Reduced Intensity Chemotherapy and Radiation Therapy Before 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 Myeloid Leukemia
- Acute Myeloid Leukemia in Remission
- Aplastic Anemia
- Chronic Myelomonocytic Leukemia
- Hodgkin Lymphoma
- Indolent Non Hodgkin Lymphoma
- Malignant Neoplasm
- Refractory Cytopenia With Multilineage Dysplasia and Ring Sideroblasts
- Myelodysplastic Syndrome
- Myeloproliferative Neoplasm
- Refractory Anemia With Excess Blasts
- Refractory Cytopenia With Multilineage Dysplasia
- Plasma Cell Myeloma
- Refractory Anemia
- Refractory Anemia With Ring Sideroblasts
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To demonstrate efficacy of this approach over the historical 2 step reduced intensity conditioning (RIC) approaches in the "vulnerable" population defined as: patients with hematopoietic cell transplant (HCT)-co-morbidity index (CI)/age scores >= 2, but no more than a score of...
PRIMARY OBJECTIVES: I. To demonstrate efficacy of this approach over the historical 2 step reduced intensity conditioning (RIC) approaches in the "vulnerable" population defined as: patients with hematopoietic cell transplant (HCT)-co-morbidity index (CI)/age scores >= 2, but no more than a score of 5 as based on the Sorror et al. data. SECONDARY OBJECTIVES: I. To compare the non-relapse mortality (NRM) and relapse related mortality (RRM) rates at 1 year for patients treated on this study to the that of patients undergoing haploidentical RIC hematopoietic stem cell transplantation (HSCT) as reported in the literature and as observed in the 2 step RIC trials. II. To determine the incidence and severity of graft-versus-host disease (GVHD) in patients undergoing treated on the Thomas Jefferson University (TJU) RIC 2 step approach. III. To evaluate engraftment rates and lymphoid reconstitution in patients treated on the TJU RIC 2 step approach. OUTLINE: RIC: Patients receive fludarabine phosphate intravenously (IV) over 60 minutes on days -10 to -8 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients also undergo total body irradiation (TBI) followed by a donor lymphocyte infusion (DLI) on day -6. TRANSPLANT: Patients undergo cluster of differentiation (CD)34+ peripheral blood stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus orally (PO) beginning day -1 with a taper initiated on day 42 and mycophenolate mofetil IV twice daily (BID) on days -1 to 28 in the absence of GVHD. After completion of study treatment, patients are followed up for 1 year.
Tracking Information
- NCT #
- NCT02566304
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Dolores Grosso, DNP, CRNP Thomas Jefferson University Principal Investigator: Neal Flomenberg, MD Thomas Jefferson University