MT2014-25: Haplo NK With SQ IL-15 in Adult Relapsed or Refractory AML Patients
Phase 2
Completed
- Conditions
- Acute Myelogenous Leukemia
- Interventions
- Biological: IL-15
- Registration Number
- NCT02395822
- Lead Sponsor
- Masonic Cancer Center, University of Minnesota
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Preparative Regimen and SubQ rHuIL-15 IL-15 Preparative Regimen of Fludarabine and Cyclophosphamide IL-15 Activation of Donor NK Cells: IL-15 to Facilitate NK Cell Survival and Expansion
- Primary Outcome Measures
Name Time Method < 5% Marrow Blast, no Circulating Peripheral Blasts and Neutrophil Count of > 1 x 10^9/L Day 42 post NK cell infusion Without platelet recovery
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Masonic Cancer Center at University of Minnesota
🇺🇸Minneapolis, Minnesota, United States