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NCT01743859 · ClinicalTrials.gov registry record · Phase 2
Azacitidine and Lenalidomide for Relapsed and Refractory Patients With Acute Myeloid Leukemia
A Phase 2 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
NCT01743859: Completed Phase 2 study, sponsored by University of Colorado, Denver.
NCT01743859 is a Phase 2 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 37 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01743859, a Phase 2 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
Study Summary
The primary objective of this study is to determine the complete remission/complete remission with incomplete recovery of blood counts (CR/CRi) rate for relapsed and refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) patients.
Primary Outcome
Change in baseline to end of study. To be assessed by standard criteria based on bone marrow examination. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Interventions
- DRUG Azacitidine
- DRUG Lenalidomide
- OTHER Off Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2012-12-06 |
| Est. Completion | 2016-08-03 |
| Phase | Phase 2 |
What the finished NCT01743859 record still lists
NCT01743859 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 3 interventions - of which Azacitidine is the first listed.
NCT01743859 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01743859 about?
NCT01743859 is a clinical study titled "Azacitidine and Lenalidomide for Relapsed and Refractory Patients With Acute Myeloid Leukemia". The primary objective of this study is to determine the complete remission/complete remission with incomplete recovery of blood counts (CR/CRi) rate for relapsed and refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) patients.
What is the current status of trial NCT01743859?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2012-12-06. Estimated completion is 2016-08-03.
What interventions are being tested in trial NCT01743859?
The interventions under investigation include: Azacitidine (DRUG), Lenalidomide (DRUG), Off Therapy (OTHER).
Who is sponsoring clinical trial NCT01743859?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01743859's enrollment target sits among peer trials
37 1484th of 2000 higher than 505 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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