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NCT01379274 · ClinicalTrials.gov registry record · Phase 2
A Trial of Lenalidomide & Azacitidine in Low Risk Myelodysplastic Syndromes
A Phase 2 study, sponsored by Rush University Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT01379274: Clinical Trial Phase 2 study, sponsored by Rush University Medical Center.
NCT01379274 is a Phase 2 study that was terminated before completion, run by Rush University Medical Center. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01379274, a Phase 2 study, was terminated before completion, sponsored by Rush University Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
This phase II study will evaluate the safety and efficacy of combining two active agents;Revlimid® (lenalidomide) and low dose Vidaza® (azacitidine) for the treatment of patients with low to intermediate-1 MDS excluding patients with 5 q deletion. The rationale for adding Vidaza® (azacitidine) after 3 months of revlimid monotherapy is that combination therapy will result in higher response rates, and potentially longer response duration than that achieved with either agent. STUDY OBJECTIVES: Primary: To determine the safety and tolerability of the combination of Revlimid® (lenalidomide) and low dose Vidaza® (azacitidine) in patients with low - intermediate-1 risk MDS non 5 q deletion who have not responded after 3 months of Revlimid® (lenalidomide) monotherapy Secondary: To determine the response rate in patients with low - intermediate-1 risk MDS non 5 q deletion receiving Revlimid® (lenalidomide) in combination with low dose Vidaza® (azacitidine), as defined by the IWG 2006 Revised Response Criteria
Primary Outcome
To determine the number of subjects who develop grade 4 toxicity while on combination therapy.
Interventions
- DRUG Lenalidomide and azacitidine combination
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2011-01 |
| Est. Completion | 2013-11 |
| Phase | Phase 2 |
Why NCT01379274 stopped before completion
NCT01379274 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Lenalidomide and azacitidine combination is the first listed.
NCT01379274 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01379274 about?
NCT01379274 is a clinical study titled "A Trial of Lenalidomide & Azacitidine in Low Risk Myelodysplastic Syndromes". This phase II study will evaluate the safety and efficacy of combining two active agents;Revlimid® (lenalidomide) and low dose Vidaza® (azacitidine) for the treatment of patients with low to intermediate-1 MDS excluding patients with 5 q deletion. The rationale for adding Vidaza® (azacitidine) after...
What is the current status of trial NCT01379274?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2011-01. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01379274?
The interventions under investigation include: Lenalidomide and azacitidine combination (DRUG).
Who is sponsoring clinical trial NCT01379274?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01379274's enrollment target sits among peer trials
2 2001st of 2000 the lowest 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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