Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
Last updated on July 2021Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 81
Summary
- Conditions
- Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
- Accelerated Phase Chronic Myelogenous Leukemia
- Adult Acute Lymphoblastic Leukemia in Remission
- Adult Acute Myeloid Leukemia in Remission
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Childhood Chronic Myelogenous Leukemia
- Hepatosplenic T Cell Lymphoma
- Recurrent Grade 2 Follicular Lymphoma
- Recurrent Mantle Cell Lymphoma
- Recurrent Adult Hodgkin Lymphoma
- Childhood Acute Myeloid Leukemia in Remission
- Secondary Myelofibrosis
- Chronic Myelomonocytic Leukemia
- Adult Acute Myeloid Leukemia With Del(5q)
- Recurrent/Refractory Childhood Hodgkin Lymphoma
- Shwachman-Diamond Syndrome
- Childhood Acute Lymphoblastic Leukemia in Remission
- Childhood Grade III Lymphomatoid Granulomatosis
- Recurrent Adult Acute Myeloid Leukemia
- Recurrent Marginal Zone Lymphoma
- Recurrent Adult Burkitt Lymphoma
- Recurrent Childhood Large Cell Lymphoma
- Severe Combined Immunodeficiency
- Refractory Chronic Lymphocytic Leukemia
- Paroxysmal Nocturnal Hemoglobinuria
- Recurrent Childhood Acute Myeloid Leukemia
- Recurrent Adult T-cell Leukemia/Lymphoma
- Recurrent Small Lymphocytic Lymphoma
- Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
- Childhood Diffuse Large Cell Lymphoma
- Recurrent Childhood Grade III Lymphomatoid Granulomatosis
- Recurrent Adult Diffuse Large Cell Lymphoma
- Childhood Immunoblastic Large Cell Lymphoma
- Childhood Nasal Type Extranodal NK/T-cell Lymphoma
- Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
- Anaplastic Large Cell Lymphoma
- Recurrent Childhood Anaplastic Large Cell Lymphoma
- Peripheral T Cell Lymphoma
- Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
- Angioimmunoblastic T Cell Lymphoma
- Primary Myelofibrosis
- Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
- Nodal Marginal Zone B-cell Lymphoma
- Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
- Burkitt Lymphoma
- Recurrent Adult Lymphoblastic Lymphoma
- Wiskott- Aldrich Syndrome
- Recurrent Childhood Small Noncleaved Cell Lymphoma
- Waldenstrom Macroglobulinemia
- Congenital Amegakaryocytic Thrombocytopenia
- T-cell Large Granular Lymphocyte Leukemia
- Recurrent Mycosis Fungoides/Sezary Syndrome
- Splenic Marginal Zone Lymphoma
- Aplastic Anemia
- Recurrent Adult Acute Lymphoblastic Leukemia
- Recurrent Grade 1 Follicular Lymphoma
- Secondary Acute Myeloid Leukemia
- Polycythemia Vera
- Recurrent Adult Immunoblastic Large Cell Lymphoma
- Childhood Myelodysplastic Syndromes
- Recurrent Grade 3 Follicular Lymphoma
- Chronic Phase Chronic Myelogenous Leukemia
- Adult Grade III Lymphomatoid Granulomatosis
- Recurrent Childhood Lymphoblastic Lymphoma
- Juvenile Myelomonocytic Leukemia
- Severe Congenital Neutropenia
- Refractory Hairy Cell Leukemia
- Secondary Myelodysplastic Syndromes
- Refractory Multiple Myeloma
- Diamond Blackfan Anemia
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
- Previously Treated Myelodysplastic Syndromes
- Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
- Recurrent Childhood Acute Lymphoblastic Leukemia
- Recurrent Adult Diffuse Mixed Cell Lymphoma
- Post Transplant Lymphoproliferative Disorder
- Adult Nasal Type Extranodal NK/T-cell Lymphoma
- Recurrent Adult Grade III Lymphomatoid Granulomatosis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 3 years and 75 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To determine the transplant related mortality (TRM) of this reduced-intensity transplantation (RIT) combination, fludarabine (fludarabine phosphate), melphalan, and TBI in a patient population usually not eligible for a full a myeloablative allogeneic hematopoietic stem cell t...
PRIMARY OBJECTIVES: I. To determine the transplant related mortality (TRM) of this reduced-intensity transplantation (RIT) combination, fludarabine (fludarabine phosphate), melphalan, and TBI in a patient population usually not eligible for a full a myeloablative allogeneic hematopoietic stem cell transplantation (HSCT). SECONDARY OBJECTIVES: I. To evaluate clinical response, progression free survival (PFS) at one year, engraftment rate, and graft-versus-host disease (GvHD) incidence with the proposed RIT regimen across a variety of hematological conditions. II. Correlative studies will include chimerism analysis by molecular analysis and evaluation of immune reconstitution by cytomegalovirus (CMV) dextramer analysis using flow cytometry. OUTLINE: PREPARATIVE REGIMEN: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI twice daily (BID) on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or orally (PO) BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15-30 minutes on days 1, 3, and 6. After completion of study treatment, patients are followed up periodically.
Tracking Information
- NCT #
- NCT01529827
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: George Chen Roswell Park Cancer Institute
Get Well Soon