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NCT00655668 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study of Single-Agent Lenalidomide in Subjects With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma
A Phase 2 study, sponsored by Celgene.
- Terminated
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
NCT00655668 is a Phase 2 study that was terminated before completion, run by Celgene. The registered enrollment target is 54 participants.
The verdict
NCT00655668, a Phase 2 study, was terminated before completion, sponsored by Celgene.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
Study Summary
This is a Phase II, multicenter, single-arm, open-label study of oral lenalidomide monotherapy administered to subjects with relapsed or refractory T-cell lymphoma. This study will be conducted in two phases: a Treatment Phase and a Follow-up Phase. Subjects who qualify for enrollment into the study will enter the Treatment Phase and receive single-agent lenalidomide 25 mg once daily on Days 1-21 every 28 days (28-day cycles). Subjects may continue participation in the Treatment Phase of the study for a maximum duration of 24 months, or until disease progression or unacceptable adverse events develop. All subjects who discontinue the Treatment Phase for any reason will continue to be followed until progression of disease or until next lymphoma treatment is given, whichever comes first, during the Follow-up Phase. Objectives: Primary: • To determine the efficacy of lenalidomide monotherapy in relapsed or refractory T-cell Non-Hodgkin's Lymphoma (NHL). Efficacy will be assessed by measuring the response rate, tumor control rate, duration of response, time to progression and progression free survival. Secondary: • To evaluate the safety of lenalidomide monotherapy as treatment for subjects with relapsed or refractory T-cell NHL.
Interventions
- DRUG Lenalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2008-03-01 |
| Est. Completion | 2010-04-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00655668
The ClinicalTrials.gov registry entry for NCT00655668 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Lenalidomide is the first listed.
NCT00655668 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00655668 about?
NCT00655668 is a clinical study titled "A Phase II Study of Single-Agent Lenalidomide in Subjects With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma". This is a Phase II, multicenter, single-arm, open-label study of oral lenalidomide monotherapy administered to subjects with relapsed or refractory T-cell lymphoma. This study will be conducted in two phases: a Treatment Phase and a Follow-up Phase. Subjects who qualify for enrollment into the stud...
What is the current status of trial NCT00655668?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2008-03-01. Estimated completion is 2010-04-01.
What interventions are being tested in trial NCT00655668?
The interventions under investigation include: Lenalidomide (DRUG).
Who is sponsoring clinical trial NCT00655668?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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