A Two-Step Approach to Reduced Intensity Bone Marrow Transplant for Patients With Hematological Malignancies
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 30
Summary
- Conditions
- Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
- Adult Acute Myeloid Leukemia With Del(5q)
- Adult Acute Lymphoblastic Leukemia in Remission
- Essential Thrombocythemia
- Childhood Acute Myeloid Leukemia in Remission
- T-cell Large Granular Lymphocyte Leukemia
- Recurrent Adult Acute Lymphoblastic Leukemia
- Adult Acute Myeloid Leukemia in Remission
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Mastocytosis
- Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
- Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
- Chronic Myelomonocytic Leukemia
- Recurrent Childhood Acute Myeloid Leukemia
- Recurrent Marginal Zone Lymphoma
- Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
- Previously Treated Myelodysplastic Syndromes
- Recurrent Adult Acute Myeloid Leukemia
- Primary Myelofibrosis
- Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
- Recurrent/Refractory Childhood Hodgkin Lymphoma
- Refractory Anemia With Ringed Sideroblasts
- Nodal Marginal Zone B-cell Lymphoma
- Recurrent Adult Grade III Lymphomatoid Granulomatosis
- Recurrent Small Lymphocytic Lymphoma
- Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
- Adult Nasal Type Extranodal NK/T-cell Lymphoma
- Polycythemia Vera
- Juvenile Myelomonocytic Leukemia
- Recurrent Grade 2 Follicular Lymphoma
- Recurrent Adult Hodgkin Lymphoma
- Refractory Multiple Myeloma
- Recurrent Childhood Acute Lymphoblastic Leukemia
- Chronic Neutrophilic Leukemia
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
- Splenic Marginal Zone Lymphoma
- Waldenstrom Macroglobulinemia
- Aplastic Anemia
- Childhood Myelodysplastic Syndromes
- Refractory Anemia
- Recurrent Grade 1 Follicular Lymphoma
- Childhood Acute Lymphoblastic Leukemia in Remission
- Secondary Myelodysplastic Syndromes
- Chronic Eosinophilic Leukemia
- Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
- Recurrent Mycosis Fungoides/Sezary Syndrome
- Refractory Hairy Cell 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 OBJECTIVES: I. To compare the overall survival (OS) rate at 2 years post treatment using the Jefferson 2 step reduced intensity conditioning (RIC) approach in patients with haploidentical family donors with hematological malignancies in morphological or radiographic remission or with chemose...
PRIMARY OBJECTIVES: I. To compare the overall survival (OS) rate at 2 years post treatment using the Jefferson 2 step reduced intensity conditioning (RIC) approach in patients with haploidentical family donors with hematological malignancies in morphological or radiographic remission or with chemosensitive, indolent diseases to historical OS rates in similar populations after RIC matched donor HSCT as reported in the literature. SECONDARY OBJECTIVES: I. To compare the treatment-related mortality (TRM) rate at 2 years for patients treated on this study to the historical TRM rates of patients undergoing RIC matched-sibling HSCT as reported in the literature. II. To compare the 2 year relapse rates and relapse related mortality of patients with myeloid diseases to that of patients with lymphoid diseases who are treated on this Thomas Jefferson University (TJU) RIC 2 step approach. III. To determine the incidence and severity of graft-versus-host disease (GVHD) in patients undergoing treated on the TJU RIC 2 step approach. IV. To evaluate engraftment rates and lymphoid reconstitution in patients treated on the TJU RIC 2 step approach. V. To evaluate the incidence of TRM at 100 days in patients treated on the TJU RIC 2 step approach. OUTLINE: REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate intravenously (IV) over 60 minutes on days -11 to -8 and bulsufan IV over 3 hours on days -10 to -9. Patients undergo total body irradiation (TBI) on day -6. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2. TRANSPLANTATION: Patients undergo donor lymphocyte infusion (DLI) on day -6 and cluster of differentiation (CD)-34+ allogeneic peripheral blood stem cell transplantation (PBSCT) on day 0. GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or orally (PO) with taper beginning on day 42. Patients also receive mycophenolate mofetil IV twice daily (BID) on days -1 to 28. After completion of study treatment, patients are followed up periodically for 2 years.
Tracking Information
- NCT #
- NCT01384513
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Dolores Grosso, DNP, CRNP Sidney Kimmel Cancer Center at Thomas Jefferson University Principal Investigator: Neal Flomenberg, MD Sidney Kimmel Cancer Center at Thomas Jefferson University
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