Engineered Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Lymphoblastic Leukemia
- Acute Myeloid Leukemia
- Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
- Aplastic Anemia
- Recurrent Plasma Cell Myeloma
- Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Chronic Myelomonocytic Leukemia
- Recurrent Non-Hodgkin Lymphoma
- Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Lymphoblastic Lymphoma
- Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- Myelodysplastic Syndrome
- Recurrent Hodgkin Lymphoma
- Myeloproliferative Neoplasm
- Plasma Cell Myeloma
- Therapy-Related Myelodysplastic Syndrome
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: I. To assess the safety of a modified peripheral blood (PB) graft for haploidentical transplantation, obtained by using depletion of naive, cluster of differentiation (CD)45RA+ T cells. SECONDARY OBJECTIVES: I. To estimate the proportion of patients with engraftment/graft failure....
PRIMARY OBJECTIVE: I. To assess the safety of a modified peripheral blood (PB) graft for haploidentical transplantation, obtained by using depletion of naive, cluster of differentiation (CD)45RA+ T cells. SECONDARY OBJECTIVES: I. To estimate the proportion of patients with engraftment/graft failure. II. To determine the day 100 and 6 month non-relapse mortality (NRM). III. To estimate the cumulative incidence of grade 2-4 and 3-4 acute graft versus (vs.) host disease (aGVHD). IV. To assess the rate of chronic GVHD within the first year post transplantation. V. To assess immune reconstitution and the incidence of infectious episodes. VI. To assess disease response, disease-free survival (DFS) and overall survival (OS) after transplantation. VII. To compare results with a retrospective cohort of patients treated with bone marrow graft on protocol 2009-0266. OUTLINE: Patients receive melphalan intravenously (IV) over 30 minutes on day -6 and fludarabine phosphate IV over 1 hour on days -6 to -3. Patients undergo total-body irradiation (TBI) on day -2 and CD45RA depleted peripheral blood stem cell transplantation on day 0. Patients also receive cyclophosphamide IV over 3 hours on days 3-4. Beginning on day 5, patients receive tacrolimus IV for 2 weeks and orally (PO) for at least 4 months. Beginning on day 7, patients receive filgrastim subcutaneously (SC) daily. Patients with CD20 positive lymphoma may receive rituximab IV on days -13, -6, 1, and 8. After completion of study treatment, patients are followed up periodically.
Tracking Information
- NCT #
- NCT02960646
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Samer Srour M.D. Anderson Cancer Center