Clinical trial · Interventional
AML1-ETO Acute Myeloid Leukemia With Fludarabine and Cytarabine Chemotherapy
A Randomized Comparison of Fludarabine in Combination With Cytarabine Versus High -Dose Cytarabine in Post-remission Therapy for AML1-ETO Acute Myeloid Leukemia
NCT02024308CI-TRIAL-00013259unknownPhase 4ClinicalTrials.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 purpose of the study is to determine whether Fludarabine in combination with cytarabine is more effective than high-dose cytarabine in post-remission therapy for patients with AML1-ETO acute myeloid leukemia.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| AML1-ETO Fusion Protein Expression | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytarabine | Drug | Cytarabine | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fludarabine
- description
- The patients in experimental arm should receive the consolidation chemotherapy regimen with fludarabine and cytarabine. The dosage of fludarabine is 30mg/m2/d for 5 days intravenously and cytarabine is 1.4g/m2/d for 5 days intravenously.
- interventionNames
- Drug: Fludarabine
- Drug: Cytarabine
- type
- ACTIVE_COMPARATOR
- label
- HD-Arac
- description
- The patients in control arm should receive the consolidation chemotherapy regimen with high-dose cytarabine. The dosage of cytarabine is 2000mg/m2/12h for 3 days (1,3,5) intravenously.
- interventionNames
- Drug: Cytarabine
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Clinical and laboratory diagnosis of AML1-ETO positive acute myeloid leukemia * In status of complete remission after one to two courses of induction therapy with DA(Daunorubicin 60mg/m2/d for 3 days, cytarabine 100mg/m2/d for 5-7days) regimen * ECOG (Eastern Cooperative Oncology Group) score: \<2 Exclusion Criteria: * Serious liver/ kidney dysfunction * Cardiac function level: 2 above * Female in pregnancy or lactation * With serious infection diseases or other diseases
References
Publications (0)
Data not yet available
No reference posted for this study.