TerminatedPhase 2

Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies

Stopped: The study experienced lower accrual rates after the onset of COVID. Upon review of the collected data it was deemed that an adequate amount of subjects has been enrolled to date to assess study aims.

United States46 participantsStarted 2010-05-19

Plain-language summary

This phase II trial studies how well donor peripheral blood stem cell (PBSC) transplant works in treating patients with hematologic malignancies. Cyclophosphamide when added to tacrolimus and mycophenolate mofetil is safe and effective in preventing severe graft-versus-host disease (GVHD) in most patients with hematologic malignancies undergoing transplantation of bone marrow from half-matched (haploidentical) donors. This approach has extended the transplant option to patients who do not have matched related or unrelated donors, especially for patients from ethnic minority groups. The graft contains cells of the donor's immune system which potentially can recognize and destroy the patient's cancer cells (graft-versus-tumor effect). Rejection of the donor's cells by the patient's own immune system is prevented by giving low doses of chemotherapy (fludarabine phosphate and cyclophosphamide) and total-body irradiation before transplant. Patients can experience low blood cell counts after transplant. Using stem cells and immune cells collected from the donor's circulating blood may result in quicker recovery of blood counts and may be more effective in treating the patient's disease than using bone marrow.

Who can participate

SexALL

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Inclusion Criteria: * Molecular based human leukocyte antigen (HLA) typing will be performed for the HLA-A, -B, -Cw, -DRB1 and -DQB1 loci to the resolution adequate to establish haplo-identity; a minimum match of 5/10 is required; an unrelated donor search is not required for a patient to be eligible for this protocol if the clinical situation dictates an urgent transplant; clinical urgency is defined as 6-8 weeks from referral or low-likelihood of finding a matched, unrelated donor * Acute leukemias (includes T lymphoblastic lymphoma); remission is defined as \< 5% blasts with no morphological characteristics of acute leukemia (e.g., Auer rods) in a bone marrow with \> 20% cellularity, peripheral blood counts showing ANC \> 1000/ul, including patients in complete remission with incomplete platelet recovery (CRp); if the marrow has \< 20% cellularity due to treatment related cytotoxicity, but still has \< 5% blasts, an exception may be made to include this patient up to principal investigator (PI) discretion * Acute lymphoblastic leukemia in high risk first complete remission (CR1) as defined by at least one of the following: * Adverse cytogenetics including but not limited to t(9;22), t(1;19), t(4;11), mixed lineage leukemia (MLL) rearrangements * White blood cell counts \> 30,000/mcL * Patients over 30 years of age * Time to complete remission \> 4 weeks * Presence of extramedullary disease * Minimal residual disease * Other risk factors determined by the pa…

What they're measuring

Non-relapse Mortality at 1 Year

Timeframe: Up to 1 year

Percentage of Participants With Chronic Graft Versus Host Disease

Timeframe: Up to 2 years post-transplant

Incidence of Grades III/IV Acute Graft Versus Host Disease

Timeframe: At day 84

Relapse of Malignancy After Transplantation

Timeframe: Up to 7 years

Trial details

NCT IDNCT01028716

SponsorFred Hutchinson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-07

Results submitted2022-10-06

View on ClinicalTrials.gov More Acute Biphenotypic Leukemia trials