A 2 Step Approach to Haploidentical Transplant Using Radiation-Based Reduced Intensity Conditioning
Thomas Jefferson University
Summary
This phase II clinical trial evaluates whether a modified modality of conditioning reduces treatment-related mortality (TRM) in patients who undergo a hematopoietic stem cell transplant (HSCT) for a hematological malignancy. HSCT is a curative therapy for many hematopoietic malignancies, however this regimen results in higher rates of TRM than other forms of treatment. In recent years, less intense conditioning regimens with radiation and chemotherapy prior to HSCT have been developed. Radiation therapy uses high energy sources to kill cancer cells and shrink tumors while chemotherapy drugs like fludarabine and cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This study evaluates whether a two-step approach with lower-intensity regimens of these treatments prior to HSCT reduces the rate of TRM.
Description
PRIMARY OBJECTIVE: I. To assess the 2 year cumulative incidence of TRM in patients undergoing reduced intensity conditioning (RIC) haploidentical (HI) HSCT in this protocol. SECONDARY OBJECTIVES: I. To assess the 2 year cumulative incidence of relapse in patients undergoing RIC HI HSCT in this protocol. II. To assess the consistency and pace of engraftment. III. To assess the pace of T cell and B cell immune recovery. IV. To assess the incidence and severity of graft versus host disease (GVHD). OUTLINE: Patients are assigned to 1 of 2 cohorts. RADIATION-BASED COHORT: Patients receive flu…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Radiation-based cohort diagnoses: * Acute myeloid leukemia * Acute lymphoid leukemia in remission * Myelodysplasia (MDS) * Chronic lymphocytic leukemia (CLL) with no or minimal lymph node involvement * Multiple myeloma * Chronic myeloid leukemia * Myelofibrosis * Myeloid malignancy not otherwise specified * Chronic myelomonocytic leukemia * Essential thrombocytopenia or polycythemia vera * T cell leukemia * T cell lymphoma without significant lymph node disease burden * Any hematological malignancy or dyscrasia not cited above in which HSCT is…
Interventions
- DrugFludarabine
Given IV
- RadiationTotal-Body Irradiation
Undergo TBI
- ProcedureDonor Lymphocyte Infusion
Undergo DLI
- DrugCyclophosphamide
Given IV
- DrugTacrolimus
Given IV
- DrugMycophenolate Mofetil
Given IV
- ProcedureHematopoietic Cell Transplantation
Undergo HSCT
Location
- Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhiladephia, Pennsylvania