NCT02395822CompletedPhase 2
MT2014-25: Haploidentical Donor Natural Killer (NK) Cell Infusion With Subcutaneous Recombinant Human IL-15 (rhIL-15) in Adults With Refractory or Relapsed Acute Myelogenous Leukemia (AML)
Masonic Cancer Center, University of Minnesota2 sites in 1 country17 target enrollmentStarted: October 1, 2015Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 17
- Locations
- 2
- Primary Endpoint
- < 5% Marrow Blast, no Circulating Peripheral Blasts and Neutrophil Count of > 1 x 10^9/L
Study Overview
Brief Summary
A phase II trial of CD3/CD19 depleted, IL-15 activated, donor natural killer (NK) cells in adults and subcutaneous IL-15 given after a preparative regimen for the treatment of relapsed or refractory acute myelogenous leukemia (AML). The primary objective is to study the potential efficacy of NK cells and IL-15 to achieve complete remission while maintaining safety.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Preparative Regimen and SubQ rHuIL-15
Experimental
Preparative Regimen of Fludarabine and Cyclophosphamide
IL-15 Activation of Donor NK Cells:
IL-15 to Facilitate NK Cell Survival and Expansion
Intervention: IL-15 (Biological)
Outcomes
Primary Outcomes
< 5% Marrow Blast, no Circulating Peripheral Blasts and Neutrophil Count of > 1 x 10^9/L
Time Frame: Day 42 post NK cell infusion
Without platelet recovery
Secondary Outcomes
- In Vivo Expansion (>100) of NK Cells (Defined at CD56+/CD3- Lymphocytes)(Day 14 post NK cell infusion)
- Proportion of Patients Experiencing Grade, 3, 4, and 5 Toxicities (Assessed by CTCAE v. 4)(Days 1-5 and Days 8-12, 24 hours after the last IL-15 dose, Day +28, Day +42)
- Treatment Related Mortality(6 months post-therapy)
- Number of Subjects Achieving Complete Response, Defined as in Vivo Donor Derived NK Cell Expansion of > 100 Donor Derived NK Cells.(Day 42 post NK cell infusion)
Investigators
Study Sites (2)
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