Patients may not have had a prior allogeneic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)
Patients must not have had prior allogeneic bone marrow transplant or double umbilical cord blood transplantation
Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)
Additional Patient Inclusion Criteria for Patients Assigned to Double Umbilical Cord Blood Arm:
DONOR: HLA-matched sibling cord blood exclusions: Any cord blood units without full maternal testing and negative results for hepatitis A, B, C, HIV, and HTLV-1 viruses; any additional available virology results on the unit itself will be reviewed but are not mandated, complete or always available; cord blood units are presumed to be cytomegalovirus (CMV) negative regardless of serologic testing due to passive transmission of maternal CMV antibodies
DONOR: Unrelated Umbilical Cord Blood: The patient and the cord blood unit(s) must be matched for at least 4 of 6 loci as defined above
DONOR: Unrelated Umbilical Cord Blood: Selection of two umbilical cord blood (UCB) units is allowed to provide sufficient cell dose
DONOR: Unrelated Umbilical Cord Blood: Each UCB unit MUST contain at least 1.5 x 10^7 TNC per kilogram recipient weight
DONOR: Unrelated Umbilical Cord Blood: The total cell dose of the combined units must be at least 3.0 x 10^7 TNC per kilogram recipient weight
DONOR: Unrelated Umbilical Cord Blood: Any cord blood units with < 1.5 x 10^7 total nucleated cells per kilogram recipient weight
DONOR: Unrelated Umbilical Cord Blood: Any cord blood units without full maternal testing and negative results for hepatitis A, B, C, HIV, and HTLV-1 viruses; any additional available virology results on the unit itself will be reviewed but are not mandated, complete or always available; cord blood units are presumed to be CMV negative regardless of serologic testing due to passive transmission of maternal CMV antibodies
Patients who have received Y-90 ibritumomab (Zevalin) or I-131 tositumomab (Bexxar), as part of their salvage therapy are not eligible for myeloablative umbilical cord blood transplant
Previous allogeneic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)
Cord blood product manufactured by the NCBP (at least one, if the graft contains more than one units)
Patient with either one or both:\r\n* Two 5/8 HLA or better high resolution matched umbilical cord blood (UCB) grafts with a cell dose of 2.0 x 10^7 total nucleated cell (TNC)/kg each, or\r\n* A related haplo-identical donor
Previous allogenic bone marrow transplant or double umbilical cord blood transplantation
Patients must have two cord blood (CB) units available which are matched with the patient at 4, 5, or 6/6 HLA\r\nclass I (serological) and II (molecular) antigens. Each cord must contain at least 1.5 x 10^7 total nucleated cells/Kg recipient body weight (pre-thaw).
Patients will have a back-up graft from any of the following: an available fraction of autologous marrow; or peripheral blood progenitor cells (PBPCs) harvested and cryopreserved; or family member donor; or a third cord blood unit.
Patients with any hematologic malignancy undergoing either an unmodified allogeneic HCT or a double umbilical cord blood transplant with or without the infusion of T-cell depleted HLA-haploidentical peripheral blood stem cells
Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)
Previous allogenic bone marrow transplant or double umbilical cord blood transplantation
UCB graft selected according to current University of Minnesota umbilical cord blood graft selection algorithm
No prior allogeneic bone marrow transplant or double umbilical cord blood transplantation (dUBCT)
DONOR: Peripheral blood is preferred over bone marrow for non-umbilical cord blood recipients
DONOR: Umbilical cord blood units will be selected according to the following umbilical cord blood graft selection criteria; one or 2 cord blood (CB) units may be used to achieve the required cell dose
PART 2: Patients without an HLA-identical or 1-allele-mismatched related donor or unrelated donor or umbilical cord blood units that meet transplant criteria
Subjects must have a back-up umbilical cord on the registry in addition to the umbilical cord being used in this study
DONOR (FHCRC only): Up to 5% of the unmanipulated cord blood product (s), when ready for infusion, may be withheld for research purposes as long as thresholds for infused TNC dose are met; these products will be used to conduct studies involving the kinetics of engraftment and immunobiology of double cord transplantation
DONOR: Any cord blood units with < 1.5 x 10^7 total nucleated cells per kilogram recipient weight
DONOR: Any cord blood units without full maternal testing and negative results for hepatitis A, B, C, HIV, and human T-lymphotropic virus (HTLV)-1 viruses; any additional available virology results on the unit itself will be reviewed but are not mandated, complete or always available; cord blood units are presumed to be CMV negative regardless of serologic testing due to passive transmission of maternal CMV antibodies
Patients who have received < 2 cycles of multiagent chemotherapy and patients who have received no multiagent chemotherapy within the 3 months previous to umbilical cord blood transplant (UCBT) as well as patients experiencing graft failure following previous allogeneic transplant
DONOR: Any cord blood units with < 1.5 x 10^7 total nucleated cells per kilogram recipient weight
DONOR: HPC-cord blood (CB) units will be obtained from established cord blood banks including, but not limited to: the National Marrow Donor Program, New York National Cord Blood Program, St. Louis Cardinal Glennon Cord Blood Bank, and University of Colorado Cord Blood Bank; umbilical cord blood unit (UCB) grafts will meet criteria established in Children’s Memorial Hospital Stem Cell Transplant Program policy VII-B entitled Allogeneic Donor Identification, Evaluation, Education, Consent and Management
Umbilical cord blood used as an unrelated stem cell source will provide > 2.0 x 10^7 cells/kg and will be matched at 4 - 6 of 6 HLA A, B, and DRBI loci; cord blood grafts may include a single or pair of cord units depending on the cell dose
Highly-matched unrelated umbilical cord blood (UCB) (> 7/8 matches identified by high-resolution typing) accepted if a sibling donor is not able to donate bone marrow AND UCB with a sufficient number of nucleated cells (NCs) (i.e., > 1.5 x 10^7/kg recipient body weight [BW]) is cryopreserved
Suitable UCB units available according to Umbilical Cord Blood Graft selection algorithm; the UCB graft may consist of one or two UCB units
Patients who have received Y-90 ibritumomab (zevalin) or I-131 tostumomab (bexxar), as part of their salvage therapy are not eligible for myeloablative umbilical cord blood transplant
UCB units will be selected according to current University of Minnesota umbilical cord blood graft selection algorithm; one or 2 UCB units may be used to achieve the required cell dose
Previous allogenic bone marrow transplant or cord blood transplantation.
Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)
PBSCs from identical twins are permitted, but no other allogeneic cells are allowed; sse of autologous stored umbilical cord blood stem cells is not allowed
Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
Previous allogeneic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)
Evidence suggestive of myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) on peripheral blood smear or bone marrow biopsy, if clinically indicated\r\n* No prior allogeneic bone marrow transplant or double umbilical cord blood transplantation (dUBCT)
Patients who have a 5/6 or better matched related donor or a 4/6 or better umbilical cord blood donor and who are medically eligible for conventional myeloablative or nonmyeloablative transplant will be excluded
Receiving umbilical cord blood
Cord blood transplant
Acute GVHD developing after allogeneic hematopoietic cell transplantation using either bone marrow, peripheral blood, or umbilical cord blood. Recipients of non-myeloablative, reduced intensity conditioning and myeloablative transplants are eligible. All allogeneic donor sources are permitted, including siblings, unrelated donors, human leukocyte antigen (HLA)-haploidentical related donors and umbilical cord blood.
No prior allogenic bone marrow transplant or double umbilical cord blood transplantation
Patients receiving bone marrow or umbilical cord blood as a stem cell source may also be considered for enrollment with acknowledgement that if there is insufficient product available for DLI, the patient will receive azacitidine without DLI per standard-risk treatment
A back-up graft identified, in case of graft failure, from any of the following sources: an available fraction of autologous marrow; or peripheral blood progenitor cells (PBPCs) harvested and cryopreserved; or family member donor; or a third cord blood unit
Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
Prior recipient of cord blood
Availability of suitable primary and secondary umbilical cord blood (UCB) units.
Has an available HCT donor or identified cord blood unit. Related and unrelated donors, and bone marrow, peripheral blood, or cord blood stem cell sources allowed
Umbilical cord HCT
Eligible patients will have one or more of the following donor stem cell sources:\r\n* Bone marrow\r\n* Placental blood (umbilical cord blood)\r\n* Cytokine mobilized peripheral blood
Any patient who has undergone a single or double umbilical cord blood transplant (UCBT) except those with primary myelofibrosis
All graft sources will be eligible (bone marrow, peripheral blood or umbilical cord blood)
Three umbilical cord blood (UCB) units composing the graft will be selected according to the current University of Minnesota umbilical cord blood graft selection algorithm
Allogeneic stem cell transplantation using a single or multiple umbilical cord blood units or using bone marrow
Have received first peripheral blood, marrow or cord blood transplant from a family or unrelated donor for hematologic malignancy or myeloproliferative disorder
UCB unit(s) composing the graft will be selected according to the current University of Minnesota umbilical cord blood graft selection algorithm plus an additional cord blood unit to be used as the source to manufacture the Treg product; this UCB unit must be matched at 4-6/6 to the patient, considering HLA-A, B at the antigen level and DRB1 at the allele level
Prior allogeneic bone marrow transplant or double umbilical cord blood transplantation
Receiving first allogeneic HSCT (bone marrow, peripheral blood stem cell, or cord blood transplant)
Unrelated donor, umbilical cord blood, mismatched, or haploidentical transplants