Clinical trial · Interventional
A Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia
An Open-label Randomized Controlled Phase II Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia
NCT01034410CI-TRIAL-00004386terminatedPhase 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)
This is an open label randomized controlled phase II study of AS1411 combined with Cytarabine in the treatment of patients with primary refractory or relapsed acute myeloid 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 |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AS1411 | Drug | — | UNRESOLVED |
| Cytarabine | Drug | Cytarabine | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- cytarabine 2g/m2 bid Days 4-7
- interventionNames
- Drug: Cytarabine
- type
- EXPERIMENTAL
- label
- AS1411-40
- description
- AS1411 40mg/kg/day d1-7 plus cytarabine 2g/m2 bid days 4-7
- interventionNames
- Drug: AS1411
- Drug: Cytarabine
- type
- EXPERIMENTAL
- label
- AS1411-80
- description
- AS1411 80mg/kg/day d1-7, cytarabine 2g/m2 bid days 4- 7/ bid d4-7
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of AML as defined by the World Health Organization (WHO) classification (Vardiman 2009) * Primary refractory AML (defined as a failure to achieve a CR or CRi after therapy with curative intent) or AML in first relapse * ECOG Performance status 0, 1 or 2 * Age \> 18 and \< 70 years * For patients presenting with primary refractory AML, \> 20% blasts on baseline bone marrow assessment * For patients presenting with relapsed AML, \> 5% blasts on baseline bone marrow assessment Exclusion Criteria: * An initial diagnosis of acute promyelocytic leukemia (as defined by French-American-British criteria (Bennett 1976)) * Secondary AML, defined as AML evolving from antecedent hematological disorder or prior exposure to leukemogenic therapy or agent * Clinically active CNS leukemia * Previously received a total cumulative dose of cytarabine \> 6g/m2 in the last 6 months * Previously received \> 1 induction regimen (Defined as 1 or 2 cycles of a drug or a drug combination administered as remission induction therapy)
References
Publications (0)
Data not yet available
No reference posted for this study.