Hematologic/Blood Cancers – NCI-09-C-0210
Dr. Michael R. Bishop
Principal Investigator
NCI’s Center for Cancer Research (CCR) is currently conducting the following trial for patients with hematologic malignancies. Click on the trial below for additional details, including a summary of primary eligibility, study outline, and information on how to contact Dr. Bishop, and his staff directly.
You may also call the Clinical Trials Referral Office at 1-888-NCI-1937 (1-888-624-1937) to inquire about referring a patient to this trial.
This is a pilot study of TID in the setting of reduced-intensity double cord blood transplant in adults.
- All patients will receive:
- Disease-specific induction chemotherapy (EPOCH-F/R or FLAG) prior to transplant for disease control and immune depletion
- A conditioning regimen consisting of cyclophosphamide 1,200 mg/m2/day IV for 4 days and fludarabine 30 mg/m2/day for 4 days
- GVHD prophylaxis regimen consisting of tacrolimus, starting day -3 before transplant, given initially at 0.02 mg/kg/day CIV and then an equivalent oral dose for 6 months, and sirolimus given as an initial loading dose of 12 mg p.o. on Day -3 pretransplant and subsequently 4 mg daily through 6 months post transplant
Why is this trial important?
Because only 25–30% of patients have an HLA-identical sibling donor, and many patients do not have an adequately HLA-matched unrelated donor, especially racial and ethnic minorities, the transplantation of umbilical cord blood (UCB) represents the most recent strategy to expand the potential donor pool. Umbilical cord blood transplantation permits a higher degree of HLA disparity while demonstrating a reduction in the incidence of graft versus host disease (GVHD) compared with unrelated donor and hapoidentical transplant modalities.
The major limitations of umbilical cord blood transplantation (UCBT) in adults are graft rejection and delayed engraftment leading to increased infection-related morbidity and treatment-related mortality (TRM). To increase engraftment rates while enhancing graft-versus- tumor effect, previous studies within our institution have employed the strategy of targeted immune depletion (TID). The TID approach attempts to compensate for variability in host immune status and facilitate engraftment by using repetitive cycles of disease-specific conventional-dose chemotherapy to provide both tumor control and lymphocyte depletion prior to transplant. Our aim in the current protocol is to extend the strategy of TID to reduced-intensity UCBT, with the goal of more rapid engraftment, leading to decreased TRM and increased overall survival. Our intention is to investigate this approach in the setting of double cord blood transplant in adults in a pilot manner.
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