Clinical Trials Directory

Trials / Terminated

TerminatedNCT01028716

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

Nonmyeloablative Hematopoietic Cell Transplantation (HCT) for Patients With Hematologic Malignancies Using Related, HLA-Haploidentical Donors: A Phase II Trial of Peripheral Blood Stem Cells (PBSC) as the Donor Source

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
46 (actual)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
—
Healthy volunteers
Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To demonstrate that use of PBSC in place of marrow as the source of lymphocytes and stem cells for nonmyeloablative transplants from related, haploidentical donors will not result in unacceptable rates of high-grade acute or chronic GVHD, non-relapse mortality or relapse compared to historical data on nonmyeloablative transplants from unrelated donors. SECONDARY OBJECTIVES: I. Estimates of the rates of neutrophil and platelet recovery, number of red blood cell (RBC) and platelet transfusions, incidences of graft failure, transplant-related toxicities, disease-free survival and overall survival. OUTLINE: Patients receive fludarabine intravenously (IV) over 30-60 minutes daily on days -6 through -2 and cyclophosphamide IV over 1-2 hours on days -6, -5, and 3-4. Patients undergo total-body irradiation on day -1. Patients undergo donor peripheral blood stem cell transplant on day 0. Patients then receive tacrolimus IV once daily or orally (PO) twice daily (BID) on days 5-180 (may be continued if active GVHD is present), mycophenolate mofetil IV or PO thrice daily (TID) on days 5-35 (may be continued if GVHD present), and filgrastim IV beginning on day 5 until the absolute neutrophil count (ANC) is \>= 1,000/mm\^3 for three consecutive days. Treatment continues in the absence of disease progression or unacceptable toxicity.

Conditions

Interventions

TypeNameDescription
DRUGCyclophosphamideGiven IV
BIOLOGICALFilgrastimGiven SQ
DRUGFludarabine PhosphateGiven IV
DRUGMycophenolate MofetilGiven PO
PROCEDURENonmyeloablative Allogeneic Hematopoietic Stem Cell TransplantationUndergo PBSC
PROCEDUREPeripheral Blood Stem Cell TransplantationUndergo PBSC
DRUGTacrolimusGiven IV or PO
RADIATIONTotal-Body IrradiationUndergo total-body irradiation (TBI)

Timeline

Start date
2010-05-19
Primary completion
2021-10-07
Completion
2021-10-07
First posted
2009-12-09
Last updated
2023-01-23
Results posted
2023-01-23

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT01028716. Inclusion in this directory is not an endorsement.