At a glance
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Non-Myeloablative Chemotherapy Followed by HLA-Matched Related Allogeneic Stem Cell Transplantation for Hematologic Malignancies
In Brief
A clinical study evaluating Stem Cell Transplant, G-CSF, and 4 other interventions for Hematologic Malignancies. Completed, enrolled 18 participants across 1 site.
Detailed Summary
The purpose of this study is to determine disease-free survival, overall survival, time to progression, regimen-related toxicity and/or treatment-related mortality in patients with hematologic malignancies treated with non-myeloablative chemotherapy followed by allogeneic stem cell transplant.
Study Details
Timeline
Interventions
Donor: Prior to mobilization, leukapheresis to collect CD3+ cells. The donor will then receive G-CSF (10 mcg/kg/day) with leukapheresis collection of peripheral blood stem cells on days 5, 6 and 7 as needed. Goal of leukapheresis will be \> 5 x 106 CD34+cells/kg of recipient. Patient: Peripheral Blood Stem Cell (PBSC) Transplant. Fludarabine 25mg/m2/d IV over 30 minutes on days -6 to -2, followed by cyclophosphamide 1g/m2/d IV on days -3 and -2. This will be followed by allogeneic stem cell infusion 48 hours later. Donor Lymphocyte Infusion (DLI) and Adjustment of Immunosuppression: Cyclosporine (CSA) and methotrexate (MTX) will be used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml.
10 mcg/kg/day on days 5, 6, and 7
25 mg/m2/d IV over 30 minutes on days -6 to -2
1 g/m2/d IV on days -3 and -2
used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml
used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml