Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Blood Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Myeloid Leukemia With FLT3/ITD Mutation
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Immunodeficiency Syndrome
- Secondary Myelodysplastic Syndrome
- Acute Leukemia in Remission
- Acute Lymphoblastic Leukemia
- Congenital Neutropenia
- Secondary Acute Myeloid Leukemia
- Chronic Lymphocytic Leukemia
- Shwachman-Diamond Syndrome
- Wiskott- Aldrich Syndrome
- Glanzmann Thrombasthenia
- Plasma Cell Myeloma
- Refractory Non Hodgkin Lymphoma
- Myeloproliferative Neoplasm
- Myelofibrosis
- Acute Myeloid Leukemia
- Acute Myeloid Leukemia With Gene Mutations
- Myelodysplastic Syndrome
- Aplastic Anemia
- B-cell Non Hodgkin Lymphoma
- CD40 Ligand Deficiency
- Recurrent Non-Hodgkin Lymphoma
- Chronic Granulomatous Disease
- Congenital Amegakaryocytic Thrombocytopenia
- Chronic Myelomonocytic Leukemia
- Paroxysmal Nocturnal Hemoglobinuria
- T Cell Non-Hodgkin Lymphoma
- Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Chronic Leukemia in Remission
- Congenital Pure Red Cell Aplasia
- ? Thalassemia
- Severe Aplastic Anemia
- Waldenstrom Macroglobulinemia
- Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Polycythemia Vera
- Sickle Cell Disease
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 1 years and 75 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To evaluate the rate of relapse, defined as recurrence of underlying disease or progression of underlying disease, at 1 year in patients who receive haploidentical peripheral blood stem cells (PBSCs) after reduced intensity conditioning and post-transplant cyclophosphamide. SE...
PRIMARY OBJECTIVES: I. To evaluate the rate of relapse, defined as recurrence of underlying disease or progression of underlying disease, at 1 year in patients who receive haploidentical peripheral blood stem cells (PBSCs) after reduced intensity conditioning and post-transplant cyclophosphamide. SECONDARY OBJECTIVES: I. To evaluate safety including development of acute graft versus host disease (GVHD) and death at 100 days post-transplant, as well as other treatment related toxicities including chronic GVHD, engraftment rate, non-relapse mortality, progression free survival (PFS) at one year, and overall survival (OS) at one year, as compared with historical controls. TERTIARY OBJECTIVES: I. Correlative studies will include chimerism analysis by molecular analysis and evaluation of immune reconstitution by cytomegalovirus (CMV) dextramer analysis using flow cytometry. OUTLINE: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients undergo total body irradiation (TBI) on days -1 and peripheral blood stem cell transplantation (PBSCT) on day 0. After completion of study treatment, patients are followed up at 30 and 100 days.
Tracking Information
- NCT #
- NCT03333486
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Sophia Balderman Roswell Park Cancer Institute
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