Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that was terminated before completion, run by Rush University Medical Center. The registered enrollment target is 2 participants.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01379274
The ClinicalTrials.gov registry entry for NCT01379274 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rush University Medical Center, which has 320 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Lenalidomide and azacitidine combination is the first listed.
NCT01379274 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.