Personalized NK Cell Therapy After Chemotherapy and Cord Blood Transplant in Treating Patients With Myelodysplastic Syndrome, Leukemia, Lymphoma or Multiple Myeloma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Lymphoblastic Leukemia in Remission
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Acute Biphenotypic Leukemia
- Acute Lymphoblastic Leukemia
- Acute Myeloid Leukemia With Myelodysplasia-Related Changes
- Therapy-Related Myelodysplastic Syndrome
- Acute Myeloid Leukemia With Variant MLL Translocations
- Myelodysplastic Syndrome With Gene Mutation
- Recurrent Acute Myeloid Leukemia
- B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
- Recurrent Non-Hodgkin Lymphoma
- Chemotherapy-Related Leukemia
- Myelodysplastic Syndrome With Excess Blasts
- Refractory Adult Acute Lymphoblastic Leukemia
- ISS Stage II Plasma Cell Myeloma
- ISS Stage III Plasma Cell Myeloma
- Chronic Myelomonocytic Leukemia
- Recurrent Hodgkin Lymphoma
- Secondary Acute Myeloid Leukemia
- Myelodysplastic Syndrome
- Previously Treated Myelodysplastic Syndrome
- Refractory Acute Lymphoblastic Leukemia
- Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
- Recurrent Adult Acute Myeloid Leukemia
- Myelodysplastic/Myeloproliferative Neoplasm
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 15 years and 80 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. Progression-free survival (PFS) time. SECONDARY OBJECTIVES: I. Overall survival (OS) time. II. Transplant related mortality (TRM). III. Graft versus host disease (GVHD). IV. Infection OUTLINE: Patients are assigned to 1 of 3 preparative regimens. MYELOABLATIVE REGIMEN 1: Patie...
PRIMARY OBJECTIVES: I. Progression-free survival (PFS) time. SECONDARY OBJECTIVES: I. Overall survival (OS) time. II. Transplant related mortality (TRM). III. Graft versus host disease (GVHD). IV. Infection OUTLINE: Patients are assigned to 1 of 3 preparative regimens. MYELOABLATIVE REGIMEN 1: Patients receive anti-thymocyte globulin intravenously (IV) over 4 hours on days -9 and -8, fludarabine phosphate IV over 1 hour, clofarabine IV over 1 hour, and busulfan IV over 3 hours on days -7 to -4. Patients undergo total body irradiation (TBI) on day -3. NON-MYELOABLATIVE REGIMEN 2: Patients with cluster of differentiation (CD)20 positive malignancies receive rituximab IV over 6 hours on day -9. Patients receive anti-thymocyte globulin IV over 4 hours on days -8 and -7, fludarabine phosphate IV over 1 hour on days -6 to -3, and cyclophosphamide IV over 3 hours on day -6 and undergo TBI on day -1 at the discretion of the investigator(s). REDUCED INTENSITY REGIMEN 3: Patients receive anti-thymocyte globulin IV over 4 hours on days -7 and -6, fludarabine phosphate IV over 1 hour on days -5 to -2, and melphalan IV over 30 minutes on day -2. UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo umbilical cord blood transplantation on day 0. NK CELLS INFUSION: Patients receive NK cells IV over 30 minutes between days 30-180. After completion of study treatment, patients are followed up at 1, 7, 14, 28, 45, 60, and 100 days, and at 6, 9, and 12 months, and then yearly for up to 4 years.
Tracking Information
- NCT #
- NCT02727803
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Katy Rezvani M.D. Anderson Cancer Center
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