Clinical trial · Interventional
Intravenous (IV) Decitabine and Oral Bexarotene for Acute Myelogenous Leukemia (AML)
A Phase I Dose Escalation Study of Intravenous Decitabine in Combination With Oral Bexarotene in Patients With Acute Myeloid Leukemia (AML)
NCT01001143CI-TRIAL-00015247AMLcompletedPhase 1ClinicalTrials.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)
The main objective is to determine the safety and tolerability of combination decitabine and bexarotene during four cycles of therapy.
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, Myeloid, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bexarotene | Drug | Bexarotene | ALIAS |
| Decitabine | Drug | Decitabine | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Dose Level 1
- description
- Decitabine 20 mg/m2 IV days 3-7 of cycle 1 and days 1-5 of subsequent cycles. Each cycle is 28 days. Bexarotene 100 mg/m2 PO daily for each 28 day cycle.
- interventionNames
- Drug: Decitabine
- Drug: Bexarotene
- type
- EXPERIMENTAL
- label
- Dose Level 2
- description
- Decitabine 20 mg/m2 IV days 3-7 of cycle 1 and days 1-5 of subsequent cycles. Each cycle is 28 days. Bexarotene 200 mg/m2 PO daily for each 28 day cycle.
- interventionNames
- Drug: Decitabine
- Drug: Bexarotene
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * AML with bone marrow blasts ≥ 20%. * Relapsed disease after 1 or more lines of prior salvage chemotherapy and any FAB-AML, or * Diagnosis of AML and age ≥ 60 and not a candidate for cytotoxic chemotherapy and any FAB-AML except FAB-M3. * Performance status ≤ 2. * Age ≥ 18 years. Exclusion Criteria: * Peripheral white blood cell count (WBC) \> 10,000/microliter. * Total bilirubin \> 1.5 x normal. * AST/ALT \> 2.5 x normal. * Serum creatinine \> 2 x normal. * Fasting serum triglyceride \> 1,000 mg/dL. * Active or poorly controlled graft vs host disease (GVHD). * Pregnant or nursing. * Known CNS leukemia. * History of positive HIV serology. * History of positive Hepatitis C serology. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, congestive heart failure of NYHA class 3 or 4, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements. * Chemotherapy within 21 days of enrollment. * Radiation therapy within 14 days of enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.