Clinical trial · Interventional
Phase II Study of AS1411 Combined With Cytarabine to Treat Acute Myeloid Leukemia
An Open Label Randomized Controlled Dose Escalating Phase II Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia
NCT00512083CI-TRIAL-00002664completedPhase 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)
The overall aim of this study is to assess the efficacy and safety of AS1411, over a range of doses, when combined with cytarabine, in the treatment of patients with primary refractory or relapsed acute myeloid leukemia (AML).
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, Myeloid | Myeloid Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AS1411 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The prorportion of patients achieving a completel response (CR) after the first cycle of treatment in each treatment group
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * primary refractory or relapsed AML * confirmed diagnosis of AML (de novo or secondary) as defined by WHO classification (Vardiman 2002) * aged at least 18 years Exclusion Criteria: * initial diagnosis of acute promyelocytic leukemia as defined by French-American-British criteria (Bennett 1976) * patient in blast crisis stage of chronic myeloid leukemia * received high-dose cytarabine (total cumulative dose of \>6g/m sq)in last 6 months * interval of \<6 months between first onset of last complete remission and current relapse * those with primary refractory leukemia who have received more than three previous induction cycles * relapsed patients who have received more than three previous treatment regimens
References
Publications (0)
Data not yet available
No reference posted for this study.