Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Acute Promyelocytic Leukemia
A Pilot Study of Arsenic Trioxide-Based Consolidation Therapy for the Primary Treatment of Acute Promyelocytic Leukemia
NCT00276601CI-TRIAL-00014295completedPhase 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)
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy 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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| arsenic trioxide | Drug | Arsenic Trioxide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| daunorubicin hydrochloride | Drug | Daunorubicin | ALIAS |
| mercaptopurine | Drug | Mercaptopurine | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| tretinoin | Drug | Tretinoin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Disease-free survival at 2 and 5 years after study completion
- measure
- Safety of arsenic trioxide following cytarabine and anthracycline immediately after study completion
Secondary outcomes (1)
- measure
- Validate peripheral blood real-time PCR for minimal disease monitoring as measured by real-time PCR for PML-RARalpha monthly for two years after study completion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 74 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of acute promyelocytic leukemia (APL) by morphologic and flow cytometric documentation (high orthogonal light scatter, lack of HLA-DR expression)
* Patients with classical APL as well as the microgranular variant (M3V) are eligible
* In cases where the diagnosis is unclear, consultation with a hematopathologist is required before enrolling the patient in the study
* Patients found to have cytogenetic abnormalities that do not produce the PML-RARα gene rearrangement will be removed from study and will not be included in data analysis
PATIENT CHARACTERISTICS:
* Patients will not be excluded because of performance status or comorbid disease
* Premenopausal female patients must have a negative pregnancy test
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy for APL except hydroxyureaReferences
Publications (0)
Data not yet available
No reference posted for this study.