DONOR CRITERIA FOR APHERESIS DONATION: \r\n* Related donor selection will be conducted in accordance with City of Hope's Department of Hematology & Hematopoietic Cell Transplantation criteria and, in the case of unrelated donor from a transplant center, will comply with the National Marrow Donor Program's (NMDP) donor selection standards; when a potentially eligible recipient of an unrelated donor product from an NMDP Center is identified, the recipient will complete an NMDP search transfer request to allow City of Hope (COH) NMDP staff to contact the NMDP Coordinating Center, who in turn, will contact the donor's prior Donor Center; the search will follow the NMDP Policy for subsequent donation requests; any form deemed appropriate and necessary by the NMDP, including the Subsequent Donation Request Form, Therapeutic T Cell Collection Prescription and Therapeutic Stem Cell Collection Prescription, will be submitted as required\r\n* In the case of a related donor: The identified donor must be the original donor whose stem cells were used for the research participant's allogeneic stem cell transplantation (alloSCT)\r\n* For both related and unrelated donors: The donor's hepatitis B surface antigen must be negative and the hepatitis C antibody must be nonreactive; in the case of a positive hepatitis C antibody result, the hepatitis C virus (HCV) viral polymerase chain reaction (PCR) will have to be performed and the results should be negative
The patient's HCT donor has not been previously infected by or sensitized to CMV (e.g. a cord blood transplant or a marrow or PBSC transplant from a seronegative donor).
DONOR ELIGIBILITY: Donor evaluation and eligibility will be assessed as per current City of Hope standard operating procedure (SOP)
DONOR: Medical history and physical examination confirm good health status as defined by institutional standards (see Lurie Children’s Hospital of Chicago Stem Cell Transplant Program policy VII-B entitled Allogeneic Donor Identification, Evaluation, Education, Consent and Management)
DONOR: 6/6 HLA identical family donor
DONOR: Weight > 20 kg (in so far that the weight difference between recipient and donor does not exceed a reasonable likelihood of being able to obtain an adequate cell dose from the donor within two aphereses)
DONOR: Hemoglobin S >= 50%, or beta thalassemia intermediate
MATCHED RELATED DONOR: A donor who is lactating must be willing and able to interrupt breast-feeding or substitute formula feeding for her infant during the period of filgrastim administration and for two days following the final dose
HAPLOIDENTICAL RELATED DONOR: HIV infection
HAPLOIDENTICAL RELATED DONOR: Chronic active hepatitis B; donor may be hepatitis core antibody positive
The majority of patients on this protocol will have autologous peripheral blood stem cells (PBSCs) available; where a syngeneic donor is available, this donor may also be utilized; in the case of a patient who has received a prior allogeneic transplant, if the donor is available, allogeneic stem cells may be utilized; for these patients, 3 criteria must be met: 1) there must be no evidence of graft vs. host disease (GVHD), 2) the patient must be on no medication for GVHD treatment or prophylaxis and 3) there must be full donor chimerism (> 95% donor on peripheral blood chimerism testing); the only acceptable allogeneic product is CD34-selected PBSC (which will minimize the risk of GVHD)
Donor (donor anti-recipient) ABO incompatibility if an ABO compatible donor is available
DONOR: If more than one preferred donor is identified from the above list and there is no medical reason to prefer one of them, then the following guidelines are recommended:\r\n* If the patient is male, choose a male donor\r\n* Choose the youngest preferred donor\r\n* If the patient and family express a strong preference for a particular donor, use that one
DONOR: Donor screening; all donors will meet the standard blood donor criteria established by the participating local blood center, American Association of Blood Banks (AABB)
DONOR: Infectious disease testing will be done per Hemacare policy and AAAB guidelines
DONOR: Donor and intended recipient red cell type and compatibility will be determined
DONOR: Personal or family history of severe sickle cell disease or variant (unless donor has tested negative); testing for the presence of hemoglobin S is not required
DONOR: History of coronary disease
DONOR: Donor must be a human leukocyte antigen (HLA)-haploidentical relative selected for best NK alloreactivity, defined as having a KIR gene present on the donor NK cells for which the relevant HLA haplotype (KIR ligand) is absent in the recipient and present in the donor or selected on the basis of activating KIR gene content
DONOR: Donor must meet standard institutional eligibility and donor certification criteria for therapeutic cell product donation
DONOR: Donor must be Epstein–Barr virus (EBV) or cytomegalovirus (CMV) seropositive
DONOR: Donor must be age 18 or older
DONOR: Active infectious hepatitis
DONOR: Significant medical conditions (e.g. immunosuppressive therapy) that would make the donor an unsuitable T cell donor
DLI DONOR: The patient’s stem cell donor 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 selection process will be compliant with 21 Code of Federal Regulations (CFR) 1271
DLI DONOR: Donor must not have any medical condition which would make apheresis more than a minimal risk procedure, and should have the following:\r\n* No evidence of heart failure or hemodynamically significant arrhythmia\r\n* Bilirubin and hepatic transaminases =< 2.5 x upper limit of normal (ULN)\r\n* Adequate hematologic parameters including a hematocrit > 35% for males and 33% for females, white blood cell count of >= 3,000, and platelets >= 80,000\r\n* Donor safety testing as per institutional practice
DLI DONOR: National Marrow Donor Program (NMDP) donors meet donor eligibility for the study
DONOR: Each donor must meet criteria outlined by institutional policies
EBV-specific T-cells from donor of the patient's transplant are not available
Patients developing EBV lymphomas or lymphoproliferative disorders following an allogeneic hematopoietic progenitor stem cell transplant (HSCT) (ie: marrow, peripheral blood stem cell [PBSC], or umbilical cord blood); in these cases, the HSCT donor, if EBV-seropositive, will be used as the donor of EBV-specific T-cells for adoptive immunotherapy wherever possible, because the EBV-LPD are almost invariably derived from that marrow donor; these patients will be enrolled onto protocol Institutional Review Board (IRB) # 95-024; however, if the HSCT donor is EBV seronegative or not readily available (e.g. a cord blood transplant), the patient will be a candidate to receive EBV-specific T-cells generated from a third party seropositive donor that have been generated and stored in the Memorial Sloan Kettering Cancer Center (MSKCC) bank of cryopreserved immune T-cells for adoptive cell therapy; for these patients, the third party donor derived T cells to be used will be selected primarily on the basis of 1) matching for, at least, 2 HLA antigens and 2) one restricted allele shared by the transplant donor and recipient; however, priority is given to T cells partially HLA antigen matched with, and restricted by, HLA alleles of the transplant donor, since EBV + lymphomas in HSCT recipients are usually (but not always) derived from the transplant donors' cells
DONOR: Known EBV seronegative
DONOR: The patient's HSCT donor, or if HSCT donor is not available a third party donor, must consent to a leukapheresis or whole blood donation(s) obtained at one or more phlebotomies which, in aggregate, will total approximately 250 ml for adults and no more than 5 ml/kg per draw from pediatric donors
DONOR: Donor must not be HLA identical to the recipient
Evidence of mixed chimerisms (less than 95% donor cells) OR
MATCHED RELATED DONOR: Ability to give informed consent; for donors < 18 years of age, he/she must be the oldest eligible donor, their legal guardian must give informed consent, the donor must give verbal assent, and he/she must be cleared by social work and a mental health specialist to participate
MATCHED RELATED DONOR: A donor who is lactating must be willing and able to interrupt breast-feeding or substitute formula feeding for her infant during the period of filgrastim administration and for two days following the final dose
MATCHED UNRELATED DONOR: The evaluation of donors shall be in accordance with existing National Marrow Donor Program (NMDP) Standard Policies and Procedures; general donor inclusion criteria specified in the NMDP Standards (22nd edition)
HAPLOIDENTICAL RELATED DONOR: At least one normal DOCK8 allele demonstrated by a CLIA-certified lab in a sibling donor
HAPLOIDENTICAL RELATED DONOR: Subjects will also undergo the Donor Health History Screen to determine donor eligibility using standard Department of Transfusion Medicine (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: Subjects will undergo follow-up evaluation within 1 week of donation
HAPLOIDENTICAL DONOR: HIV infection
HAPLOIDENTICAL DONOR: Chronic active hepatitis B; donor may be hepatitis core antibody positive
HAPLOIDENTICAL DONOR: Other medical contraindications that in the opinion of the PI constitute exclusion as a donor; 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; 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
HAPLOIDENTICAL DONOR: Mutation of DOCK8 on both alleles in a sibling donor
-  INCLUSION CRITERIA:\n\n          -  Recipient:\n\n               -  Patients diagnosed with one of the following hematologic diseases which are\n                  associated with reasonable longevity, shown to be curable by allogeneic BMT but\n                  where concern for a high procedural mortality with conventional BMT may delay or\n                  prevent such treatment:\n\n                    -  1) Paroxysmal nocturnal hemoglobinuria (PNH) associated with\n                       life-threatening thrombosis, and/or cytopenia, and/or transfusion dependence\n                       and/or recurrent and debilitating hemolytic crisis\n\n                    -  2) Severe aplastic anemia (SAA) or pure red cell aplasia (PRCA [acquired or\n                       congenital]) associated with transfusion dependence and/or neutropenia in\n                       patients who are not candidates for, or who have failed immunosuppressive\n                       therapy\n\n                    -  3) Refractory anemia (RA) or RARS MDS patients who have associated\n                       transfusion dependence and/or neutropenia.\n\n               -  Ages 4 to 80 (both inclusive), and weight >18kg\n\n               -  Availability of HLA identical or single HLA locus mismatched family donor or\n                  10/10 matched unrelated donor at the allelic level (HLA alleles A, B, C, DR, and\n                  DQ).\n\n               -  9/10 donors where all the HLA sequences have the same antigen/peptide binding\n                  domains in key exons to the patient. This can result in identical protein\n                  sequences between patient and donor. Allele mismatches in p and g groups can be\n                  considered acceptable due to the exact matching which exists in the binding\n                  domains.\n\n               -  Telomere Length Testing\n\n               -  Germline/Inherited gene panel in patients where a suspicion for a familial bone\n                  marrow failure syndrome (BMFS) exists, TERC and TERT mutations testing will be\n                  performed on protocol 04-H-0012 or performed elsewhere prior to enrolling on\n                  04-H-0012.\n\n        EXCLUSION CRITERIA:\n\n        -Recipient: any of the following\n\n          -  Major anticipated illness or organ failure incompatible with survival from PBSC\n             transplant\n\n          -  Diffusion capacity of carbon monoxide (DLCO) <40% predicted (patients under the age of\n             10 may be excluded from this criterion if they have difficulty performing the test\n             correctly and thus are unable to have their DLCO assessed) using DL Adj and DL/VA/Adj.\n\n          -  Left ventricular ejection fraction <40% (evaluated by ECHO) or <30% (evaluated by\n             MUGA)\n\n          -  Serum creatinine greater than 2.5mg/dl or creatinine clearance less than 50 ml/min by\n             24 hr urine collection\n\n          -  Serum bilirubin greater than 4 mg/dl, transaminases greater than 5 times the upper\n             limit of normal\n\n          -  Pregnant or lactating\n\n          -  Fanconi s anemia\n\n          -  ECOG performance status of 3 or more (See Bone & Marrow Transplant Consortium\n             Supportive Care Guidelines for HSCT Recipients)\n\n          -  Other malignant diseases liable to relapse or progress within 5 years, with the\n             exception of a separate hematologic malignancy where allogeneic stem cell transplant\n             has been shown to be potentially curative.\n\n          -  Presence of an active infection not adequately responding to appropriate therapy.\n\n          -  Inability to comprehend the investigational nature of the study and provide informed\n             consent. The procedure will be explained to subjects age 8 -17 years with formal\n             consent being obtained from parents or legal guardian.\n\n        INCLUSION CRITERIA:\n\n        -Related Donor:\n\n          -  HLA identical or single HLA mismatched family donor\n\n          -  Age greater than or equal to 4 and less than or equal to 80 years old\n\n          -  Weight > 18 kg\n\n          -  If there is a suspicion of familial BMFS in the recipient, then the donor must have\n             underong genetic testing for genes associated with BMFS -performed at a CLIA-certified\n             laboratory, prior to enrolling in this protocol.\n\n        EXCLUSION CRITERIA:\n\n        -Related Donor: any of the following\n\n          -  Pregnant or lactating\n\n          -  Unfit to receive filgrastim (G-CSF) or undergo apheresis (history of stroke, MI,\n             unstable angina, uncontrolled hypertension, severe heart disease or palpable spleen)\n\n          -  HIV positive (donors who are positive for HBV, HCV or HTLV-I/II, T.cruzi [Chagas] may\n             be used at the discretion of the investigator following counseling and approval from\n             the recipient)\n\n          -  Sickling hemoglobinopathies including HbSS or HbSC. Donors with HbAS are acceptable\n\n          -  Inability of donor or guardian of donor to comprehend the investigational nature of\n             the study and provide informed consent.\n\n          -  Screening test positive for Chagas disease (Trypanosoma cruzi /T.\n             cruzi/trypanosomiasis) confirmed by the Center for Disease Control (CDC).\n\n        INCLUSION CRITERIA & EXCLUSION CRITERIA: Unrelated Donor\n\n        -The NMDP unrelated donor inclusion criteria will be used as outlined in document (link).\n        Donor eligibility will be completed per NMDP standards and in accordance with most recent\n        and stringent FDA guidelines.
DONOR: Each donor must meet criteria outlined by institutional guidelines
DONOR: Donor should agree to undergo general anesthesia and bone marrow harvest collection if peripheral blood stem cell (PBSC) yield is inadequate or otherwise not transplantable for whatever reason
Recipients of unrelated donor transplants from a National Marrow Donor Program (NMDP) Center must sign a release of information form to authorize NMDP transfer of information to the NIH
Previous allogeneic donor must be willing and available to donate again
DONOR: Donor selection will be in accordance with NIH/CC Department of Transfusion Medicine (DTM) criteria and, in the case of an unrelated donor from a Transplant Center, the National Marrow Donor Program (NMDP) standards; when a potentially eligible recipient of an unrelated donor product from an NMDP Center is identified, the recipient will complete an NMDP search transfer request to allow NIH NMDP staff to contact the NMDP Coordinating Center, who will, in turn, contact the donor’s prior Donor Center; the NMDP Policy for Subsequent Donation Requests will be followed and the appropriate forms (Subsequent Donation Request form and Therapeutic T Cell Collection Prescription) will be submitted as required
DONOR: Donor-recipient pairs in which the HLA-mismatch is only in the host-versus-graft (HVG) direction
DONOR: A positive anti-donor cytotoxic crossmatch
Inability to obtain a suitable donor
DONOR: donor selection will follow the Children’s Memorial Hospital Stem Cell Transplant Program policy VII-B entitled Allogeneic Donor Identification, Evaluation, Education, Consent and Management in the Stem Cell Transplant Standard Operating Manual
DONOR: if the donor is unrelated, Children's Memorial Hospital will follow the National Marrow Donor Program (NMDP) protocol for hematopoietic progenitor cells-apheresis (HPC-A) or HPC-marrow (M) (bone marrow) procurement
Inability to find a suitable donor for the patient
No available histocompatible related donor
Minor (donor anti-recipient) ABO incompatibility if an ABO compatible donor is available
Prior transfusions from donor or recipient alloimmunization vs. donor cells
DONOR: Donor must have a hemoglobin S < 50%
Lack of suitable conventional donor (i.e. 5/6 or 6/6 related or 5/6 or 6/6 unrelated donor) or presence of a rapidly progressive disease not permitting time to identify an unrelated donor
Donor cells should be collected and frozen before conditioning starts
DONOR: The donor must not be an exception to standard donor National Marrow Donor Program (NMDP) selection criteria except the donor may be over 55 years of age
1. Patients with Adenovirus infections post allogeneic HSCT or with primary\n             immunodeficiencies with:\n\n               -  Increasing or persistent quantitative ADV RT-PCR DNA copies despite two weeks of\n                  appropriate anti-viral therapy and/or\n\n               -  clinical symptoms attributed to adenovirus, including pneumonitis, hemorrhagic\n                  cystitis, colitis, hepatitis AND/OR\n\n               -  Medical intolerance to anti-viral therapies including:\n\n                    -  grade 2 renal insufficiency secondary to cidofovir Consent: Written informed\n                       consent given (by patient or legal representative) prior to any\n                       study-related procedures.\n\n             Performance Status > 30% (Lansky < 16 yrs and Karnofsky > 16 yrs) Age: 0.1 to 30.00\n             years The first 3 patients entered and possibly the next 3 patients entered will be\n             limited to age 12.0 - 30.99 years. See section 9.3.4 for age eligibility in the first\n             6 patients.\n\n             There will be a temporary hold until 45 days after the 3rd patient and possibly the\n             6th patient has received their ADV-CTLs, The study should be reopened for patients of\n             all ages (0.1-30.99 years). (See Section 9.3.4 for instructions)\n\n             Females of childbearing potential with a negative urine pregnancy test\n\n          2. Donor Eligibility Related donor available with a T-cell response to the viral MACS®\n             GMP PepTivator antigen(s) of adenovirus.\n\n               1. Original related allogeneic donor (if AlloHSCT recipient) if available:\n                  confirmatory testing to respond to corresponding MACS GMP Peptivators\n\n               2. Third Party Related Allogeneic Donor: If original donor is not available or does\n                  not have a T-cell response: third party allogeneic donor (family donor > 1 HLA A,\n                  B, DR match to recipient) with a T-cell response at least to the viral MACS® GMP\n                  PepTivator antigen(s) of adenovirus.\n\n             AND Allogeneic donor disease screening is complete similar to hematopoietic stem cell\n             donors (Appendix 1).\n\n             AND Obtained informed consents by donor or donor legally authorized representative\n             prior to donor collection.\n\n          3. Patient exclusion criteria:\n\n        A patient meeting any of the following criteria is not eligible for the present study:\n\n        . Patient with acute GVHD > grade 2 or extensive chronic GVHD at the time of CTL infusion\n        Patient receiving steroids (>0.5 mg/kg prednisone equivalent) at the time of CTL infusion\n        Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to CTL infusion\n        Patient with poor performance status determined by Karnofsky (patients >16 years) or Lansky\n        (patients ?16 years) score ?30% Concomitant enrollment in another experimental clinical\n        trial investigating the treatment of refractory adenovirus infection(s) Any medical\n        condition which could compromise participation in the study according to the investigator's\n        assessment Known HIV infection Female patient of childbearing age who is pregnant or\n        breast-feeding or not willing to use an effective method of birth control during study\n        treatment.\n\n        Known hypersensitivity to iron dextran Patients unwilling or unable to comply with the\n        protocol or unable to give informed consent.\n\n        Known human anti-mouse antibodies
Donor and intended recipient red cell type and compatibility will be determined
DONOR SELECTION
Donor selection criteria in decreasing order of priority:\r\n* Absence of donor-specific HLA antibodies is preferred (negative flow cytometric cross-match assay or the mean fluorescence intensity [MFI of any anti-donor HLA antibody by solid phase immunoassay < 1000); if donor-specific anti-HLA antibodies cannot be avoided, the risks will be discussed with the patient and consenting parent/guardian and options including debulking or deferring transplant will be considered\r\n* The lowest number of mismatches in the host-versus-graft direction is prioritized to minimize graft rejection\r\n* If more than one donor with the same degree of HLA match, absent or equivalent donor-specific anti-HLA antibodies, and equivalent host-versus-graft allele mismatches, the following prioritization will be used:\r\n** Homozygous normal donor is preferable to heterozygote (carrier)\r\n** ABO-compatible donor is preferable to ABO-incompatible donor\r\n** Cytomegalovirus (CMV) status\r\n*** For a CMV seronegative patient, prefer a CMV seronegative donor\r\n*** For a CMV seropositive patient, prefer a CMV seropositive donor\r\n** Younger donor is preferable to older, avoiding those > 55 years of age if possible\r\n** Male donor preferred over nulliparous female donor over multiparous female donor
DONOR: Pregnant donor
DONOR: Factors which place the donor at increased risk for complications from leukapheresis
DONOR: Agree to undergo donor viral screening panel
DONOR: Not pregnant
DONOR: Identical twin
DONOR: Homozygous NOD2 mutation
DONOR: History of a serious disease or disorder that could be adoptively transferred by infusion of donor hematopoietic cells
DONOR: Choice of donor, when more than one donor with the same phenotype is available, will be based on the following factors:\r\n* Age (younger donor preferable) and physical health of the donor\r\n* Cytomegalovirus (CMV) serostatus of donor and patient; preferable combinations are (D- => R-) (D+ => R+)\r\n* ABO blood group of donor and patient
DONOR: Pregnancy
DONOR: Current serious systemic illness
DONOR: Not pregnant
DONOR: Agree to undergo donor viral screening panel
DONOR: Not pregnant
DONOR: Individuals with active infectious hepatitis
Minimum donor chimerism of 10%
DONOR: For donors <18 years of age, he/she must be the oldest suitable donor, their legal guardian must give informed consent, the donor must give verbal assent, and he/she must be cleared by social work and a mental health specialist to participate
DONOR: Adequate peripheral venous access for apheresis or consent to use a temporary central venous catheter for apheresis; donor selection will be in accordance with National Institutes of Health (NIH)/Clinical Center (CC) Department of Transfusion Medicine (DTM) criteria and, in the case of an unrelated donor, the National Marrow Donor Program (NMDP) standards and Food and Drug Administration (FDA) 21 Code of Federal Regulations (CFR) 1271
DONOR: Identical twins will be excluded
DONOR: High risk of inability to comply with protocol requirements as determined by the principal investigator and donor center team
Patients may be transplanted under this protocol using a syngeneic (identical) twin donor
Syngeneic donor
An unrelated donor search is not required for a patient to be eligible for this protocol, or a donor search and donor mobilization may be abandoned if the clinical situation dictates an urgent transplant; clinical urgency is defined as high likelihood that greater 6-8 weeks will be required to proceed to transplant or a low-likelihood of finding a matched, unrelated donor
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
DONOR: Patient and donor pairs homozygous at a mismatched allele are considered a two-allele mismatch, i.e., the patient is A*0101 and the donor is A*0102, and this type of mismatch is not allowed
DONOR: Identical twin
Evidence of residual donor chimerism on most recent analysis (within 4 weeks of enrollment)
DONOR: Considered medically eligible to receive G-CSF (filgrastim) by independent donor physician
DONOR: Pregnancy
DONOR: Patients must have an HLA matched donor as well as standard Seattle Cancer Care Alliance (SCCA) and or National Marrow Donor Program (NMDP)/other donor center criteria for PBSC donation
Eligible NK donor
DONOR: Donor must be able to undergo leukapheresis for total volume of 10-15 liters
DONOR: There is no age restriction for the donor
DONOR: Cardiac risk factors precluding ability to undergo leukopheresis
DONOR: Donor is pregnant
DONOR ELIGIBILITY:
DONOR PRIORITIZATION:
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
DONOR: Excellent health per conventional pre-donor history (medical and psychosocial evaluation)
DONOR: Donor ability to understand and provide informed consent
Donor lymphocytes available or able to be collected
Unlikely to be able to procure additional donor lymphocytes
DONOR: Not suitable for donation according to UW BMT program donor selection SOP
HAPLO-IDENTICAL DONOR: The donor must meet criteria outlined in the Functional Assessment of Cancer Therapy (FACT)-approved standard operating procedure (SOP) for \DONOR EVALUATION AND SELECTION FOR ALLOGENEIC TRANSPLANTATION\ in the Blood and Marrow Transplant Program Manual, document E-1
HAPLO-IDENTICAL DONOR: The donor must be > 25 kg in weight
HAPLO-IDENTICAL DONOR: Medical or physical reason which makes the donor unlikely to tolerate or cooperate with growth factor therapy and leukapheresis
DONOR: Agrees to undergo donor viral screening panel
DONOR: Meets criteria outlined in the Functional Assessment of Cancer Therapy (FACT) approved standard operating procedures (SOP) for \DONOR EVALUATION AND SELECTION FOR ALLOGENEIC TRANSPLANTATION\ in the Blood and Bone Marrow Transplant Program Manual, document E-1
DONOR: Medical or physical reason which makes the donor unlikely to tolerate or cooperate with growth factor therapy and leukapheresis
DONOR: Factors which place the donor at increased risk for complications from leukapheresis or G-CSF (filgrastim) therapy (e.g. autoimmune disease, sickle cell trait, symptomatic coronary artery disease requiring therapy)
DONOR: Platelets > 150 x 10^9/liter
DONOR: Donor age < 75 unless cleared by the principal investigator
DONOR: Donor must consent to peripheral blood stem cell (PBSC) mobilization with G-CSF (filgrastim) and apheresis
DONOR: Identical twin
DONOR: Not pregnant
DONOR: Able and willing to have up to 4 separate apheresis collections
DONOR: Not pregnant
MATCHED RELATED DONOR: Donor selection will be in accordance with NIH/Clinical Center (CC) Department of Transfusion Medicine criteria and must be able to medically endure stem cell collection or as per local institutional guidelines
MATCHED RELATED DONOR: Active malignancy will exclude the donor; any malignancy less than five years post-remission will exclude the donor; non-hematologic malignancies greater than 5 years ago will not exclude the donor; any history of hematologic malignancy will be considered on a case by case basis
DONOR: Donors must meet HLA matching criteria and standard SCCA and/or National Marrow Donor Program (NMDP) or other donor center criteria for PBSC or bone marrow donation
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
DONOR: Donor (or centers) who will exclusively donate marrow
DONOR: Donor must not have any medical condition which would make apheresis and filgrastim (G-CSF) administration more than a minimal risk
DONOR: Hepatic transaminases =< 2.5 x ULN
DONOR: Platelets >= 80,000
DONOR INCLUSION: The donor of WT-1 specific T lymphocytes will be the same donor who provided the patient's hematopoietic stem cell transplant (HSCT)
DONOR INCLUSION: Re-evaluation for this blood donation will be limited to a clinical history, physical examination and blood tests to insure against any new condition which, in the opinion of the donor's physician, precludes the donor from donating the blood required
The patient has a potentially suitable 8/8 donor if they are between the ages of 69-74 years of age or a potentially suitable 8/8 or 7/8 unrelated donor(s) in the National Marrow Registry or other available Registry if they are between the ages of 18-74
DONOR: General donor inclusion criteria specified in the National Marrow Donor Program (NMDP) Standards (20th edition)
DONOR: Donor exclusion will be in accordance with existing NMDP Standards (20th edition)
DONOR: In addition to NMDP donor exclusion criteria, for the purposes of this protocol, donors who are unwilling to donate PBSC and only wish to pursue a bone marrow donation will be excluded; an alternate donor will be selected if possible, but in the event that no alternate donor is available, the patient will be removed from the trial
DONOR: Current treatment with lithium
DONOR: Presence of sickle hemoglobin as demonstrated by appropriate testing such as hemoglobin electrophoresis
DONOR: No contra-indication for the donor to collection by apheresis of mononuclear cells mobilized by G-CSF at a dose of 16 ug/kg of body weight
UNRELATED DONORS: Patient and donor pairs homozygous at a mismatched allele in the graft rejection vector are considered a two-allele mismatch, i.e., the patient is A*0101 and the donor is A*0102, and this type of mismatch is not allowed
DONOR: Identical twin
DONOR: Pregnancy
DONOR: Current serious systemic illness
DONOR: Original donor of hematopoietic cell transplantation
DONOR: Donor must give consent to leukapheresis
DONOR: Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral or subclavian)
DONOR: Donor must be medically fit to undergo the apheresis procedure (institutional guidelines for apheresis)
DONOR: Pregnancy
DONOR: Recent immunization may require a delay
DONOR: HLA genotypically or phenotypically identical related donor
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
DONOR: Identical twin
DONOR: Pregnancy
DONOR: Current serious systemic illness
DONOR: Donor (or centers) who will exclusively donate marrow
DONOR: Identical twin
DONOR: Current pregnancy
DONOR ELIGIBILITY:
Donor is not pregnant
DONOR EXCLUSION:
Donor is pregnant
DONOR:\r\n* Donor eligibility will be determined per standard blood or marrow transplantation (BMT) criteria
DONOR: BMI > 35
DONOR: History of blood product donation to the recipient
DONOR: Significant renal disease
DONOR: Ongoing malignancies
DONOR: Severe local or systemic infection
DONOR: donor must meet all New Brunswick Affiliated Hospitals (NBAH) requirements for hematopoietic stem cell donation, including:
DONOR: no uncontrolled infections, other medical or psychological/social conditions, or medications that might increase the likelihood of patient or donor adverse effects or poor outcomes
MSC DONOR: male sex
DONOR: Agree to undergo donor viral screening panel
Has an available HPC-A donor
ABO compatibility with donor
DONOR: History of blood product donation to recipient
Peripheral blood neutrophil chimerism: less than 95% donor
Donor must not have an active infection at the time of study entry.
DONOR: A donor who is lactating must substitute formula feeding for her infant during the period of cytokine administration
DONOR: History of hypertension that is not controlled by medication, stroke, or severe heart disease; individuals with symptomatic angina will be considered to have severe heart disease and will not be eligible to be a donor
Puget Sound Blood Center Recipient Donor Battery Panel
DONOR ELIGIBILITY
Must meet the criteria for donor selection defined in the Standard Operating Procedures of University Hospitals Seidman Cancer Center Stem Cell Transplant Program (SOP B6.00 Allogeneic Donor Selection, Evaluation, and Management)
Original transplant utilized an unrelated donor graft
DONOR: Pregnant donor
Availability of an unrelated donor, identified and screened by the National Marrow Donor Program (NMDP); the donor will have at least 7/8 human leukocyte antigen (HLA)-A, -B, -C and –DRB1 matching by high resolution molecular typing and will meet NMDP eligibility criteria to serve as a peripheral blood stem-cell donor
DONOR: Hypersensitivity to atorvastatin
DONOR: Pregnancy
DONOR: Nursing mother
DONOR: Current serious systemic illness
DONOR: Donor evaluation and eligibility will be assessed as per current City of Hope SOP
mBP donor collection that meets protocol specifications;
Female candidate for renal transplant, expected to undergo transplant surgery >= 30 days and =< 12 months after enrollment\r\n* For potential participants on the institutional waiting list for deceased donor transplant, a study clinician confirms the candidate is likely to receive a transplant within the next 12 months, taking into account the candidate’s priority on the waiting list, age, medical status, institutional policies, and scores like the Estimated Post-Transplant Survival (EPTS) Score and Calculated Panel Reactive Antibody (CPRA) percentage, etc\r\n* For potential participants expected to undergo a living donor transplant, one or more donor(s) have been identified and is/are in work-up (even though all work-up status may or may not be complete); a study clinician confirms the living donor transplant is likely to be scheduled within the next twelve months after taking into account donor work-up progress, age and medical status, and institutional policies\r\n** Note: the study was originally restricted to participants who were expecting to receive only living donor renal transplants; however, less than a third of kidney transplants in the United States occur with kidneys from living donors; a majority of transplants are in the setting of donation of kidneys from deceased donors; to permit efficiencies in accrual, the study is amended to also open enrollment to recipients of deceased donor kidneys
DONOR: Sickling hemoglobinopathy including HbSS, HbAS, HbSC
Suitable donor - Medically cleared to donate per National Marrow Donor Program (NMDP)
DONOR
Among several potential donors, will choose in order of priority:\r\n* Matched cytomegalovirus (CMV) IgG serologic status between donor and recipient\r\n* ABO-matched donor preferred, then minor ABO mismatch, then major ABO mismatch\r\n* Younger donor preferred: child, then sibling, and then parent\r\n* For male recipient, male donor will be preferred; avoid mother as a donor unless no other choices
One of following donor graft sources:\r\n* sibling donor\r\n* haploidentical donor (with post-transplant cyclophosphamide)\r\n* unrelated donor\r\n* unrelated umbilical cord blood
DONOR ELIGIBILITY
DONOR: unrelated donors will be identified through the National Marrow Donor Program (NMDP) or equivalent donor search organization
DONOR: Hypersensitivity to atorvastatin
DONOR: Pregnancy
DONOR: Nursing mother
DONOR: Current serious systemic illness
ABO compatibility with donor
Lack of suitable conventional donor (i.e. 7/8 or 8/8 related or 7/8 or 8/8 unrelated donor) or presence of rapidly progressive disease not permitting time to identify an unrelated donor
Unrelated Donor Transplant
DONOR: Individuals not donating stem cells
Stable donor cell chimerism in at least 3 consecutive tests prior to treatment.
If the subject had allogeneic HCT for a malignant disease, the subject should have complete donor chimerism. (*complete donor chimerism determined by the investigator per site's standards)
Availability of eligible donor material
DONOR: Provides written consent
Absence of donor specific HLA antibodies
DONOR: For a partially HLA-mismatched transplant, the patient must lack antibodies against donor HLA molecules; specifically, complement dependent cytotoxicity and flow cytometric crossmatch assays must be negative, and the mean fluorescence intensity (MFI) of any anti-donor HLA antibody by solid phase immunoassay should be < 3000; consult with Immunogenetics for the clinical significance of any anti-donor antibody; desensitization to remove anti-donor antibody should only be performed for patients who have no other donor options
Have evidence of recipient donor specific anti-HLA antibodies.
Anti-donor HLA antibodies. Additional exclusion criteria:
Presence of anti-donor HLA antibodies (positive anti-donor HLA antibody is defined as a positive cross-match test of any titer by complement-dependent cytotoxicity or flow cytometric testing or the presence of anti-donor HLA antibody to the high expression loci HLA-A, B, C, DRB1, or DPB1 with mean fluorescence intensity (MFI) > 1000 by solid phase immunoassay).
Recipient HLA antibodies against donor HLA
Presence of donor-specific antibodies against chosen graft source
Suitable related haploidentical donor identified:\r\n* Must be matched at least at 5 of 10 HLA antigens (A, B, C, DRB1, DQ)\r\n* Must not be matched at more than 7 of 10 HLA antigens\r\n* Recipient should not have HLA antibodies to potential donor; if the recipient does have HLA antibodies to the potential donor, an alternative donor is preferred; however, if there are no suitable alternative donors, the donor to whom the patient has HLA antibodies can be utilized as long as the antibody titer is less than 2000 median fluorescence intensity (MFI); if the titer is > or = to 2000 MFI, the recipient must undergo successful antibody desensitization prior to enrollment on this study; any patients who have demonstrated donor specific antibodies will not be evaluated for the end points measured in this study but will be followed for treatment related toxicities\r\n* Haploidentical donors that are ABO compatible with the recipient are preferred; Minor ABO incompatibility is preferred to major ABO incompatibility; major ABO incompatibility between recipient and donor is the least preferred but still acceptable for this study\r\n* It is preferred that the haploidentical donor must be available to donate on day -1 and day 0 at Roswell Park Cancer Institute (RPCI), so that fresh product can be processed by the RPCI stem cell lab and administered to the patient on day 0; while less preferable, cryopreserved product may be utilized on this protocol
Patients with donor specific HLA antibodies with a titer greater than 2000 MFI (whether or not they have undergone a desensitization protocol)
Presence of donor directed HLA antibodies
DONOR: Absence of pre-existing donor-specific anti-HLA antibodies (DSA) in the recipient; Patients with pre-existing DSA could undergo desensitization per City of Hope (COH) standard operating procedures [SOP] and should have DS < 2000 prior to conditioning at discretion of principal investigator (PI)
DONOR: Positive anti-donor HLA antibody
Presence of anti-donor HLA antibodies (positive anti-donor HLA antibody is defined as a positive cross-match test of any titer by complement-dependent cytotoxicity or flow cytometric testing or the presence of anti-donor HLA antibody to the high expression loci HLA-A, B, C, or DRB1 with mean fluorescence intensity [MFI] > 1000 by solid phase immunoassay)
Presence of donor specific antibodies (DSA) with mean fluorescence intensity (MFI) of > 2000 as assessed by the single antigen bead assay, < 6 weeks prior to starting transplant conditioning
DONOR: Recipient derived anti-donor HLA antibodies identified as “unacceptable\ by Luminex assay; exceptions may be made by the Director of the Histocompatibility Laboratory in conjunction with the recipient’s physician and a plan for desensitization
DONOR: Positive anti-donor HLA antibody
DONOR: Lack of recipient anti-donor HLA antibody; Note: in some instances, low level, non-cytotoxic HLA specific antibodies may be permissible if they are found to be at a level well below that detectable by flow cytometry; this will be decided on a case-by-case basis by the principal investigator (PI) and one of the immunogenetics directors
Positive patient anti-donor HLA antibody, which is deemed clinically significant.
DONOR: Lack of recipient anti-donor HLA antibody; Note: in some instances, low level, non-cytotoxic HLA specific antibodies may be permissible if they are found to be at a level well below that detectable by flow cytometry; this will be decided on a case-by-case basis by the PI and one of the immunogenetics directors; pheresis to reduce anti-HLA antibodies is permissible; however eligibility to proceed with the transplant regimen would be contingent upon the result
DONOR: Positive anti-donor HLA antibody
Positive leukocytotoxic crossmatch; specifically, complement dependent cytotoxicity and flow cytometric crossmatch assays must be negative, and the mean (or median) fluorescence intensity (MFI) of any anti-donor HLA antibody by solid phase immunoassay should be < 2000; if a screening assay against pooled HLA antigens is used, positive results must be followed with specificity testing using a single antigen assay; the MFI must be < 2000 unless the laboratory has validated higher threshold values for reactivity for HLA antigens, such as HLA-C, DQ, and DP, that may be enhanced in concentration on the single antigen assays; consult with principal investigator (PI) for the clinical significance of any anti-donor antibody
Lack of recipient anti-donor HLA antibody\r\n* Note: in some instances, low level, non-cytotoxic HLA specific antibodies may be permissible if they are found to be at a level well below that detectable by flow cytometry; this will be decided on a case-by-case basis by the principal investigator (PI) and one of the immunogenetics directors; pheresis to reduce anti-HLA antibodies is permissible; however eligibility to proceed with the transplant regimen would be contingent upon the success of the desensitization
Class I or II antibodies against donor HLA antigens
DONOR: Recipient derived anti-donor high-titer (> 3000 MFI) HLA antibody as determined by Luminex assay
No donor-specific antibodies (DSA) using solid phase micro particle technology (by Luminex phenotype panel or Luminex single antigen bead test) performed 30 days or less prior to transplant; as assessed by local laboratories; a positive anti-donor HLA antibody test is defined as the presence of an antibody against any one of the high expression HLA molecules (HLA-A, -B, -C, or –DRB1) with a mean fluorescence intensity (MFI) > 1000 by solid phase immunoassay
Negative T and B cell flow crossmatches with the designated donor; as assessed by local laboratories; if one or more of the crossmatches is positive, the participant will be considered a screen failure unless combined results of antibody and cross match testing implicate a non-HLA antibody as the cause of the positive flow crossmatch; in this case, the protocol chair must approve the participant as a screening success after consultation with the HLA laboratory director
Anti-donor HLA antibody using solid phase micro particle technology (by Luminex phenotype panel or Luminex single antigen bead test) performed 30 days or less prior to transplant as assessed by local laboratories; the director of the immunogenetics laboratory will be responsible for determining what level of antibody is considered a positive anti-donor HLA antibody result
DONOR; Lack of recipient anti-donor HLA antibody\r\n* Note: In some instances, low level, non-cytotoxic HLA specific antibodies may be permissible if they are found to be at a level well below that detectable by flow cytometry; this will be decided on a case-by-case basis by the PI and one of the immunogenetics directors; pheresis to reduce anti-HLA antibodies is permissible; however eligibility to proceed with the transplant regimen would be contingent upon the success of the desensitization
DONOR: lack of recipient anti?donor HLA antibody\r\n* Note: in some instances, low level, non?cytotoxic HLA specific antibodies may be permissible if they are found to be at a level well below that detectable by flow cytometry; this will be decided on a case?by?case basis by the principal investigator (PI) and one of the immunogenetics directors; pheresis to reduce anti?HLA antibodies is permissible; however eligibility to proceed with the transplant regimen would be contingent upon the success of the desensitization
Presence of antibodies to a mismatched donor HLA antigen
Absence of donor-specific antibodies (DSA) to the mismatched HLA-locus
Patient will be screened for antibodies targeting mismatched HLA antigens in potential haploidentical donors (donor specific antibodies, DSA); antibody screen and confirmatory testing using Luminex single antigen-bead test will be done
Baseline positive donor-specific anti-HLA antibody testing
Known presence of HLA antibodies against the non-shared donor haplotype
Known presence of HLA antibodies against the non-shared donor haplotype
Recipients with donor sensitive antibodies (DSA), defined by 2000 or higher median fluorescence intensity (MFI) against one or more class I or II antigens
Patients with related or unrelated donors for whom the best available donor is: a) mismatched at antigen level for any single class I locus (HLA-A, -B, -C) +/- an additional class I mismatch at the allele level OR mismatched at the allele level for any 2 class I loci (if typed at the molecular level) OR mismatched at the antigen or allele level for class II loci HLA-DRB1 and/or – DQB1; must be matched for at least one DRB1 allele and one DQB1 allele; b) there is a likelihood of rapid disease progression while HLA typing and results of a preliminary search and the donor pool suggests that a 10/10 HLA-A, B, C, DRB1 and DQB1 matched donor will not be found; c) there is no HLA-A, -B or -C one locus allelic mismatched donor available
DONOR: Related or unrelated volunteer donors who are mismatched with the recipient within one of the following limitations:\r\n* Mismatch for one HLA class I antigen with or without an additional mismatch for one HLA-class I allele, but matched for HLA-DRB1 and HLA-DQ, OR\r\n* Mismatched for two HLA class I alleles, but matched for HLA-DRB1 and HLA-DQ, OR\r\n* HLA class I HLA-A, -B, -C allele matched donors allowing for any one or two DRB1 and/or DQB1 antigen allele mismatch
HLA-mismatch at the HLA-A, -B, -C, and - DRB1 loci. Note, HLA-DQ mismatches are permissible
DONOR: HLA mismatched or haploidentical related donors (including 1st degree relatives and half siblings)\r\n* The donor and recipient must be identical at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1; a minimum match of 5/10 is therefore required, and will be considered sufficient evidence that the donor and recipient share one HLA haplotype
DONOR: When more than one donor is available, the donor with the lowest number of HLA allele mismatches will be chosen, unless there is HLA cross-match incompatibility or a medical reason to select otherwise, in which case donor selection is the responsibility of the principal investigator (PI), in consultation with the immunogenetics laboratory; in cases where there is more than one donor with the least degree of mismatch, donors will be selected based on the most favorable combination of (i) HLA compatibility in cross-match testing and (ii) ABO compatibility; will prioritize the lowest number of mismatches in the host-versus-graft (HVG) direction (to potentially minimize graft rejection risk)
Patients with a related donor who is identical for one HLA haplotype
DONOR: Related donors who are identical for one HLA haplotype
Additional Patient Inclusion Criteria for Patients Assigned to Haploidentical BM Arm: Patients must be HLA typed at high resolution using DNA based typing at the following HLA-loci: HLA-A, -B, -C and DRB1 and have available a related haploidentical BM donor with 2, 3, or 4 HLA-mismatches. A unidirectional mismatch in either the graft versus host or host versus graft direction is considered a mismatch. The donor and recipient must be HLA identical for at least one antigen (using high resolution DNA based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C, and HLA-DRB1. Fulfillment of this criterion shall be considered sufficient evidence that the donor and recipient share one HLA haplotype, and typing of additional family members is not required.
HLA haplo first degree relatives of the patient including biological parents, siblings or half siblings, or children with 2, 3, or 4 mismatches using DNA-based typing. A unidirectional mismatch in either the graft versus host or host versus graft direction is considered a mismatch. The donor and recipient must be identical at a minimum of one allele (at high resolution DNA-based typing) at the following genetic loci: HLA-A, -B, -C, and DRB1.
A minimum genotypic identical match of 4/8 is required, as determined by high resolution typing, at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, and HLA- DRB1.
Available related donor who is CMV+ and HLA-haploidentical or better but not fully HLA-matched
Patients must be human leukocyte antigen (HLA) typed at high resolution using deoxyribonucleic acid (DNA) based typing at HLA-A, -B, -C and DRB1 and have an available related haploidentical bone marrow donor with 2, 3, or 4 (out of 8) HLA-mismatches; a unidirectional mismatch in either the graft versus host or host versus graft direction is considered a mismatch
HLA-MISMATCHED UNRELATED DONOR: Unrelated volunteer donors who are mismatched with the recipient within one of the following limitations:\r\n* Mismatch for one HLA class I antigen with or without an additional mismatch for one HLA-class I allele, but matched for HLA-DRB1 and HLA-DQ, OR \r\n* Mismatched for two HLA class I alleles, but matched for HLA-DRB1 and HLA-DQ\r\n* HLA class I HLA-A, -B, -C allele matched donors allowing for any one or two DRB1 and/or DQB1 antigen/allele mismatch
DONOR: Donor preference based on KIR/KIR ligand mismatch\r\n* In addition to HLA determination, KIR genotyping will be performed on potential donors; when more than one potential donor is available, preference will be given to the donor who demonstrates KIR incompatibility with recipient HLA class I ligands defined as the donor expressing a KIR gene for which the corresponding HLA class I ligand is not expressed by the recipient; KIR genotyping and HLA class I typing will be performed in the University of Wisconsin HLA laboratory; if all potential donors show the same degree of KIR/KIR-ligand mismatch, donors will be preferentially selected based on B haplotype KIR gene content
Availability of at least one HLA- haploidentical (i.e. >= 5/10 and =< 8/10 HLA match) related donor (HLA-A, B, C, DR, and DQ loci) who is available to donate CD34+ cells
HLA identical (6/6) related donor available and readily accessible at time of transplantation evaluation
Patient must have available one or more potential first (biologic mother, sister, half-sister, or daughter) or second-degree related female donor; mothers and daughters have a 100% chance of being haploidentical matches, sisters a 75% chance of being matched or haploidentical, and second degree relatives have a 50% chance of being haploidentical matches; the donor and recipient must be HLA identical for at least one antigen at HLA-A, -B, -C and HLA-DRB1
Patients and selected donor must be HLA typed at high resolution using deoxyribonucleic acid (DNA) based typing at the following HLA-loci: HLA-A, -B, -C and DRB1; donors must be HLA-haploidentical relatives including, but not limited to, children, siblings, or parents, defined as having a shared HLA haplotype between donor and patient at HLA-A, -B, -C, and -DRB1
DONOR: Partially HLA-mismatched relative (allele level matched at 4 to 7 of 8 HLA loci: -A, -B, -C, and -DRB1)
DONOR: \r\n* HLA haploidentical relative of the patient; a unidirectional mismatch in either the graft versus host or host versus graft direction is considered a mismatch; the donor and recipient must be identical at least one allele (high resolution DNA-based typing) at the following genetic loci: HLA-A, -B, -C, and DRB1 \r\n* If patient over age 25 years, may use HLA identical sibling donor\r\n* If patient has inherited bone marrow failure syndrome (IBMFS) and clear evidence of same disorder in potential related donors, unrelated donor may be used; unrelated donor must be a 10/10 match using HLA-A, -B, -C, DRB1, and DPB1; unrelated donor may also be used in case of donor specific antibodies to related donors or other clinical causes of unsuitable related donors
DONOR: HLA-haploidentical donor/recipient match by molecular typing at the HLA-A, HLA-B and HLA-DRB1 loci
DONOR: In addition to HLA determination, KIR genotyping will be performed on potential donors; preference will be given to donors who demonstrate KIR incompatibility with recipient HLA class I ligands defined as the donor expressing a KIR gene for which the corresponding HLA class I ligand is not expressed by the recipient; KIR genotyping and HLA class I typing will be performed in the University of Wisconsin HLA laboratory; the following KIR genes and corresponding HLA class I ligands will be analyzed:\r\n* KIR Gene; HLA Class I Ligand\r\n* KIR3DLI; HLA Bw4\r\n* KIR2DL1; HLA C^LYS80\r\n* KIR2DL2/3; HLA C^ASN80\r\nIf all potential donors show the same degree of KIR/KIR-ligand mismatch, donors will be preferentially selected based on B haplotype KIR gene content according to the method described by Cooley et al., using the donor KIR B-content group calculator
DONOR: Donor with full haplotype HLA-mismatch will be preferred (4 out of 8 HLA match) to maximize graft-versus-leukemia (GVL)
Cord blood units available through National Marrow Donor Program (NMDP) with the following minimal criteria;\r\n* HLA Match: 4/6 or better match (HLA A, B, DRB1)\r\n* Cell dose: minimum of 2 x 10^7 total number of nucleated cells (TNC)/kg pre thaw
There are CMVpp65-specific T-cells available in appropriate doses in the MSKCC Adoptive Immune T-cell Therapy Bank that are matched with the patient for 1 HLA allele and that exhibit CMVpp65-specific cytotoxic activity that is restricted by an HLA allele shared by the patient
DONOR: HLA matching criteria
HAPLOIDENTICAL RELATED DONOR: A haploidentical donor is a related donor that shares one haplotype in common with the recipient such that HLA compatibility will be a minimum of 5 out of 10 HLA loci matched; the HLA loci to be tested will be HLA A, B, Cw, DRB1, and DQB1; a minimum number of mismatches is desirable; however if several options are available the selection of a donor will be based on the loci where the mismatch occurs and the relative importance of its potential immunological function; donor-recipient pairs will initially be typed molecularly to provide a low resolution typing (antigen-level) to aid in the selection of the potential donor; upon review of the familial inheritance pattern, a qualified HLA staff member will review haplotype inheritance; high resolution (allele level) typing will be performed; final selection of a donor will be in consultation with National Cancer Institute (NCI) physicians and qualified HLA personnel; haploidentical related donors for pediatric recipients must be 6 years of age or older; if more than one haploidentical related donor is available, we will evaluate each donor individually according to overall health, ABO matching, cytomegalovirus (CMV), etc. to select the donor
Presence of a suitable first-degree related, human leukocyte antigen (HLA)-haploidentical or HLA-matched bone marrow donor\r\n* The donor and recipient must be identical at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1; a minimum match of 5/10 is therefore required, and will be considered sufficient evidence that the donor and recipient share one HLA haplotype
Availability of a related or unrelated donor with a 7/8 or 8/8 match for HLA-A, B, C, and DRB1.
Patients with acquired immunodeficiency syndrome (AIDS) developing EBV lymphomas or lymphoproliferative diseases as a consequence of the profound acquired immunodeficiency induced by human immunodeficiency virus (HIV); for such patients, EBV specific T-cells from third party seropositive donors who are HLA compatible in 1) at least 2 HLA antigens and 2) one restricted allele shared by the patient will be used; selection of T cells known to be restricted by an HLA allele shared by the patient will be given priority
Patients must have an HLA-identical related or HLA-matched unrelated donor
Absence of a suitable partially HLA-mismatched (haploidentical), first-degree related donor; Note: determination of matching is based on allele or allele group level typing; to be considered haploidentical, the donor and recipient must be identical at least one allele of each of the following genetic loci: HLA-A, -B, -Cw, -DRB1, and –DQB1; a minimum match of 5/10 is therefore required, and will be considered sufficient evidence that the donor recipient share one HLA haplotype; donors who are homozygous for the CCR5delta32 polymorphism are given preference
DONOR: The donor and recipient must be identical at least 5 HLA alleles based on high resolution typing of HLA-A, -B, -Cw, -DRB1, and -DQB1, with at least one allele matched for a HLA class I gene (HLA-A, -B, or -Cw) and at least one allele matched for a class II gene (HLA-DRB1 or -DQB1)
HAPLOIDENTICAL RELATED DONOR: A haploidentical donor that shares one haplotype in common with the recipient such that HLA compatibility will be a minimum of 5 out of 10 HLA loci matched; the HLA loci to be tested will be HLA A, B, Cw, DRB1, and DQB1; a minimum number of mismatches is desirable; however if several options are available the selection of a donor will be based on the loci where the mismatch occurs and the relative importance of its potential immunological function; donor-recipient pairs will initially be typed molecularly to provide a low resolution typing (antigen-level) to aid in the selection of the potential donor; upon review of the familial inheritance pattern, a qualified HLA staff member will review haplotype inheritance; high resolution (allele-level) typing will be performed; final selection of a donor will be in consultation with National Cancer Institute (NCI) physicians and qualified HLA personnel; if more than one haploidentical related donor is available, we will evaluate each donor individually according to overall health, ABO matching, cytomegalovirus (CMV), etc. to select the donor
DONOR: Related donors who are genotypically identical for one HLA haplotype and who may be mismatched at the HLA-A, -B, -C or DRB1 loci of the unshared haplotype with the exception of single HLA-A, -B or -C allele mismatches
Have a related or unrelated human lymphocyte antigen (HLA) -identical donor or one antigen/allele mismatched in HLA-A, B, C or DRB1
Recipients with unrelated donor matched at the HLA A, B, DRBI loci, or if < 35 years mismatched at a single HLA A or B, or DRBI locus
DONOR: When more than one HLA-haploidentical donor is available, the donor with the lowest number of HLA allele mismatches will be chosen, unless there is HLA cross-match incompatibility, in which case donor selection is the responsibility of the project investigator (PI), in consultation with the immunogenetics laboratory; in cases where there is more than one donor with the least degree of mismatch, donors will be selected based on the most favorable combination of (i) HLA compatibility in cross-match testing and (ii) ABO compatibility:
Available HLA-genotypically identical related donor
No existing HLA-identical related donor is available
Related donors that are matched at HLA 7-8/8 loci (HLA A, B, C, and DRB1 loci) by intermediate resolution
Unrelated donors that are matched at HLA 8/8 (HLA A, B, C, and DRB1 loci); 1 allele/antigen mismatch at HLA-A, -B, -C, or DRB1 may be considered if no other suitable donor available
Inclusion Criteria:\n\n          1. Signed informed consent\n\n          2. Patients with one of the life-threatening hematological malignancies:\n\n               -  Acute lymphocytic leukemia (ALL) in CR1 with high-risk features including adverse\n                  cytogenetics such as t(9;22), t(1;19), t(4;11), or MLL gene rearrangements;\n                  greater than 1 cycle to achiever remission or with persistent MRD; ALL in second\n                  or greater remission with or without MRD. Acute myeloid leukemia (AML) in CR1\n                  with high-risk features defined as: Greater than 1 cycle of induction therapy\n                  required to achieve remission; Preceding myelodysplastic syndrome (MDS) or\n                  myeloproliferative disease; Presence of FLT3 mutations or internal tandem\n                  duplications; FAB M6 or M7 classification; Adverse cytogenetics, -5, del 5q, -7,\n                  del7q, abnormalities involving 3q, 9q, 11q, 20q, 21q, 17, +8 [> 3 abnormalities];\n\n               -  AML in second or greater remission, primary induction failure and patients with\n                  relapsed disease;\n\n               -  Advanced chronic myeloid leukemia (CML) who have progressed to blast phase or\n                  accelerated phase and are in need of a transplant and do not have an HLA matched\n                  donor;\n\n               -  MDS with IPSS intermediate-2 or higher or therapy-related MDS.Hodgkin lymphoma or\n                  Non-Hodgkin lymphoma (NHL): relapsed disease where remission duration is less\n                  than 1 year, relapse after previous autologous transplant, or failure to achieve\n                  CR with chemotherapy.\n\n          3. Age ? 18 years and ? 65 years\n\n          4. Deemed eligible for allogeneic stem cell transplantation\n\n          5. Lack of suitable conventional donor (i.e. 8/8 related or unrelated donor) or presence\n             of rapidly progressive disease not permitting time to identify an unrelated donor\n\n          6. HLA typing will be performed at high resolution (allele level) for the HLA-A, -B, Cw,\n             and DRBl loci\n\n               -  A minimum genotypic identical haplotype match of 4/8 is required\n\n               -  The donor and recipient must be identical, as determined by high resolution\n                  typing, at least one allele of each of the following genetic loci: HLA-A, HLA-B,\n                  HLA-Cw, and HLA- DRB1\n\n          7. Subjects with adequate organs function as measured by:\n\n               -  Cardiac: Left ventricular ejection fraction at rest must be >45%\n\n               -  Pulmonary: FEV 1, FVC, DLCO (diffusion capacity) > 50% predicted (corrected for\n                  hemoglobin); or O2 saturation > 92% on room air\n\n               -  Hepatic: Direct bilirubin ? 3 x upper limit of normal (ULN), or AST/ALT ? 5 x ULN\n\n               -  Renal: Serum creatinine within normal range for age or creatinine clearance, or\n                  with a recommended GFR ? 50 mL/min/1.73m2\n\n          8. Performance status: Karnofsky ? 80%\n\n        Exclusion Criteria:\n\n        Subjects meeting the following criteria are NOT eligible for the study:\n\n          1. HLA 8/8 allele matched (HLA-A,-B,-Cw,-DRBl) related or unrelated donor able to donate;\n\n          2. Autologous hematopoietic stem cell transplant ? 3 months prior to enrollment;\n\n          3. Prior allogeneic transplantation;\n\n          4. Active CNS involvement by malignant cells (less than 2 months from the conditioning);\n\n          5. Current uncontrolled bacterial, viral or fungal infection (currently taking medication\n             with evidence of progression of clinical symptoms or radiologic findings); the PI is\n             the final arbiter of this criterion;\n\n          6. Positive HIV serology or viral RNA (? Grade III per CTCAE criteria);\n\n          7. Pregnancy (positive serum or urine ?HCG test) or breast-feeding;\n\n          8. Fertile men or women unwilling to use effective forms of birth control or abstinence\n             for a year after transplantation;\n\n          9. Bovine product allergy.\n\n         10. Severe obesity (patient's weight is >/= 1.5x the donor weight).
DONOR: Institutional guidelines for HLA-match may be followed as long as the minimum criteria for HLA-matching as above are met
Match-specific criteria:\r\n* HLA mismatched or haploidentical related donors: The donor and recipient must be haploidentical at a minimum of one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1\r\n* Donor-specific anti-HLA antibody testing requirement: Testing for antibodies targeting donor specific HLA antigens at HLA-A, B, C, DRB1, DQ and DP will be completed as per institutional standards\r\n* When more than one donor is available, the donor with the lowest number of HLA allele mismatches will be chosen, unless there is an HLA cross-match incompatibility or a medical reason to select otherwise, in which case donor selection is the responsibility of the principal investigator (PI); in cases where there is more than one donor with the least degree of mismatch, donors will be selected based on the most favorable combination of the factors below
Myelodysplastic syndrome (MDS) with < 5% blasts by morphology and meets at least one of the following:\r\n* Received intensive induction chemotherapy (i.e. 7+3 or mitoxantrone, etoposide, and cytarabine [MEC]) OR\r\n* Progression after 4 cycles of hypomethylating agents \r\n** The donor and recipient must be human leukocyte antigen (HLA) identical for at least one haplotype (using high resolution deoxyribonucleic acid [DNA] based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C, and HLA-DRB1
DONORS: HLA-haploidentical related donor (aged 18 to 75 years) where donor and recipient must be HLA identical for at least one haplotype (using high resolution DNA based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C, and HLA-DRB1
DONOR: Appropriate HLA-match to patient
Availability of a human leukocyte antigen (HLA) matched (6/6) sibling donor or 8/8 matched unrelated donor; Donors with mismatch at HLA-A, HLA-B, HLA-C, and HLA-DR will be reviewed by matched unrelated donor (MUD) committee and allowed if their mismatch with the recipient does not require additional GVHD prophylaxis (other than tacrolimus and sirolimus), donors with mismatch at HLA-DQ or HLA-DPB are eligible; donor evaluation according to City of Hope (COH) standard operating procedure (SOP)
Patients must have a first-degree related donor or half-sibling who is at minimum HLA haploidentical to be enrolled; the donor and recipient must be identical at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1; a minimum match of 5/10 is therefore required, and will be considered sufficient evidence that the donor and recipient share one HLA haplotype
The donor and recipient must be identical, as determined by high resolution typing, on at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA- DRB1 and HLA-DQB1.
HLA-identical related or HLA-matched unrelated donor available
Partially HLA-mismatched unrelated donor: HLA typing will be performed at high resolution (allele level) for the HLA-A, -B, -C, and -DRB1 loci; a minimum match of 4/8 at HLA-A, -B, -C, and -DRB1 is required
Have 8/8 allele-level, related or unrelated, medically cleared HSC donor matching at human leukocyte antigen (HLA)-A, HLA-B, HLA-C, and DRB-1
Presence of a suitable related, HLA-haploidentical or HLA-matched stem cell donor\r\n* The donor and recipient must be identical at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1; a minimum match of 5/10 is therefore required for related donors, and will be considered sufficient evidence that the donor and recipient share one HLA haplotype
Donors must be either:\r\n* HLA-haploidentical or HLA-identical relatives of the patient based on allele or allele group level typing
DONOR: Haploidentical 1st-degree relative as defined by 3/6 or 4/6 HLA-matched at HLA -A, -B, or –DRB1 who is 18-70 years of age
HLA-Mismatched Related and Unrelated Donors: Patients who do not have an HLA-matched donor but have a related or unrelated donor who have one antigen or one allele mismatch at the HLA A, B, C, DRB1 or DQB1 loci; or who have two mismatches, at HLA-DQB1 and at one other locus will be eligible for entry on this protocol
Available related donor that is at least an allele level haplotype-match at human leukocyte antigen (HLA)- A, B, C, DRB1 and DPB1 loci (DPB1 matching according to the “permissive – non-permissive” dichotomy as stated by University of Wisconsin [UW] Histocompatibility Laboratory); a minimum match of 5/10 loci is required; an unrelated donor search is not required for a patient to be eligible for this protocol
HAPLO-IDENTICAL DONOR: A HLA-haplo-identical related donor will be selected as available as per standard MSKCC adult bone marrow transplantation (BMT) guidelines; mismatched family members who are matched at more than 5 of 10 HLA-loci are permitted; factors to be taken into account when selecting a haplo-identical donor will include donor age, weight, health status and comorbidities, compliance, venous access, recipient donor specific HLA-antibody status, and natural killer (NK) cell alloreactivity
Donor/Recipient HLA Matching:
HLA-mismatched related and unrelated donors: \r\n* Patients who do not have an HLA-matched donor but have a related or unrelated donor who have one antigen or one allele mismatch at the HLA A, B, C, DRB1 or DQB1 loci; or who have two mismatches, at HLA-DQB1 and at one other locus, will be eligible for entry on this protocol
DONOR: Related, HLA-haploidentical donors who are identical for one HLA haplotype and mismatched for any number of HLA-A, -B, -C, DRB1 or DQB1 loci of the unshared haplotype
Patients must have a related donor who is identical for one human leukocyte antigen (HLA) haplotype and mismatched at the HLA-A, -B or class II, DR beta 1 (DRB1) loci of the unshared haplotype with the exception of single HLA-A, -B or DRB1 mismatches
DONOR: Related donor who is identical for one HLA haplotype and mismatched at the HLA-A, -B, or DRB1 loci of the unshared haplotype with the exception of single HLA-A, -B, or DRB1 mismatches
RELATED DONORS: When more than one potential donor exists, priority should be given to donors based on HLA identity > cytomegalovirus (CMV) seronegativity > ABO compatibility > sex matching\r\n* Donor who is HLA phenotypically or genotypically identical at the allele level at HLA-A, -B, -C, -DRB1, and -DQB1\r\n* Must consent to G-CSF administration and leukapheresis; \r\n* Must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian);\r\n* Only G-CSF mobilized PBMC only will be permitted as a hematopoietic stem cell (HSC) source on this protocol
Available human leukocyte antigen (HLA)-matched or -haploidentical, living related donor who is willing to donate bone marrow and part of liver; the donor and recipient must be HLA identical for at least one allele (using high resolution deoxyribonucleic acid [DNA] based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C and HLA-DRB1; fulfillment of this criterion shall be considered sufficient evidence that the donor and recipient share one HLA haplotype
Recipient of a first renal allograft from a human leukocyte antigen (HLA)-haploidentical, living related donor; the donor and recipient must be HLA identical for at least one allele (using high resolution deoxyribonucleic acid [DNA] based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C, and HLA-DRB1; fulfillment of this criterion shall be considered sufficient evidence that the donor and recipient share one HLA haplotype
DONOR: HLA-haploidentical, first-degree relatives or half-siblings of the recipient participant at the allele or allele group; the donor and recipient must be HLA identical for at least one allele (using high resolution DNA based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C and HLA-DRB1; fulfillment of this criterion shall be considered sufficient evidence that the donor and recipient share one HLA haplotype
Presence of a suitable first-degree related, HLA-haploidentical or HLA-matched bone marrow donor;\r\n* The donor and recipient must be identical at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1; a minimum match of 5/10 is therefore required, and will be considered sufficient evidence that the donor and recipient share one HLA haplotype
DONOR: Donors must be HLA-haploidentical or HLA-identical, first-degree relatives of the patient based on allele or allele group level typing; half-siblings are not permitted
Positive patient anti-donor lymphocyte crossmatch in HLA-A or B mismatched transplants; the definition of match is in Section 2.2.1; the crossmatch would only apply to mismatches at HLA-A or B, not DRB1 or HLA-C
Related donor of T cells must be at least partially human leukocyte antigen (HLA) compatible, matching with recipient in at least 3/6 HLA loci (HLA-A, HLA-B, and HLA-DRB1 loci will be considered for this)\r\n* Donor selection priority: The original donor will be the first choice as source of T cells; If the original donor is unavailable for donation of peripheral mononuclear cells or does not meet all donor eligibility criteria, alternative related donors will be selected, with preference for those who have full HLA matching in 6/6 loci over those with partial HLA matching (>= 3/6 HLA loci)
Presence of a suitable related, HLA?haploidentical or HLA?matched stem cell donor or unrelated matched donor\r\n* The donor and recipient must be identical at least one allele of each of the following genetic loci: HLA?A, HLA?B, HLA?Cw, HLA?DRB1, and HLA?DQB1; a minimum match of 5/10 is therefore required for related donors, and will be considered sufficient evidence that the donor and recipient share one HLA haplotype; unrelated donors will be 10/10
DONOR: donors must be either:\r\n* HLA?haploidentical or HLA?identical relatives of the patient based on allele or allele group level typing\r\n* Unrelated donor who is a 10/10 match to the recipient
If a haploidentical donor is considered, parents, children, full siblings and in selected cases, extended family, will have high resolution typing at the MCC HLA laboratory; a familiar haploidentical donor is chosen among those who share at least one HLA-A, B, C, DRB1 and DQB1 haplotype with the patient
UNRELATED DONOR: an HLA 7/8 or 8/8 HLA A, B and C (class I) and HLA DRB1 (class II) alleles, or 9/10 or 10/10 HLA A, B and C (class I) and HLA DRB1 and DQB1 (class II) alleles will be required for study entry
Patient plans on receiving stem cells from a donor who has a 3 or more HLA mismatch
Haploidentical family donor with 2 to 3 mismatches at the HLA-A, -B and/or -DR loci of the unshared haplotype
HLA typing will be performed at high resolution (allele level) for the HLA-A, -B, Cw, and DRBl, and loci. A minimum match of 5/10 is required. The donor and recipient must be identical, as determined by high resolution typing, at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, and HLA- DRB1.
Patients for whom the best available donor is mismatched at both HLA class I and class II
DONOR: If the patient is homozygous at the mismatch HLA class I locus or II locus, the donor must be heterozygous at that locus and one allele must match the patient (i.e., patient is homozygous A*01:01 and donor is heterozygous A*01:01, A*02:01); this mismatch will be considered a one-antigen mismatch for rejection only
DONOR: Patients who are homozygous at the mismatched HLA class I locus or II locus, the donor is excluded if homozygous at the mismatched locus (i.e., patient is homozygous A*01:01 and donor is homozygous A*02:01); this type of mismatch is considered a two-antigen mismatch and is not allowed
HLA-haploidentical related donor (aged 12 to 70 years)
DONOR: Patients who are homozygous at the mismatched HLA class I or II locus, the donor is excluded if homozygous at the mismatched locus (i.e., patient is homozygous A *01:01 and donor is homozygous A *02:01); this type of mismatch is considered a two-antigen mismatch and is not allowed
HLA-MISMATCHED UNRELATED DONOR: If the patient is homozygous at the mismatch HLA class I locus or II locus, the donor must be heterozygous at that locus and one allele must match the patient (i.e., patient is homozygous A*01:01 and donor is heterozygous A*01:01, A*02:01); this mismatch will be considered a one-antigen mismatch for rejection only
Available HLA-matched or better but not fully HLA-matched (2/4 or 3/4 antigens) related donor (aged 18 to 75 years) with donor/recipient match based on a minimum of intermediate resolution deoxyribonucleic acid (DNA) based class I typing of the A and B locus who is cytomegalovirus (CMV) seropositive
DONOR: Haploidentical by human leukocyte agent (HLA)-typing\r\n* Haploidentical family members, between the ages of 18 and 65 years, identified as an eligible donor by HLA-typing.; a biological parent will generally be used as the donor
Available human leukocyte antigen (HLA)-matched or better but not fully HLA-matched (2/4 or 3/4 antigens) related donor (aged 18 to 75 years) with donor/recipient match based on a minimum of intermediate resolution deoxyribonucleic acid (DNA) based class I typing of the A and B locus who is CMV seropositive
Human leukocyte antigen (HLA)-haploidentical related donor (aged 12 to 75 years) with donor/recipient match based on a minimum of intermediate resolution deoxyribonucleic acid (DNA) based class I typing of the A and B locus (at least 2/4 class I allele)
HLA-haploidentical related donor (aged 12 to 75 years) with donor/recipient match based on a minimum of intermediate resolution DNA based class I typing of the A and B locus (at least 2/4 class I allele)
Available HLA-haploidentical or mismatched related donor (aged 12 to 70 years) with donor/recipient match based on a minimum of intermediate resolution deoxyribonucleic acid (DNA) based class I typing of the A and B locus (at least 2/4 class I allele)
DONOR: HLA-haploidentical or mismatched related donor/recipient match based on a minimum of intermediate resolution DNA based Class I typing of the A and B locus (at least 2/4 class I allele)
DONOR: Donor is blood-related and HLA-haploidentical to the recipient
Available human leukocyte antigen (HLA)-haploidentical donor that meets the following criteria:\r\n* Related donor (sibling, offspring, or offspring of sibling)\r\n* At least 18 years of age\r\n* HLA-haploidentical donor/recipient match by at least class I serologic typing at the A&B locus\r\n* In general good health, and medically able to tolerate leukapheresis required for harvesting the NK cells for this study\r\n* Negative for hepatitis, human T-cell lymphotropic virus (HTLV), and human immunodeficiency virus (HIV) on donor viral screen\r\n* Not pregnant\r\n* Voluntary written consent to participate in this study
DONOR: Evaluation: history and physical examination; laboratory examinations: hematology, electrolytes, chemistry; infectious disease screening and serology; HLA typing; KIR typing will not be indicated if there is only one haploidentical donor; KIR typing is advised to be done if feasible and does not delay transplant
Available related human leukocyte antigen (HLA)-haploidentical NK cell donor by at least class I serologic typing at the A&B locus
DONOR: HLA-haploidentical donor/recipient match by at least class I serologic typing at the A&B locus
Available related human leukocyte antigen (HLA)-haploidentical donor (aged 14 to 75 years) with donor/recipient match based on a minimum of intermediate resolution DNA based class I typing of the A&B locus
DONOR: Donor/recipient match based on a minimum of intermediate resolution DNA based class I typing of the A&B locus
DONOR: HLA-haploidentical donor/recipient match by at least class I serologic typing at the HLA-A and B loci
DONOR: Donor is blood-related and HLA-haploidentical to the recipient
Available related human leukocyte antigen (HLA)-haploidentical donor (aged 14-75 years) by at least class I serologic typing at the A & B locus
DONOR: HLA-haploidentical donor/recipient match by at least class I serologic typing at the A & B locus
Available related human leukocyte antigen (HLA)-haploidentical donor by at least class I serologic typing at the A&B locus
DONOR: HLA-haploidentical donor/recipient match by at least class I serologic typing at the A&B locus
Available related human leukocyte antigen (HLA) haploidentical NK cell donor by at least Class I serologic typing at the A and B locus (age 12-75 years)
DONOR: HLA-haploidentical donor/recipient match; if time permits and multiple donors are available, preference will be given to the KIR ligand mismatched donor (as predicted by HLA typing)
Has a confirmed suitable HLA haploidentical donor available
Available human leukocyte antigen (HLA)-haploidentical donor that meets the following criteria:\r\n* Immediate family member (sibling, offspring, or parent)\r\n* HLA-haploidentical donor/recipient match by class I serologic typing at the A&B locus\r\n* In the treating physician’s opinion, is in general good health, and medically able to tolerate leukapheresis required for harvesting hematopoietic stem cells (HSC)\r\n* No active hepatitis (B, C), human T-cell lymphotropic virus (HTLV), and human immunodeficiency virus (HIV) infections\r\n* Not pregnant