Clinical trial · Interventional
A Randomized Phase III Study of Intensive Consolidation With High Dose Cytosine Arabinoside in Acute Myelogenous Leukemia (AML-8B)
NCT01324063CI-TRIAL-00007440completedPhase 3ClinicalTrials.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: Patient abstract not available PURPOSE: Patient abstract not available
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| amsacrine | Drug | Amsacrine | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| daunorubicin hydrochloride | Drug | Daunorubicin | ALIAS |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Disease-free survival and overall survival in patients who achieve complete remission after induction
- measure
- Toxicity
- measure
- Quality of life
- measure
- Improved therapeutic results as measured by activation of leukemic cells into the cell cycle and/or acceleration of hematopoietic recovery
- measure
- Relative efficacy of autologous bone marrow therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Newly diagnosed, untreated acute myelogenous leukemia (AML), as follows: Any cytological type according to the FAB classification At least 30% blast cells in bone marrow smear required Secondary acute leukemia eligible, i.e.: AML cured Hodgkin's disease or other malignancy AML following exposure to alkylating agents or radiation The following are specifically excluded: Blast crisis of chronic myeloid leukemia Leukemia supervening after other myeloproliferative disease Leukemia supervening after overt myelodysplastic disorder (e.g., refractory anemia with excess blasts) of more than 6 months' duration PATIENT CHARACTERISTICS: Age: 45-60 Patients 10-45 are eligible for EORTC-06863 Performance status: Not specified Hematopoietic: Not specified Hepatic: No severe concomitant hepatic disease Renal: No severe concomitant renal disease Cardiovascular: No severe concomitant cardiac disease Other: No severe concomitant neurological disease No other progressive malignant disease PRIOR CONCURRENT THERAPY: Biologic therapy: No prior therapy Chemotherapy: No prior chemotherapy Endocrine therapy: No more than 7 days of corticosteroids for AML Radiotherapy: No prior radiotherapy Surgery: Not applicable
References
Publications (1)
- RESULTZittoun R, Suciu S, Mandelli F, de Witte T, Thaler J, Stryckmans P, Hayat M, Peetermans M, Cadiou M, Solbu G, Petti MC, Willemze R. Granulocyte-macrophage colony-stimulating factor associated with induction treatment of acute myelogenous leukemia: a randomized trial by the European Organization for Research and Treatment of Cancer Leukemia Cooperative Group. J Clin Oncol. 1996 Jul;14(7):2150-9. doi: 10.1200/JCO.1996.14.7.2150. PMID 8683249