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

Myelodysplastic Syndrome Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Acute Biphenotypic Leukemia
• Acute Erythroid Leukemia in Remission
• Acute Leukemia in Remission
• Acute Lymphoblastic Leukemia in Remission
• Acute Myeloid Leukemia in Remission
• Acute Myeloid Leukemia With FLT3/ITD Mutation
• Acute Myeloid Leukemia With Multilineage Dysplasia
• Acute Undifferentiated Leukemia
• Adult Acute Lymphoblastic Leukemia in Complete Remission
• B Acute Lymphoblastic Leukemia With T(1;19)(Q23;P13.3); E2A-PBX1 (TCF3-PBX1)
• Blasts Under 5 Percent of Bone Marrow Nucleated Cells
• Burkitt Lymphoma
• Childhood Acute Lymphoblastic Leukemia in Complete Remission
• DS Stage II Plasma Cell Myeloma
• DS Stage III Plasma Cell Myeloma
• Hematologic Neoplasms
• Hematopoietic Cell Transplant Recipient
• Leukemia
• Leukemia, Biphenotypic, Acute
• Leukemia, Erythroblastic, Acute
• Leukemia, Lymphoid
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Lymphoma
• Lymphoma, Large-Cell, Anaplastic
• Lymphoma, Mantle-Cell
• Multiple Myeloma
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Neoplasms, Plasma Cell
• Ph+ ALL
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Preleukemia
• Recurrence
• Recurrent Anaplastic Large Cell Lymphoma
• Recurrent Follicular Lymphoma
• Recurrent Hodgkin Lymphoma
• Recurrent Mantle Cell Lymphoma
• Recurrent Marginal Zone Lymphoma
• Recurrent Plasma Cell Myeloma
• Refractory Plasma Cell Myeloma
• Secondary Acute Myeloid Leukemia
• Syndrome
• T Lymphoblastic Lymphoma

• NCT number: NCT01028716
• Study type: Interventional
• Source: Fred Hutchinson Cancer Center
• Status: Terminated
• Phase: Phase 2
• Start date: May 19, 2010
• Completion date: October 7, 2021