Recruitment

Recruitment Status
Completed
Estimated Enrollment
81

Summary

Conditions
  • Adult Acute Myeloid Leukemia With Del(5q)
  • Accelerated Phase Chronic Myelogenous Leukemia
  • Adult Acute Lymphoblastic Leukemia in Remission
  • Adult Acute Myeloid Leukemia in Remission
  • Recurrent Mycosis Fungoides/Sezary Syndrome
  • Shwachman-Diamond Syndrome
  • Recurrent/Refractory Childhood Hodgkin Lymphoma
  • Hepatosplenic T Cell Lymphoma
  • Recurrent Adult Diffuse Mixed Cell Lymphoma
  • Recurrent Childhood Large Cell Lymphoma
  • Primary Myelofibrosis
  • Recurrent Adult Burkitt Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Hairy Cell Leukemia
  • Recurrent Adult Lymphoblastic Lymphoma
  • Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
  • Post Transplant Lymphoproliferative Disorder
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Chronic Myelomonocytic Leukemia
  • Childhood Nasal Type Extranodal NK/T-cell Lymphoma
  • Diamond Blackfan Anemia
  • Nodal Marginal Zone B-cell Lymphoma
  • Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
  • Recurrent Childhood Small Noncleaved Cell Lymphoma
  • T-cell Large Granular Lymphocyte Leukemia
  • Recurrent Small Lymphocytic Lymphoma
  • Juvenile Myelomonocytic Leukemia
  • Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
  • Polycythemia Vera
  • Recurrent Mantle Cell Lymphoma
  • Childhood Diffuse Large Cell Lymphoma
  • Chronic Phase Chronic Myelogenous Leukemia
  • Angioimmunoblastic T Cell Lymphoma
  • Burkitt Lymphoma
  • Recurrent Adult Grade III Lymphomatoid Granulomatosis
  • Recurrent Grade 1 Follicular Lymphoma
  • Secondary Acute Myeloid Leukemia
  • Recurrent Childhood Acute Myeloid Leukemia
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Childhood Anaplastic Large Cell Lymphoma
  • Recurrent Adult T-cell Leukemia/Lymphoma
  • Anaplastic Large Cell Lymphoma
  • Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
  • Childhood Chronic Myelogenous Leukemia
  • Paroxysmal Nocturnal Hemoglobinuria
  • Severe Congenital Neutropenia
  • Recurrent Adult Immunoblastic Large Cell Lymphoma
  • Recurrent Childhood Lymphoblastic Lymphoma
  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Recurrent Adult Acute Lymphoblastic Leukemia
  • Secondary Myelodysplastic Syndromes
  • Childhood Immunoblastic Large Cell Lymphoma
  • Childhood Myelodysplastic Syndromes
  • Recurrent Childhood Acute Lymphoblastic Leukemia
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
  • Recurrent Grade 2 Follicular Lymphoma
  • Waldenstrom Macroglobulinemia
  • Recurrent Childhood Grade III Lymphomatoid Granulomatosis
  • Secondary Myelofibrosis
  • Aplastic Anemia
  • Childhood Acute Myeloid Leukemia in Remission
  • Childhood Grade III Lymphomatoid Granulomatosis
  • Wiskott- Aldrich Syndrome
  • Adult Grade III Lymphomatoid Granulomatosis
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Adult Acute Myeloid Leukemia
  • Childhood Acute Lymphoblastic Leukemia in Remission
  • Previously Treated Myelodysplastic Syndromes
  • Splenic Marginal Zone Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Adult Nasal Type Extranodal NK/T-cell Lymphoma
  • Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
  • Refractory Multiple Myeloma
  • Recurrent Adult Hodgkin Lymphoma
  • Congenital Amegakaryocytic Thrombocytopenia
  • Peripheral T Cell Lymphoma
  • Severe Combined Immunodeficiency
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