Donor Natural Killer Cells and Donor Stem Cell Transplant in Treating Patients With High Risk Myeloid Malignancies
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 72
Summary
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Acute Erythroid Leukemia
- Acute Megakaryoblastic Leukemia
- Acute Myeloid Leukemia
- Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
- Acute Myeloid Leukemia in Remission
- Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Therapy-Related Myelodysplastic Syndrome
- Myelodysplastic Syndrome
- Therapy-Related Acute Myeloid Leukemia
- Blasts Under 20 Percent of Bone Marrow Nucleated Cells
- Blasts Under 20 Percent of Peripheral Blood White Cells
- Chronic Myelomonocytic Leukemia
- High Risk Myelodysplastic Syndrome
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 7 years and 65 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. Assess the safety of infusing ex vivo expanded natural killer (NK) cells in patients receiving busulfan-fludarabine phosphate (fludarabine) with an allogeneic human leukocyte antigen (HLA) matched hematopoietic transplantation for myeloid malignancies. Two sources of NK cells ...
PRIMARY OBJECTIVES: I. Assess the safety of infusing ex vivo expanded natural killer (NK) cells in patients receiving busulfan-fludarabine phosphate (fludarabine) with an allogeneic human leukocyte antigen (HLA) matched hematopoietic transplantation for myeloid malignancies. Two sources of NK cells could be studied, depending on what donor source is available: cells from the HLA matched related donor or cells from an unrelated cord blood unit. II. For each source of NK cells: the maximum tolerated cell dose; the phenotype and function of the ex vivo expanded NK cells and their survival in vivo; the rate of engraftment, graft-vs.-host disease (GVHD), immune reconstitution, relapse rates and survival for patients receiving this regimen will be determined. OUTLINE: This is a phase I, dose-escalation study of NK cells followed by a phase II study. Patients receive fludarabine phosphate intravenously (IV) over 1 hour and busulfan IV over 3 hours on days -13 to -10. Patients then receive allogeneic CD56-positive CD3-negative natural killer cells IV over 1 hour on day -8. Patients also receive aldesleukin subcutaneously (SC) once daily (QD) on days -8 to -4. Patients then undergo allogeneic peripheral blood stem cell (PBSC) transplant on day 0.
Tracking Information
- NCT #
- NCT01823198
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Richard E Champlin M.D. Anderson Cancer Center
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