Trial of Daily Pulse Interleukin-2 With Famotidine in Acute Myelogenous Leukemia
- Registration Number
- NCT01289678
- Lead Sponsor
- Leo W. Jenkins Cancer Center
- Brief Summary
Assess the immunotherapy benefit of interleukin-2 in acute myelogenous leukemia treatment during lymphocyte recovery.
- Detailed Description
Upon lymphocyte recovery after myeloablative induction standard chemotherapy pulse Interleukin-2 administered
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
- Confirmed hematopathology diagnosis of AML receiving marrow suppressive treatment
- Total WBC recovery of 500 mm3 prior to IL-2 treatment
- Platelet count of at least 20,000 mm3 prior to starting IL-2 treatment
- Active infection controlled prior to starting IL-2 treatment
- Stable systolic blood pressure > 90mm Hg prior to starting IL-2 treatment
- O2 saturation >90% prior to starting treatment
- Stable cardiopulmonary status prior to starting IL-2 treatment
- Serum creatinine < or equal to 2.0 mg/dl
- Total bilirubin and AST <3x upper limits normal
Exclusion Criteria
- Acute Promyelocytic Leukemia
- Active thrombocytopenic bleeding
- Cardiac ejection fraction below 45%
- Pregnancy and/or lactation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description interleukin-2 Interleukin-2 interleukin-2 therapy during lymphocyte recovery
- Primary Outcome Measures
Name Time Method Event-free Survival 3 years Event-free survival (EFS) = all patients; measured from the date of entry onto study until treatment failure, AML relapse, or death
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Leo W. Jenkins Cancer Center
🇺🇸Greenville, North Carolina, United States