Clinical trial · Interventional
High Dose Ara-C (HDAC) and Interleukin-2 (IL-2) for Patients With Acute Myelogenous Leukemia (AML)
High-Dose Ara-C Followed by Continuous Infusion Interleukin-2 for Acute Myelogenous Leukemia in First Remission
NCT00136448CI-TRIAL-00004551completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will add interleukin-2 (IL-2) to a regimen of post-remission therapy consisting of high-dose ara-C. Patients with AML in first remission will receive 3 cycles of high-dose ara-C followed by continuous infusion and bolus interleukin-2 (IL-2). We, the researchers at the Dana-Farber Cancer Institute, plan to evaluate the immunologic effects of such treatment in these patients.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytosine arabinoside (ara-C) | Drug | Cytarabine | ALIAS |
| daunomycin | Drug | Daunorubicin | ALIAS |
| interleukin-2 | Drug | Aldesleukin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The primary purpose of this study is to evaluate the ability of IL-2 to generate cytotoxic and inhibitory activity against cryopreserved autologous leukemic myeloblasts obtained at the time of diagnosis.
Secondary outcomes (3)
- measure
- To evaluate the safety of continuous infusion IL-2 with intermittent IL-2 boluses in patients with AML who have received 3 cycles of post-remission intensification therapy with high-dose ara-C
- measure
- To assess additional immunologic effects of IL-2
- measure
- To obtain preliminary data regarding the rate of disease relapse
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have AML based on French-American-British (FAB) criteria. * Patients must have a total bilirubin of \< 2.0 mg/dL, SGOT \< 90 IU/mL, alkaline phosphatase \< 250 U/mL and a serum creatinine \< 2.0 mg/dL. * Age 18 years or greater. Exclusion Criteria: * History of an antecedent hematologic malignancy such as myelodysplastic syndromes (MDS). * Uncontrolled infection. * History of a previous or concomitant malignancy other than non-melanoma skin cancer. * Evidence of central nervous system (CNS) leukemia. * Current use of corticosteroids. * Prior treatment for AML, other than hydroxyurea.
References
Publications (0)
Data not yet available
No reference posted for this study.