Clinical trial · Interventional
Everolimus, Cytarabine, and Daunorubicin in Treating Patients With Relapsed Acute Myeloid Leukemia
Phase I Study Evaluating the Chemosensitizing Effect of Everolimus Administered With Cytarabine and Daunorubicin in Patients With Acute Myeloid Leukemia in Relapse
- 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)
RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Everolimus may help cytarabine and daunorubicin work better by making cancer cells more sensitive to chemotherapy. Giving everolimus together with cytarabine and daunorubicin may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when given together with cytarabine and daunorubicin in treating patients with relapsed acute myeloid leukemia.
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 |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytarabine | Drug | Cytarabine | ALIAS |
| daunorubicin hydrochloride | Drug | Daunorubicin | ALIAS |
| everolimus | Drug | Everolimus | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Maximum tolerated dose of everolimus
- measure
- Toxicity
Secondary outcomes (2)
- measure
- Activation of PI3K/AKT and mTORC 1 in leukemic blasts
- measure
- Pharmacokinetics of everolimus
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Inclusion criteria: * Diagnosis of de novo or secondary acute myeloid leukemia meeting the following criterion: * Relapse \> 1 year after obtaining complete remission (any prior treatment allowed) Exclusion criteria: * Philadelphia chromosome-positive disease in blast crisis * FAB M3, M6, or M7 disease PATIENT CHARACTERISTICS: Inclusion criteria: * Life expectancy ≥ 4 weeks * Transaminases ≤ 5 times normal * Creatinine ≤ 2 times normal * Bilirubin ≤ 3 times normal (except if visceral involvement present) * Alkaline phosphatase or gamma-glutamyltransferase ≤ 5 times normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients of must use effective contraception during and for ≥ 28 days after completion of study therapy Exclusion criteria: * FEV1 \< 30% * Active uncontrolled or viral pulmonary infection * Serious psychiatric disorders not related to leukemia or any condition that would prohibit comprehension of the study * HIV-positive * Other concurrent malignancy except noninvasive skin cancer or carcinoma in situ * Patients who are incarcerated or under supervision or trusteeship PRIOR CONCURRENT THERAPY: Inclusion criteria: * See Disease Characteristics Exclusion criteria: * Prior experimental medication within the past 4 weeks
References
Publications (0)
Data not yet available