Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
50

Summary

Conditions
  • Adult Nasal Type Extranodal NK/T-cell Lymphoma
  • Adult Acute Lymphoblastic Leukemia in Remission
  • Accelerated Phase Chronic Myelogenous Leukemia
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Intraocular Lymphoma
  • Recurrent Mycosis Fungoides/Sezary Syndrome
  • Recurrent Adult Lymphoblastic Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Cutaneous B-cell Non-Hodgkin Lymphoma
  • Recurrent Childhood Lymphoblastic Lymphoma
  • Chronic Myelomonocytic Leukemia
  • Chronic Phase Chronic Myelogenous Leukemia
  • Previously Treated Myelodysplastic Syndromes
  • Adult Acute Myeloid Leukemia With Del(5q)
  • Hepatosplenic T Cell Lymphoma
  • Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
  • Testicular Lymphoma
  • Nodal Marginal Zone B-cell Lymphoma
  • T-cell Large Granular Lymphocyte Leukemia
  • Anaplastic Large Cell Lymphoma
  • Childhood Myelodysplastic Syndromes
  • Noncutaneous Extranodal Lymphoma
  • Recurrent Childhood Acute Myeloid Leukemia
  • Recurrent Grade 1 Follicular Lymphoma
  • Secondary Acute Myeloid Leukemia
  • Angioimmunoblastic T Cell Lymphoma
  • Peripheral T Cell Lymphoma
  • Refractory Anemia With Excess Blasts in Transformation
  • Relapsing Chronic Myelogenous Leukemia
  • Recurrent Adult Grade III Lymphomatoid Granulomatosis
  • Refractory Hairy Cell Leukemia
  • Blastic Phase Chronic Myelogenous Leukemia
  • Childhood Acute Lymphoblastic Leukemia in Remission
  • Small Intestine Lymphoma
  • Childhood Burkitt Lymphoma
  • Childhood Immunoblastic Large Cell Lymphoma
  • Refractory Cytopenia With Multilineage Dysplasia
  • Childhood Nasal Type Extranodal NK/T-cell Lymphoma
  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Recurrent Adult Immunoblastic Large Cell Lymphoma
  • Post Transplant Lymphoproliferative Disorder
  • Recurrent Adult Hodgkin Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Childhood Diffuse Large Cell Lymphoma
  • Essential Thrombocythemia
  • Recurrent Childhood Large Cell Lymphoma
  • Recurrent Adult Acute Myeloid Leukemia
  • Refractory Anemia With Excess Blasts
  • Refractory Multiple Myeloma
  • Juvenile Myelomonocytic Leukemia
  • Recurrent Childhood Grade III Lymphomatoid Granulomatosis
  • Recurrent Mantle Cell Lymphoma
  • Polycythemia Vera
  • de Novo Myelodysplastic Syndromes
  • Waldenstrom Macroglobulinemia
  • Recurrent Childhood Anaplastic Large Cell Lymphoma
  • Splenic Marginal Zone Lymphoma
  • Childhood Chronic Myelogenous Leukemia
  • Recurrent Adult Burkitt Lymphoma
  • Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
  • Primary Myelofibrosis
  • Recurrent Adult Diffuse Mixed Cell Lymphoma
  • Recurrent Adult T-cell Leukemia/Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Childhood Small Noncleaved Cell Lymphoma
  • Recurrent/Refractory Childhood Hodgkin Lymphoma
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 OBJECTIVE: 1. To compare the rate of disease-free survival (DFS) at 1 year post hematopoietic stem cell transplant (HSCT) in patients undergoing HSCT treated on this successor Thomas Jefferson University (TJU) 2 Step reduced intensity conditioning (RIC) haploidentical regimen and compare it ...

PRIMARY OBJECTIVE: 1. To compare the rate of disease-free survival (DFS) at 1 year post hematopoietic stem cell transplant (HSCT) in patients undergoing HSCT treated on this successor Thomas Jefferson University (TJU) 2 Step reduced intensity conditioning (RIC) haploidentical regimen and compare it with that of the initial 2 Step RIC regimen. SECONDARY OBJECTIVES: To assess the 100 day regimen-related mortality (RRM) in patients undergoing HSCT on this treatment protocol. To determine the incidence and severity of graft-versus-host disease (GVHD) in patients undergoing treatment on this regimen. To evaluate engraftment rates and lymphoid reconstitution in patients treated on this trial. To assess overall survival at 1 and 3 years past HSCT in patients treated on this trial. OUTLINE: REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate intravenously (IV) over 60 minutes on days -15 to -12, thiotepa IV over 2 hours on days -15 to -13, donor lymphocyte infusion (DLI) on day -6, and cyclophosphamide IV over 2 hours on days -3 and -2. Patients also undergo total-body irradiation (TBI) on day -10. TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant (PBSCT) on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV on days -1 to 42 followed by taper and mycophenolate mofetil IV twice daily (BID) on days -1 to 28. After completion of study treatment, patients are followed up periodically.

Tracking Information

NCT #
NCT01760655
Collaborators
Not Provided
Investigators
Principal Investigator: Dolores Grosso, RN, CRNP, DNP Thomas Jefferson University Principal Investigator: Neal Flomenberg, MD Thomas Jefferson University