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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 is a Phase 1 study that was terminated before completion, run by Jason Robert Gotlib. The registered enrollment target is 2 participants.
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
Interventions
- DRUG Lenalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2009-11 |
| Est. Completion | 2012-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01034592
The ClinicalTrials.gov registry entry for NCT01034592 describes a study currently listed as terminated, categorized as Phase 1. 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 Jason Robert Gotlib, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Lenalidomide is the first listed.
NCT01034592 reports 0 study locations.
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.
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