Double Cord Versus Haploidentical (Blood and Marrow Transplant Clinical Trials Network #1101)
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: III What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 12-007946
NCT ID: NCT01597778
Sponsor Protocol Number: BMT CTN 1101
About this study
Hematopoietic cell transplants (HCT) are one treatment option for people with leukemia or lymphoma. Family members, unrelated donors or banked umbilical cordblood units with similar tissue type can be used for HCT. This study will compare the effectiveness of two new types of bone marrow transplants in people with leukemia or lymphoma: one that uses bone marrow donated from family members with only partially matched bone marrow; and, one that uses two partially matched cord blood units.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
- Patients 18 to 70 years old
- Patients must have available both:
- One or more potential related mismatched donors (biologic parent(s) or siblings (full or half) or children). At least low resolution DNA based HLA typing at HLA-A, -B, and -DRB1 for potential haploidentical sibling donors is required.
- At least two potential umbilical cord blood units identified.
- 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). Confirmatory typing is not required for randomization.
- 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 (B-ALL) or greater than 100,000/mcL (T-ALL)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. Favorable risk is defined as having one of the following:
- t(8.21) without CKIT mutation,
- inv(16) without CKIT mutation or t(16;16),
- normal karyotype with mutated NPM1 and not FLT-IND, normal karyotype with double mutated CEBPA,
- APL in first molecular remission at end of consolidation
- Acute Leukemias in 2nd or subsequent CR
- Biphenotypic/Undifferentiated/Prolymphocyctic Leukemias in first or subsequent CR, adult T-cell leukemia/lymphoma in first or subsequent CR
- Burkitt's lymphoma: second or subsequent CR
- Lymphoma fulfilling the following criteria: a) Chemotherapy-sensitive (complete or partial response; 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).
- Performance status: Karnofsky score greater than or equal to 70%.
Additional Patient Inclusion Criteria for Conditioning:
- Patients with Adequate Physical Function as Measured by:
- Cardiac: Left ventricular ejection fraction at rest must be greater than or equal to 40%, or shortening fraction less than 25%;
- 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;
- 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^; d. Pulmonary: DLCO (corrected for hemoglobin), FEV1, and FVC greater than 50% predicted;
- 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.
- Additional Patient Inclusion Criteria for Patients Assigned to Double Umbilical Cord Blood Arm:
- Patients must have available two UCB units fulfilling the following criteria:
- 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 x10^7/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).
- Additional graft selection criteria specified in section 2.5
- Patients must have received at least one cycle of the cytotoxic chemotherapy regimens (or regimen of similar intensity) listed in Appendix D within 3 months of enrollment (measured from the start date of chemotherapy) OR have had an autologous transplant within 24 months of enrollment OR receive 300 cGy as part of the preparative regimen
- Patients with suitably matched related or unrelated donor, as defined per institutional practice.
- Recipients of prior autologous hematopoietic stem cell transplantation are ineligible if disease recurrence occurred less than 6 months from their autologous stem cell transplant.
- 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.
Additional exclusion criteria:
- Pregnancy or breast-feeding.
- Evidence of HIV infection or known HIV positive serology.
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Shahrukh Hashmi, M.D.
Closed for enrollment
Cancer Center Clinical Trials Referral Office