Clinical trial · Interventional
Tretinoin and Arsenic Trioxide With or Without Idarubicin in Treating Patients With Acute Promyelocytic Leukemia
Phase II Study of Combined All-Trans Retinoic Acid and Arsenic Trioxide for Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of accrual
Summary
Brief summary (as posted)
RATIONALE: Tretinoin may help cancer cells become more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as arsenic trioxide and idarubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving tretinoin together with arsenic trioxide with or without idarubicin may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving tretinoin together with arsenic trioxide with or without idarubicin works in treating patients with acute promyelocytic 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 |
|---|---|---|---|
| arsenic trioxide | Drug | Arsenic Trioxide | ALIAS |
| idarubicin | Drug | Idarubicin | ALIAS |
| tretinoin | Drug | Tretinoin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tretinoin and Arsenic Trioxide With or Without Idarubicin
- description
- See Outline for details
- interventionNames
- Drug: arsenic trioxide
- Drug: idarubicin
- Drug: tretinoin
Primary outcomes (1)
- measure
- Molecular Remission Rate
- timeFrame
- 2 years
- description
- \# of patients with Complete Remission
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Morphologic diagnosis of acute promyelocytic leukemia (APL), confirmed by one of the following: * Demonstration of t(15;17) using conventional cytogenetics or fluorescence in situ hybridization (FISH) * Positive PML-RARα transcript by reverse transcriptase-polymerase chain reaction (RT-PCR) assay * Patients with CNS involvement by APL are eligible PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * Creatinine ≤ 2.0 mg/dL or creatinine clearance \> 60 mL/min * Bilirubin \< 2.0 mg/dL (unless attributed to Gilbert disease) * Alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN) * AST and ALT ≤ 2.5 ULN * LVEF ≥ 50% on echocardiogram or MUGA scan * QTc ≤ 500 msec on baseline ECG * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 4 months after the completion of study treatment * No active serious infections not controlled by antibiotics * No other concurrent active malignancy requiring immediate therapy * No clinically significant cardiac disease (New York Heart Association class III or IV heart disease), including chronic arrhythmias * No pulmonary disease * No other serious or life-threatening condition deemed unacceptable by the principal investigator PRIOR CONCURRENT THERAPY: * No prior treatment for APL
References
Publications (0)
Data not yet available