Clinical trial · Interventional
Trial of Daily Pulse Interleukin-2 With Famotidine in Acute Myelogenous Leukemia
Phase II Trial of Daily Pulse Interleukin-2 With Famotidine in Acute Myelogenous Leukemia
NCT01289678CI-TRIAL-00040570terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unable to meet accrual goals
Summary
Brief summary (as posted)
Assess the immunotherapy benefit of interleukin-2 in acute myelogenous leukemia treatment during lymphocyte recovery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interleukin-2 | Drug | Aldesleukin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- interleukin-2
- description
- interleukin-2 therapy during lymphocyte recovery
- interventionNames
- Drug: Interleukin-2
Primary outcomes (1)
- measure
- Event-free Survival
- timeFrame
- 3 years
- description
- Event-free survival (EFS) = all patients; measured from the date of entry onto study until treatment failure, AML relapse, or death
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.