Clinical trial · Interventional
Combination Chemotherapy Plus Biological Therapy in Treating Patients With Acute Myelogenous Leukemia
Treatment Protocol for Patients With Standard Risk Acute Myelogenous Leukemia and Its Variants: Induction Using High-Dose Cytarabine, Mitoxantrone and Ethyol; Consolidation With Cytarabine and Idarubicin and Maintenance With 13 Cis Retinoic Acid and Alpha Interferon
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No enrollment
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cell from growing. Combining more than one chemotherapy drug with biological therapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, isotretinoin, and interferon alfa in treating patients who have acute myelogenous 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 (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| amifostine trihydrate | Drug | — | UNRESOLVED |
| bromodeoxyuridine | Drug | — | UNRESOLVED |
| cytarabine | Drug | Cytarabine | ALIAS |
| idarubicin | Drug | Idarubicin | ALIAS |
| idoxuridine | Drug | — | UNRESOLVED |
| isotretinoin | Drug | — | UNRESOLVED |
| mitoxantrone hydrochloride | Drug | Mitoxantrone | ALIAS |
| recombinant interferon alfa | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically confirmed previously untreated acute myelogenous leukemia (AML) FAB M1, M2, M4, M5, M6, or M7 No AML secondary to chemotherapy, radiation therapy, or toxic agents No history of myelodysplastic syndromes If possible, patient should be enrolled on protocol RUSH-CYL-9003 PATIENT CHARACTERISTICS: Age: 70 and under Performance status: 0-3 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin greater than 2.0 mg/dL and no greater than 3.0 mg/dL allowed with 50% reduction in drug doses Renal: Creatinine less than 3.0 mg/dL Cardiovascular: No overt congestive heart failure No uncontrollable ventricular arrhythmias No uncontrollable hypertension If cardiac ejection fraction is less than 45% of predicted, an echocardiogram and a cardiac consult must be obtained to ascertain cardiac tolerance of anthracycline therapy Neurological: No cerebellar dysfunction Other: Fever, infection, or other complications of disease allowed Not pregnant or nursing Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior interferon At least 2 weeks since prior hematopoietic growth factors (including erythropoietin) Chemotherapy: At least 2 weeks since prior chemotherapy Endocrine therapy: At least 2 weeks since prior steroids Radiotherapy: Not specified Surgery: Not specified Other: At least 2 weeks since prior retinoids
References
Publications (0)
Data not yet available