NK Cells in Cord Blood Transplantation
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Biphenotypic Leukemia
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Acute Lymphoblastic Leukemia in Remission
- Recurrent Small Lymphocytic Lymphoma
- Refractory Acute Lymphoblastic Leukemia
- Secondary Acute Myeloid Leukemia
- Recurrent Chronic Lymphocytic Leukemia
- Refractory Small Lymphocytic Lymphoma
- Acute Myeloid Leukemia in Remission
- Therapy-Related Myelodysplastic Syndrome
- Recurrent Acute Lymphoblastic Leukemia
- Recurrent Hodgkin Lymphoma
- Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Refractory Chronic Lymphocytic Leukemia
- DS Stage II Plasma Cell Myeloma
- Refractory Non Hodgkin Lymphoma
- Recurrent Non-Hodgkin Lymphoma
- Therapy-Related Acute Myeloid Leukemia
- DS Stage III Plasma Cell Myeloma
- Refractory Hodgkin Lymphoma
- High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
- ISS Stage II Plasma Cell Myeloma
- ISS Stage III Plasma Cell Myeloma
- Myelodysplastic Syndrome
- Recurrent Acute Myeloid Leukemia
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 75 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To evaluate the feasibility and safety of ex-vivo expanded cord blood (CB) natural killer (NK) cells with double CB transplantation in patients with hematological malignancies. SECONDARY OBJECTIVES: I. To monitor engraftment, chimerism, graft versus host disease, and immune re...
PRIMARY OBJECTIVES: I. To evaluate the feasibility and safety of ex-vivo expanded cord blood (CB) natural killer (NK) cells with double CB transplantation in patients with hematological malignancies. SECONDARY OBJECTIVES: I. To monitor engraftment, chimerism, graft versus host disease, and immune reconstitution in patients receiving expanded CB NK cell therapy. II. To estimate the time to platelet recovery and the time to absolute neutrophil count (ANC) recovery. III. To estimate overall survival and disease free survival at one year. IV. To study the in-vivo persistence of cord blood NK cells. OUTLINE: PREPARATIVE REGIMEN: Patients are assigned to 1 of 2 treatment plans: TREATMENT PLAN 1: Patients receive high-dose lenalidomide orally (PO) once daily (QD) on days -8 to -2, fludarabine phosphate IV over 1 hour on days -7 to -4, and melphalan IV over 30 minutes on day -4. CD20 positive patients also receive rituximab intravenously (IV) over 6 hours on days -8 to -4. TREATMENT PLAN 2: Patients receive high-dose lenalidomide PO QD on days -7 to -2, cyclophosphamide IV over 3 hours on day -7, and undergo total body irradiation (TBI) on day -3. Patients also receive rituximab and fludarabine phosphate as in Treatment Plan 1. NK CELL INFUSION: All patients receive ex-vivo expanded cord blood NK cells IV over 30 minutes on day -2. TRANSPLANT: All patients undergo allogeneic umbilical cord blood transplant on day 0. GRAFT-VERSUS-HOST DISEASE (GVHD) PROPHYLAXIS: All patients receive tacrolimus IV or PO on days -2 to 180 followed by taper and mycophenolate mofetil IV over 2 hours or PO thrice daily (TID) on days -3 to 100. After completion of study treatment, patients are followed up at 3, 6, and 12 months.
Tracking Information
- NCT #
- NCT01619761
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Chitra Hosing M.D. Anderson Cancer Center
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