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