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NCT00675441 · ClinicalTrials.gov registry record · Phase 2
Lenalidomide (Revlimid®) as Second Line Therapy in Patients With Chronic Graft-Vs-Host Disease (GVHD)
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT00675441: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00675441 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00675441, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if Revlimid® (lenalidomide), along with standard-of-care steroid treatment you are already receiving, can help to control Chronic Graft-Versus-Host Disease (cGVHD). The safety of this study drug in combination with the steroids will also be studied. Primary Objectives: * To assess the response rate of chronic GVHD to Lenalidomide after failing steroids * To evaluate the safety and tolerability of Lenalidomide in patients with chronic GVHD Secondary Objectives: * To assess the steroid-sparing capacity of Lenalidomide (as proportion of patients able to discontinue steroids while receiving or following therapy with Lenalidomide) * To assess changes in QOL after treatment with Lenalidomide * To analyze survival at 6 and 12 months after initiation of Lenalidomide * To evaluate relapse of underlying malignancy as well as second malignancies at 6 and 12 months after initiation of Lenalidomide
Primary Outcome
Treatment responses defined as complete (CR) or partial organ response (PR) of chronic Graft-Versus-Host Disease (GVHD) to lenalidomide. Complete organ response (CR) indicates resolution of all reversible manifestations related to chronic GVHD in a specific organ. Partial organ response (PR) requires at least 50% improvement in scale used to measure disease manifestations related to chronic GVHD. Tools for response evaluation were skin assessment and functional assessment including minute walk a
Interventions
- DRUG Lenalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2008-04 |
| Est. Completion | 2011-08 |
| Phase | Phase 2 |
Why NCT00675441 stopped before completion
NCT00675441 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Lenalidomide is the first listed.
NCT00675441 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00675441 about?
NCT00675441 is a clinical study titled "Lenalidomide (Revlimid®) as Second Line Therapy in Patients With Chronic Graft-Vs-Host Disease (GVHD)". The goal of this clinical research study is to learn if Revlimid® (lenalidomide), along with standard-of-care steroid treatment you are already receiving, can help to control Chronic Graft-Versus-Host Disease (cGVHD). The safety of this study drug in combination with the steroids will also be studie...
What is the current status of trial NCT00675441?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2008-04. Estimated completion is 2011-08.
What interventions are being tested in trial NCT00675441?
The interventions under investigation include: Lenalidomide (DRUG).
Who is sponsoring clinical trial NCT00675441?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00675441's enrollment target sits among peer trials
5 2000th 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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