Clinical trial · Interventional
Maintenance Therapy in Acute Myeloid Leukemia (AML) Patients
A Randomized Phase II Study of Lenalidomide Maintenance Therapy in AML Patients Aged > 60 Years in CR1 or Higher and < 60 Years in CR2 or Higher
NCT00957385CI-TRIAL-00018307completedPhase 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 purpose of this study is to determine if Revlimid will help maintain patients with acute myeloid leukemia in remission.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Revlimid | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- Arm A will receive Revlimid.
- interventionNames
- Drug: Revlimid
- type
- NO_INTERVENTION
- label
- B
- description
- Arm B will not receive Revlimid but an observational arm
Primary outcomes (1)
- measure
- To assess the feasibility and assess the effect on relapse free survival by giving Revlimid in the post complete remission maintenance setting
- timeFrame
- The 1st interim analysis will be done once all subjects have completed 12 cycles, and the 2nd interim analysis will be done once all subjects have completed treatment.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of Acute myeloid leukemia in remission. * Able to take aspirin 81mgs daily. Exclusion Criteria: * Pregnant or breast feeding females. * Known hypersensitivity to thalidomide. * Any prior use of lenalidomide.
References
Publications (0)
Data not yet available
No reference posted for this study.