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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | N/A and Over |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT01028716 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Fred Hutchinson Cancer Research Center |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Rachel B. Salit |
Principal Investigator Affiliation | Fred Hutch/University of Washington Cancer Consortium |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Recruiting |
Countries | United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Acute Biphenotypic Leukemia, Acute Erythroid Leukemia in Remission, Acute Leukemia in Remission, Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Acute Myeloid Leukemia in Remission, Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With Inv(3) (q21.3;q26.2); GATA2, MECOM, Acute Myeloid Leukemia With Multilineage Dysplasia, Acute Myeloid Leukemia With t(6;9) (p23;q34.1); DEK-NUP214, 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), B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, Burkitt Lymphoma, Childhood Acute Lymphoblastic Leukemia in Complete Remission, DS Stage II Plasma Cell Myeloma, DS Stage III Plasma Cell Myeloma, Myelodysplastic Syndrome, Recurrent Anaplastic Large Cell Lymphoma, Blasts Under 5 Percent of Bone Marrow Nucleated Cells, 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, T Lymphoblastic Lymphoma, Hematopoietic Cell Transplant Recipient |
PRIMARY OBJECTIVES:
Experimental: Treatment (nonmyeloablative HCT, TBI)
Patients receive fludarabine 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 PO BID on days 5-180 (may be continued if active GvHD is present), mycophenolate mofetil IV or PO TID on days 5-35 (may be continued if GvHD present), and filgrastim IV beginning on day 5 until the ANC is >= 1,000/mm^3 for three consecutive days.
Drug: - Cyclophosphamide
Given IV
Biological: - Filgrastim
Given IV
Drug: - Fludarabine Phosphate
Given IV
Procedure: - Laboratory Biomarker Analysis
Correlative studies
Drug: - Mycophenolate Mofetil
Given PO
Procedure: - Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Undergo PBSC
Procedure: - Peripheral Blood Stem Cell Transplantation
Undergo PBSC
Drug: - Tacrolimus
Given IV or PO
Radiation: - Total-Body Irradiation
Undergo total-body irradiation (TBI)
Drug: - Fludarabine
Given IV
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Withdrawn
Address
VA Puget Sound Health Care System
Seattle, Washington, 98101
Status
Recruiting
Address
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109