Reduced-Intensity Conditioning Before Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 50
Summary
- Conditions
- Adult Nasal Type Extranodal NK/T-cell Lymphoma
- Accelerated Phase Chronic Myelogenous Leukemia
- Refractory Anemia With Excess Blasts
- Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
- Recurrent Mycosis Fungoides/Sezary Syndrome
- Peripheral T Cell Lymphoma
- Recurrent Childhood Grade III Lymphomatoid Granulomatosis
- Recurrent Adult Hodgkin Lymphoma
- Childhood Myelodysplastic Syndromes
- Recurrent Childhood Large Cell Lymphoma
- Relapsing Chronic Myelogenous Leukemia
- Recurrent Small Lymphocytic Lymphoma
- Recurrent Adult Burkitt Lymphoma
- Recurrent Adult T-cell Leukemia/Lymphoma
- Intraocular Lymphoma
- Previously Treated Myelodysplastic Syndromes
- Recurrent Mantle Cell Lymphoma
- Recurrent Grade 3 Follicular Lymphoma
- Testicular Lymphoma
- de Novo Myelodysplastic Syndromes
- Adult Acute Lymphoblastic Leukemia in Remission
- Chronic Myelomonocytic Leukemia
- Refractory Hairy Cell Leukemia
- Waldenstrom Macroglobulinemia
- Recurrent/Refractory Childhood Hodgkin Lymphoma
- Refractory Cytopenia With Multilineage Dysplasia
- Recurrent Adult Diffuse Mixed Cell Lymphoma
- Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
- Primary Myelofibrosis
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Adult Acute Myeloid Leukemia With Del(5q)
- Anaplastic Large Cell Lymphoma
- Recurrent Adult Lymphoblastic Lymphoma
- Recurrent Childhood Acute Myeloid Leukemia
- Hepatosplenic T Cell Lymphoma
- Juvenile Myelomonocytic Leukemia
- Angioimmunoblastic T Cell Lymphoma
- Recurrent Adult Diffuse Large Cell Lymphoma
- Small Intestine Lymphoma
- Essential Thrombocythemia
- Recurrent Adult Grade III Lymphomatoid Granulomatosis
- Recurrent Grade 1 Follicular Lymphoma
- Refractory Anemia With Excess Blasts in Transformation
- T-cell Large Granular Lymphocyte Leukemia
- Blastic Phase Chronic Myelogenous Leukemia
- Recurrent Grade 2 Follicular Lymphoma
- Secondary Acute Myeloid Leukemia
- Childhood Nasal Type Extranodal NK/T-cell Lymphoma
- Post Transplant Lymphoproliferative Disorder
- Recurrent Childhood Lymphoblastic Lymphoma
- Splenic Marginal Zone Lymphoma
- Recurrent Childhood Small Noncleaved Cell Lymphoma
- Recurrent Adult Immunoblastic Large Cell Lymphoma
- Cutaneous B-cell Non-Hodgkin Lymphoma
- Childhood Acute Lymphoblastic Leukemia in Remission
- Recurrent Childhood Anaplastic Large Cell Lymphoma
- Recurrent Marginal Zone Lymphoma
- Chronic Phase Chronic Myelogenous Leukemia
- Nodal Marginal Zone B-cell Lymphoma
- Childhood Burkitt Lymphoma
- Childhood Diffuse Large Cell Lymphoma
- Polycythemia Vera
- Recurrent Adult Acute Myeloid Leukemia
- Childhood Immunoblastic Large Cell Lymphoma
- Refractory Multiple Myeloma
- Noncutaneous Extranodal Lymphoma
- Childhood Chronic Myelogenous Leukemia
- 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
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