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Complete title: A Multi-Center, Phase III, Randomized Trial of Reduced Intensity (RIC) Conditioning and Transplantation of Double Unrelated Umbilical Cord Blood (dUCB) versus HLA-Haploidentical Related Bone Marrow for Patients with Hematologic Malignancies
|Research Study Number||2580.00|
|Principal Investigator||Paul O'Donnell, MD, PhD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
- Genders Eligible for Study: Both
- Patients 18 to 70 years old
- 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 both: a)A related haploidentical BM donor with 2, 3, or 4 HLA-mismatches. The donor and recipient must be HLA identical for at least one allele of the following genetic loci: HLA-A, HLA-B, HLA-C, and HLA-DRB1. b)two UCB units. Each unit must have a minimum of 1.5 x 10^7/kg pre-cryopreserved total nucleated cell dose. For non-red blood cell depleted units, the minimum pre-cryopreserved total nucleated cell dose of each unit must be at least 2.0 x 10^7/kg. Units must be HLA matched at a minimum of 4/6 to the recipient at HLA-A, HLA-B (at low resolution using DNA based typing) and HLA-DRB1 (at high resolution using DNA based typing). Units must be HLA matched at a minimum of 4/6 to each other at HLA-A, HLA-B (at low resolution using DNA based typing) and HLA-DRB1 (at high resolution using DNA based typing), but not necessarily at the same HLA-loci as with the recipient.
- Patients must have received either: a) At least one cycle of a cytotoxic chemotherapy regimen or, b) Autologous HCT greater than 6 months and less than 2 years prior to enrollment.
- ALL in first complete remission (CR1) that is NOT considered favorable-risk as defined by the presence of at least one of the following: Adverse cytogenetics such as t(9;22), t(1;19), t(4;11), other MLL rearrangements; White blood cell counts of greater than 30,000/mcL at diagnosis; Recipient age older than 30 years at diagnosis; Time to CR greater than 4 weeks
- AML in CR1 that is NOT considered as favorable-risk as defined by the presence of at least one of the following: Greater than 1 cycle of induction therapy required to achieve remission; Preceding myelodysplastic syndrome (MDS); Treatment-related AML; Presence of Flt3 abnormalities; FAB M6 or M7 leukemia; or, Adverse cytogenetics for overall survival
- Acute Leukemias in 2nd or subsequent CR
- Biphenotypic/Undifferentiated Leukemias in first or subsequent CR
- Burkitt's lymphoma: second or subsequent CR
- Lymphoma fulfilling the following criteria: a) Chemotherapy-sensitive (complete or partial response; large cell, Mantle cell or Hodgkin lymphomas that have failed at least 1 prior regimen of multi-agent chemotherapy and are INELIGIBLE for an autologous transplant; b) Marginal zone B-cell lymphoma or follicular lymphoma that has progressed after at least at least two prior therapies (excluding single agent Rituxan).
- Patients with adequate physical function as measured by:
1) Cardiac: Left ventricular ejection fraction at rest must be greater than or equal to 40%, or shortening fraction greater than 25%.
2) Hepatic: Bilirubin less than or equal to 2.5 mg/dL, except for patients with Gilbert's syndrome or hemolysis; ALT, AST, and Alkaline Phosphatase less than 5 x ULN.
3) Renal: Serum creatinine within normal range, or if serum creatinine outside normal range, then renal function (measured or estimated creatinine clearance or GFR) greater than 40 mL/min/1.73m^2.
4) Pulmonary: DLCO (corrected for hemoglobin), FEV1, and FVC greater than 50% predicted.
- Karnofsky score greater than or equal to 70%.
- Donors must be HLA-haploidentical first-degree relatives of the patient. Eligible donors include biological parents, siblings or half siblings, or children.
- For donors less than 18 years old, the maximum recipient weight (kg IBW) should not exceed 1.25 times the donor weight (kg IBW)
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Autologous hematopoietic stem cell transplant less than 6 months prior to enrollment.
- Pregnancy or breast-feeding.
- Evidence of HIV infection or known HIV positive serology.
- Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings).
- Prior allogeneic HCT.
- Patients with history of primary idiopathic myelofibrosis or any severe marrow fibrosis.
- Planned use of prophylactic donor lymphocyte infusion (DLI) therapy.
- Anti-donor HLA antibodies.
Other exclusion criteria may apply.
Burkitt's Lymphoma; Hematologic Malignancies; Hodgkin's Lymphoma; Leukemia; Lymphoma; Non-Hodgkin's Lymphoma (NHL)
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