Clinical trial · Interventional
Pravastatin, Idarubicin, and Cytarabine in Treating Patients With Acute Myeloid Leukemia
A Phase I Trial Evaluating the Effect of the Addition of HMGCoA-Reductase Inhibition With Pravastatin to Salvage Chemotherapy Idarubicin-HDAC in Patients With Relapsed or Refractory Acute Myelogenous Leukemia
- 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 idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Pravastatin may help idarubicin and cytarabine work better by making cancer cells more sensitive to the drugs. Giving pravastatin together with idarubicin and cytarabine may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of pravastatin when given together with idarubicin and cytarabine in treating patients with 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytarabine | Drug | Cytarabine | ALIAS |
| idarubicin | Drug | Idarubicin | ALIAS |
| pravastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Biological efficacy by measuring surrogate end-points, including cellular cholesterol, messenger RNAs encoding cholesterol synthesis and cholesterol import regulators, and specific protein farnesylation
- measure
- Leukemia cell apoptosis
- measure
- Maximum tolerated dose (MTD) of pravastatin
- measure
- Maximal biological effect on cholesterol metabolism achieved with or without the MTD of pravastatin
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of acute myeloid leukemia (AML) meeting 1 of the following criteria: * Newly diagnosed disease (MDACC patients only) * In first or second relapse AND scheduled to receive first salvage therapy * Primary refractory disease after prior induction therapy for newly diagnosed disease PATIENT CHARACTERISTICS: Age * Over 18 Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * AST or ALT ≤ 2 times normal * Alkaline phosphatase ≤ 2 times normal * Bilirubin \< 2.0 mg/dL * No acute or chronic hepatic impairment Renal * Creatinine \< 1.5 times normal (unless secondary to acute myeloid leukemia) Cardiovascular * Ejection fraction (EF) ≥ 45% by MUGA or 2-D echocardiogram * Patients who have an EF \< 45% OR cardiac symptoms must be evaluated and cleared by cardiology to be eligible for study entry * No cardiac contraindication to idarubicin Other * Not pregnant or nursing * Fertile patients must use effective contraception * HIV negative * No uncontrolled or life threatening infection * No known intolerance to study drugs * Must be able to safely tolerate the 3-day delay between the start of pravastatin and the start of chemotherapy PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * No other concurrent HMG-CoAR inhibitors, including any of the following: * Atorvastatin * Fluvastatin * Lovastatin * Rosuvastatin * Simvastatin * No concurrent non-HMG-CoAR inhibitors to lower cholesterol * No concurrent use of any of the following medications: * Bezafibrate * Clofibrate * Fenofibrate * Gemfibrozil * Cholestipol * Cholestyramine resin * Colesevelam * Ezetimibe * Biphenabid * Niacin
References
Publications (0)
Data not yet available