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NCT01246076 · ClinicalTrials.gov registry record · Phase 2
Lenalidomide for Myelodysplastic Syndrome Refractory to Hypomethylating Agents
A Phase 2 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT01246076: Completed Phase 2 study, sponsored by Washington University School of Medicine.
NCT01246076 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01246076, a Phase 2 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the proportion of confirmed responses (complete response, partial response, and hematologic improvement as defined by revised IWG criteria during the 12 months of treatment.
Primary Outcome
* Complete remission (CR): ≤5% myeloblasts bone marrow blasts, normal maturation in all cell lines (dysplasia will be noted), ≥11 g/dl peripheral blood hemoglobin, ≥100x10\^9cells/μL peripheral blood platelets, ≥1000 cells/ μL peripheral blood absolute neutrophil count (ANC), and 0% peripheral blood blasts. * Marrow complete remission (MCR): ≤5% myeloblasts and decreased by ≥50% compared to pre-treatment bone marrow blasts, bone marrow morphology not relevant, and peripheral blood (if hematologi
Interventions
- DRUG Lenalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2011-06 |
| Est. Completion | 2015-08 |
| Phase | Phase 2 |
What the finished NCT01246076 record still lists
NCT01246076 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which Lenalidomide is the first listed.
NCT01246076 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01246076 about?
NCT01246076 is a clinical study titled "Lenalidomide for Myelodysplastic Syndrome Refractory to Hypomethylating Agents". The purpose of this study is to determine the proportion of confirmed responses (complete response, partial response, and hematologic improvement as defined by revised IWG criteria during the 12 months of treatment.
What is the current status of trial NCT01246076?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2011-06. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01246076?
The interventions under investigation include: Lenalidomide (DRUG).
Who is sponsoring clinical trial NCT01246076?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01246076's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 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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