DONOR: Donors who are HIV-positive and/or, medical conditions that would result in increased risk for G-CSF mobilization and harvest of PBSC
Patients and donors must be able to sign consent forms (or if a minor the parent will sign); donors should be willing to donate
DONOR: Donors must meet the selection criteria as defined by the Foundation for the Accreditation of Hematopoietic Cell Therapy (FAHCT) and will be screened per the American Association of Blood Banks (AABB) (AABB guidelines and the recipients will be informed of any deviations)
DONOR: Donor parity and sex mismatch, have also been associated with an increased risk of acute GVHD (aGVHD) and decreased survival in some but not all studies; donor age and weight should be also taken into consideration\r\n* Suggestions (in no order of priority):\r\n** Younger (18 years of age or older) and lighter donors should be preferred\r\n* If all else is equal, male donors may be preferred over nulliparous female donors who may be preferred over multiparous female donors\r\n* Other factors such as donor age and health history will be integrated into the donor selection process per standard practice and may be prioritized over HLA, ABO and CMV status; children donors may be used if appropriate
DONOR: Donors who do not fulfill criteria as apheresis donors as established by institutional guidelines
DONOR: HIV-positive donors
DONOR: Unrelated donors must be >= 18 as per National Marrow Donor Program (NMDP) guidelines
DONOR: Related donors will be selected from the patient’s family members and relatives; preference will be given to related donors over the age of 18 whenever possible; if minor donors are to be enrolled, they will be a minimum of 12 years old
DONOR: Related donors must meet all requirements to donate as per Lucile Packard Children's Hospital (LPCH) standard of procedure (SOP) for donors
DONOR: Related donors for recipients who have monogenetic mutations must be unaffected; for recipients with de novo mutations, testing of related donors is largely not required, but is recommended in all cases and is required when the donor is the child of the recipient; mutation testing needs to be performed by a CLIA-certified lab, if such testing is available; for donors who carry one mutated allele of a PID which is inherited in either an autosomal recessive or X-linked fashion, the donor must have no discernable symptomatology or penetrance of the mutation suggesting that they are affected carriers; this should be verified through disease-appropriate quantitative and functional assays to assess the function of the potential donor’s immune system (e.g. whole blood EBV DNA quantitative polymerase chain reaction [qPCR], natural-killer group 2, member D [NKG2D] activity, T, B, and natural killer cells [TBNK] panel, and quantitative immunoglobulin levels for a female carrier of the magnesium transporter 1 [MAGT1] mutation that causes X-linked immunodeficiency with magnesium defect, Epstein-Barr virus infection, and neoplasia [XMEN]); furthermore, the X-chromosome inactivation pattern should be assessed for female carriers of X-linked diseases if they are considered as potential donors to confirm favorable and complete lyonization of hematopoietic cells; for PIDs inherited in an autosomal dominant fashion, donors who have one mutated allele for the recipient’s disease will be considered ineligible to donate, regardless of the donor’s phenotype; additional blood tests may be required to assess for quantitative and/or qualitative defects in the donor’s immune system, particularly in cases where PID mutation testing is not available or the PID mutation is not identified\r\n* A NIAID protocol (07-I-0033, Detection and Characterization of Infections and Infection Susceptibility, PI: Steve Holland) is already in place and will handle all the genetic/genomic analysis for recipients and potential donors on this protocol, including the management of results, genetic counseling, and education
DONOR: Related donors undergoing bone marrow harvest should be deemed fit for the operative procedure and related donors undergoing apheresis should be deemed fit for the collection procedure
DONOR: Related donors will undergo the donor health history screen by skilled staff in the Blood Services Section for adult donors and age-appropriate questioning when indicated for pediatric donors to determine donor eligibility using standard Department of Transfusion Medicine (DTM) criteria
DONOR: Unrelated donors will be evaluated in accordance with existing National Marrow Donor Program (NMDP) Standard Policies and Procedures except for the additional requirement of EBV serostatus testing; note that participation in this study is offered to all unrelated donors but not required for clinical donation, so it is possible that not all unrelated donors will enroll on this study
DONOR: Donors unwilling to donate PBSC
Unrelated donors donating outside of the United States of America (USA)
HEALTHY VOLUNTEER BLOOD DONORS
DONOR: PBSC is the preferred cell source (when feasible) for fully matched donors; PBSC may also be used for a mismatched donor following discussion with the PI; bone marrow is allowed when PBSC is not feasible or as determined by the PI
DONOR: Both arms: All donors in both arms should be evaluated and approved by DSC
DONOR: Donors who are HIV-positive and/or, medical conditions that would result in increased risk for G-CSF mobilization and harvest of peripheral blood stem cell (PBSC)
DONOR: Ability of donors < 18 years of age to undergo bone marrow harvest
DONOR: Donors must meet the selection criteria prior to the start of the recipient’s pre-transplant conditioning regimen as defined by the Foundation for the Accreditation of Cell Therapy (FACT) and will be screened according to the American Association of Blood Banks (AABB) guidelines and University of Wisconsin Bone Marrow Transplant (UW BMT) program Standard Operating Procedure (SOP)
Potential donors under the age of 18 must have a single patient exemption approved by the Institutional Review Board (IRB); the donor must provide assent and the donor’s parent or guardian must provide permission for minor participation; donors under the age of 18 who cannot assent based on their developmental stage will not be included
DONOR: For younger donors, no more than 20 mL bone marrow may be harvested per kg of donor body weight
RESEARCH PHASE INCLUSION CRITERIA:\r\nDONOR: Verification of donor eligibility (clearance must be received from the NMDP)\r\n* Donors are evaluated by NMDP affiliated donor centers per NMDP Standards\r\n** Donors who are medically suitable, but ineligible by Food and Drug Administration (FDA) guidelines may still donate peripheral blood stem cells (PBSC) with documentation of urgent medical need by the PI\r\n** Patients who receive stem cell products from ineligible donors will be informed of any increase in risk of transfusion-related diseases prior to initiation of conditioning chemotherapy\r\n* Donors who are ineligible or unwilling to donate bone marrow will not be eligible to donate to study recipients; however, in the event that the patient has already begun conditioning chemotherapy and a donor PBSC collection is terminated early for donor-related medical concerns, a bone marrow graft may be infused; should this occur, the recipient will be removed from the study, but will continue to be managed on this protocol for all transplant-related care and complications\r\n* Inadequate stem cell collection from the selected donor is defined as less than or equal to 2 x 10^6 cluster of differentiation (CD)34+ cells/kg; in most cases, donor cell collections are infused fresh; if a fresh collection is found to have an inadequate cell count, the cells will still be infused, but the recipient will be removed from the study, and managed clinically for all transplant-related care and complications on this protocol; if the patient fails to engraft, the donor may be requested for a second collection or an emergency bone marrow harvest at the discretion of the PI and NMDP Medical Director; in the event of an inadequate collection obtained prior to patient conditioning, the donor may be asked to donate a second time, or another eligible donor may be requested
DONOR: Male donors will be preferred to avoid reactivity against H-Y minor histocompatibility antigens and associated risk of risk of acute GvHD, especially grafts from multiparous women
DONOR: Younger donors will be preferred
DONOR: Haploidentical-(related) donor’s age should be 4-60 years and weigh > than 20 kg; general preference of related haplo-identical marrow HSC donors prioritizes male relatives over female relatives and younger age balanced with size and ease/safety of marrow collection
MATCHED UNRELATED DONOR: The evaluation of donors shall be in accordance with existing National Marrow Donor Program (NMDP) Standard Policies and Procedures
DONOR: Donors must meet the selection criteria as defined by the Foundation for the Accreditation of Hematopoietic Cell Therapy (FACT)
DONOR: Donors will be selected from among the subject’s relatives, adult children preferred
Must have donor peripheral blood stem cells mobilized by National Marrow Donor Program (NMDP) standards; no bone marrow donors
DONOR: If donors do not meet institutional guidelines, exclusion will be considered
Severe alloimmunization with inability to guarantee a supply of adequate PRBC donors
DONORS: Donors in groups 1 and 2 would have already been determined to be eligible and will have donated blood or leukocytes to establish EBV-specific T-cells under IRB # 05-065, 07-055, 95-024, or 12-086; there are no additional eligibility requirements for these donors
DONORS: Donors in group 3, however, will need to meet the following eligibility requirements prior to donation:\r\n* Donors must satisfy the criteria specified in Food and Drug Administration (FDA) 21 Code of Federal Regulations (CFR) 1271\r\n* Donors must be typed for HLA-A, B, C, and DR\r\n* Donors must have a hemoglobin value > 10 g/dl\r\n* Donors must be capable of undergoing, at least, a single standard 2 blood volume leukapheresis or a donation of one unit of whole blood
DONOR: Serologic testing for transmissible disease will be performed as per institutional guidelines adopted from extant National Marrow Donor Program (NMDP) and Foundation for Advancement in Cancer Therapy (FACT) guidelines; donors should be considered eligible to donate leukapheresis or blood based on these guidelines (i.e. blood donation guidelines)
DONOR: Potential donors consist of:\r\n* Unrelated donors\r\n* Second-degree relatives\r\n* First cousins
MATCHED RELATED DONORS: Matched related donors that will have their cells collected via apheresis will also undergo the donor health history screen to determine donor eligibility using standard DTM criteria in the Dowling Apheresis Clinic by skilled staff in the Blood Services Section for adult patients and age-appropriate questioning when indicated for pediatric subjects
HAPLOIDENTICAL RELATED DONOR: Adult related donors would be preferred over related donors who are minors
DONOR: Donors will be excluded if for medical or psychological reasons they are unable to tolerate the procedure of peripheral stem cell donation
DONOR: If donors do not meet institutional guidelines, exclusion will be considered
DONOR: History of hypertension that is not controlled by medication, stroke, or severe heart disease (donors with symptomatic angina will be excluded); donors with a history of coronary artery bypass grafting or angioplasty who are symptom free will receive a cardiology evaluation and be considered on a case-by-case basis
DONOR: Donors must not be pregnant
DONOR: Anemia (Hb < 11 gm/dl) or thrombocytopenia (platelets < 100,000 per ul); however, potential donors with Hb levels < 11 gm/dl that is due to iron deficiency will be eligible as long as the donor is initiated on iron replacement therapy; the NIH Clinical Center, Department of Transfusion Medicine/NMDP physicians will determine the appropriateness of individuals as donors
DONOR: Ability of donors < 18 years of age to undergo apheresis without use of a vascular access device; vein check must be performed and verified by an apheresis nurse prior to arrival at the Seattle Cancer Care Alliance (SCCA)
DONOR: Donors must meet the selection criteria as defined by the Foundation for the Accreditation of Cell Therapy (FACT) and will be screened per the American Association of Blood Banks (AABB) guidelines
DONOR: In the case that PBMC will be used as stem cell source, ability of donors < 18 years of age to undergo apheresis without use of a vascular access device; vein check must be performed and verified by an apheresis nurse prior to arrival at the Seattle Cancer Care Alliance (SCCA)
DONOR: all donors will have to meet the standard infectious diseases criteria (Children’s Memorial Hospital Stem Cell Transplant Program policy VII-B entitled Allogeneic Donor Identification, Evaluation, Education, Consent and Management) and study-specific infectious disease criteria prior to study entry
DONOR: Donors will be < 55 years of age and in good health as approved by the National Marrow Donor Program (NMDP) donor and collection centers; related donors will be < 70 years of age
Patients and donors must be able to sign consent forms; partially mismatched (at least haploidentical) first degree relative should be willing to donate
DONOR: Donors must meet the selection criteria as defined by the Foundation for the Accreditation of Hematopoietic Cell Therapy (FAHCT) and will be screened per the American Association of Blood Banks (AABB); (AABB guidelines and the recipients will be informed of any deviations)
Related donors will be assessed and collected through University of Minnesota BMT protocol MT2012-14C: “Procedure Guidelines For Related Hematopoietic Stem Cell Donors.”
Donor screening; all donors will meet the standard blood donor criteria established by the participating local blood center, American Association of Blood Banks (AABB)
Donors will be selected from among the subject’s relatives, adult children preferred
Donors regardless of match and selection criteria must:\r\n* Not be affected by the same disease making the patient eligible for alloHCT; disease carriers may be permitted depending on the clinical situation\r\n* Meet donor criteria as outlined in University of Minnesota protocol MT2012-14C: Procedure Guidelines for Related Hematopoietic Stem Cell Donors
DONOR: Donors weighing less than 40 kg (children) will need evaluation by a pediatrician for suitability of the apheresis procedure
DONOR: Donors able to undergo peripheral blood stem cell collection or bone marrow harvest
DONOR: Weight >= 15 kilograms and for unrelated donors, >= 18 years
DONOR: For donors >= 18 years of age, ability to give informed consent
Donors: Identical twin
Donors: Pregnancy
DONOR:\r\n* First-degree relative with genotypic identity at 6/6 HLA loci (HLA- A, B, and DR)\r\n* Age 11 to 90 years and able to give consent or assent; for donors < 18 years old, the legal guardian must be able to provide informed consent\r\n* Adequate venous access for peripheral apheresis, or consent to use a temporary central venous catheter for apheresis\r\n* Donors must be human immunodeficiency virus (HIV) negative\r\n* Donors with a history of hepatitis B or hepatitis C infection may be eligible; however, eligibility determination of such patients will require a hepatology consultation; the risk/benefit of the transplant and the possibility of transmitting hepatitis will be discussed with the patient and eligibility will then be determined by the principal investigator and LAI\r\n* Lactating donors must substitute formula feeding for her infant during period of filgrastim administration (to prevent any filgrastim effect on infant)
DONOR:\r\n* History of psychiatric disorder which may compromise compliance with transplant protocol, or which does not allow for appropriate informed consent\r\n* History of hypertension that is not controlled by medication, stroke, autoimmune disease, or severe heart disease (donors with symptomatic angina will be excluded); donors with a history of coronary artery bypass grafting or angioplasty who are symptom free will receive a cardiology evaluation and be considered on a case-by-case basis\r\n* History of prior malignancy; however, cancer survivors who have undergone potentially curative therapy may be considered for stem cell donation on a case-by-case basis; in addition, donors with localized cancer such as prostate cancer that are on a watch-and-wait management due to the low-risk of disease progression may also be considered for stem cell donation on a case-by-case basis; the risk/benefit of the transplant and the possibility of transmitting viable tumor cells at the time of transplantation will be discussed with the patient\r\n* Donors must not be pregnant (unknown effect of filgrastim on fetus); donors of childbearing potential must use an effective method of contraception\r\n* Anemia (hemoglobin [Hb] < 11 gm/dl) or thrombocytopenia (platelets < 100,000 per ul); however, potential donors with Hb levels < 11 gm/dl that is due to iron deficiency will be eligible as long as the donor is initiated on iron replacement therapy and the case is individually approved by NIH or Hackensack Blood Bank
DONOR: Donors must meet the selection criteria as defined by the Foundation for the Accreditation of Hematopoietic Cell Therapy (FACT)
DONOR: If there is more than one donor option based on the above criteria, additional suggested criteria to consider (in no order of priority as none of these characteristics have been shown to make a difference in the setting of haploBMT with post-transplantation cyclophosphamide [PT/Cy]) include:\r\n* Younger adults age >= 18 years and non-obese donors should be preferred\r\n* If all else is equal, male donors may be preferred over nulliparous female donors who may be preferred over multiparous female donors\r\n* If all other criteria equal and if the patient and family express a strong preference for a particular donor, that donor should be selected
Cadaveric and donation by cardiac death (DCD) donors (no living donor liver transplantation [LDLT])
Unrelated Donor: Marrow donors
Unrelated Donor: Donors who are HIV-positive and/or medical conditions that would result in increased risk to the donor G-CSF mobilization and G-PBMC collections
DONOR: Marrow donors
DONOR: Donors who are HIV-positive and/or medical conditions that would result in increased risk to the donor filgrastim (G-CSF) mobilization and PBSC collections
DONOR: Considered medically eligible for leukopheresis procedure by independent donor physician (University of Pennsylvania physician who is not the recipient’s primary transplant physician for related donors; physician designated by National Marrow Donor Program for unrelated donors)
DONOR: Unrelated donors donating outside of the United States of America (USA) or Germany
DONOR: Donors must meet the selection criteria prior to the start of the recipient’s pre-transplant conditioning regimen as defined by the Foundation for the Accreditation of Cell Therapy (FACT) and will be screened according to the American Association of Blood Banks (AABB) guidelines and UW Bone Marrow Transplant (BMT) program standard operating procedure (SOP)
DONOR: Donors must be capable of undergoing leukapheresis
DONOR: Female donors must not be pregnant or lactating
DONOR: Donors must not have developed a new malignancy requiring chemotherapy or radiation in the interval since apheresis for transplant
RELATED DONORS:
DONOR: Donor must consent to PBSC mobilization with G-CSF and apheresis as well as collection and donation of plasma; bone marrow unrelated donors are not eligible for this protocol
MATCHED RELATED DONOR: Donors must be physically able to and willing to tolerate marrow harvest collection preferably, or in the absence of this option, able and willing to donate via peripheral blood pheresis
MATCHED UNRELATED DONOR: The evaluation of donors shall be in accordance with existing National Marrow Donor Program (NMDP) Standard Policies and Procedures at all institutions
DONOR: Donors who are HIV-positive and/or, medical conditions that would result in increased risk for G-CSF mobilization and harvest of PBSC
DONOR: Adult donors must be capable of providing informed consent; potential donors under the age of 18 must have a ‘single patient exemption’ approved by the Institutional Review Board (IRB) and the donor and a guardian must provide assent
DONOR: Donors with a known allergy to E. coli-derived products are ineligible for mobilization with G-CSF; alternatives may be used and would have to be discussed individually in these rare circumstances
DONOR: Haploidentical donor selection will be based on standard institutional criteria, otherwise no specific prioritization will be made amongst the suitable available donors; donors will not be selected based on killer cell immunoglobulin-like receptor (KIR) status
DONOR: Donors unable or unwilling to undergo marrow harvest for the initial HCT, storage of autologous blood prior to marrow harvest or apheresis one week after marrow harvest
DONOR: HIV-positive donors
DONOR: The evaluation of donors shall be in accordance with existing NMDP Standard Policies and Procedures
DONOR: Donors who are not suitable for medical reasons to donate peripheral blood mononuclear cells (PBMC) by continuous centrifugation according to the criteria of the American Association of Blood Banks (AABB)
DONOR: Age < 75 years (yrs), older donors may be considered after review at Patient Care Conference
DONOR: Donors must meet the selection criteria as defined by the Foundation for the Accreditation of Cell Therapy (FACT) and will be screened per the American Association of Blood Banks (AABB) guidelines
DONOR: all donors are selected and screened for their ability to provide adequate infection-free apheresis products for the patient
DONOR: donors should be selected based on two principles\r\n* First, a parent or offspring is preferable to siblings\r\n* Second principle is that the donor will optimally have natural killer (NK) cells that express killer immunoglobulin (Ig)-like receptors that are mismatched with the subject’s HLA receptor ligands
DONOR: Donors must meet the selection criteria as defined by the BMT Policy Manual
DONOR: Adult donors must be the same donor used for the non-myeloablative allogeneic transplant and a related family member with a HLA 3-6/6 match with the subject and must be capable of providing informed consent; potential donors under the age of 18 must have a ‘single patient exemption’ approved by the Institutional Review Board (IRB) and the donor and a guardian must provide assent; the donor must be the same donor used for the original allogeneic transplantation; selection of donors will be compliant with 21 Code of Federal Regulations (CFR) 1271
DONOR: Donors will complete the Adult Donor History Questionnaire and have all laboratory studies included in the Donor Referral National Testing Laboratory (NTL) Panel, complete blood count (CBC) with auto or manual differential, and a chemistry panel within 7 days of scheduled collection procedure; donors who were evaluated greater than 1 year prior for transplant collection will also have a history and physical exam, chest x-ray (CXR), and electrocardiogram (EKG) completed; donors must not have any medical condition which would make apheresis more than a minimal risk, and should have normal range laboratory findings; all abnormal laboratory findings will be evaluated by the treating physician within the context of the entire donor assessment process
DONOR: Allogeneic donors must not have HIV infection
DONOR: Donors must not be pregnant; donors of childbearing potential must use an effective method of contraception from the time of study entry until at least one year post-transplant
DONORS IN GROUP 1 (HISTORICAL DONORS): Donors in Group 1 would have already been determined to be eligible and will have donated blood or leukocytes to establish CMV-specific T-cells under Institutional Review Board (IRB) # 05-065, 07-055, 95-024, or 11-130; there are no additional eligibility requirements for these donors
DONORS IN GROUP 2 & 3 (PROSPECTIVE AND VOLUNTEER DONORS): Transplant donors and healthy human leukocyte antigen (HLA) typed volunteers who agree to provide T-cells for third-party donation (groups 2 and 3) will need to meet the following eligibility requirements prior to donation:\r\n* Donors must satisfy the criteria specified in Food and Drug Administration (FDA) 21 Code of Federal Regulations (CFR) 1271\r\n* Donors must be typed for HLA-A, B, C and DR\r\n* Donors must have a hemoglobin value > 10 g/dl\r\n* Donors must be capable of undergoing, at least, a single standard 2 blood volume leukapheresis or a donation of one unit of whole blood
DONOR: Donors with impaired cardiac function are excluded. Electrocardiography is routine for potential HCT donors over 60 years old and those with a history of heart disease. Subjects in whom cardiac function is abnormal (excluding 1st degree branch block, sinus brachycardia, sinus tachycardia or non?specific T wave changes) are ineligible for Triplex vaccination
DONOR: related donors must meet eligibility criteria as per BMT Standard Operating Procedures (SOP) 1002
PBSC donors must meet the same criteria as NMDP marrow donors. These criteria are set forth in NMDP Standards and the Donor Center Manual of Operations.