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NCT01034592 · ClinicalTrials.gov registry record · Phase 1
Pilot Lenalidomide in Adult Diamond-Blackfan Anemia Patients w/ RBC Transfusion-Dependent Anemia
A Phase 1 study, sponsored by Jason Robert Gotlib.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT01034592: Clinical Trial Phase 1 study, sponsored by Jason Robert Gotlib.
NCT01034592 is a Phase 1 study that was terminated before completion, run by Jason Robert Gotlib. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01034592, a Phase 1 study, was terminated before completion, sponsored by Jason Robert Gotlib.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
This is a single-center, single arm, open-label study of oral lenalidomide monotherapy administered to red blood cell (RBC) transfusion dependent adult subjects with Diamond-Blackfan Anemia (DBA). Primary Objective: To evaluate the erythroid response rate as measured by rate of red blood cell transfusion independence \[MDS International Working Group (IWG) 2000 Criteria will be applied\]. Secondary Objective: 1)To evaluate the tolerability and safety profile of lenalidomide in patients with DBA and other inherited marrow failure syndromes 2) To correlate response to lenalidomide with biologic surrogates of DBA including ribosomal protein mutation status, ex vivo erythroid colony growth, and microarray gene expression
Primary Outcome
Red blood cell (RBC) transfusion independence is reported as the number of subjects who achieve a continuous absence of the intravenous infusion of any RBC transfusion during any consecutive "rolling" 56 days during the treatment period.
Interventions
- DRUG Lenalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2009-11 |
| Est. Completion | 2012-12 |
| Phase | Phase 1 |
Why NCT01034592 stopped before completion
NCT01034592 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Lenalidomide is the first listed.
NCT01034592 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01034592 about?
NCT01034592 is a clinical study titled "Pilot Lenalidomide in Adult Diamond-Blackfan Anemia Patients w/ RBC Transfusion-Dependent Anemia". This is a single-center, single arm, open-label study of oral lenalidomide monotherapy administered to red blood cell (RBC) transfusion dependent adult subjects with Diamond-Blackfan Anemia (DBA). Primary Objective: To evaluate the erythroid response rate as measured by rate of red blood cell trans...
What is the current status of trial NCT01034592?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2009-11. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01034592?
The interventions under investigation include: Lenalidomide (DRUG).
Who is sponsoring clinical trial NCT01034592?
This trial is sponsored by Jason Robert Gotlib, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01034592's enrollment target sits among peer trials
2 2000th of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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