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NCT00963105 · ClinicalTrials.gov registry record · Phase 2
Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
A Phase 2 study of Relapsed or Refractory Chronic Lymphocytic Leukemia, sponsored by Celgene.
- Completed
- Registry status
- Phase 2
- Development phase
- 104
- Enrollment target
- 20
- Study locations
NCT00963105: Completed Phase 2 study of Relapsed or Refractory Chronic Lymphocytic Leukemia, sponsored by Celgene.
NCT00963105 is a Phase 2 study of Relapsed or Refractory Chronic Lymphocytic Leukemia that has completed, run by Celgene. The registered enrollment target is 104 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00963105, a Phase 2 study of Relapsed or Refractory Chronic Lymphocytic Leukemia, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 104 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine the safety and effectiveness of different dose regimens of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia (CLL).
Primary Outcome
Adverse events (AEs) were graded for severity by the investigator according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 with the exceptions of hematologic toxicities and tumor lysis syndrome, according to the following scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening or disabling AE Grade 5 = Death The investigator determined the relationship of each AE to study drug based on the timing of the AE and
Conditions Studied
Interventions
- DRUG lenalidomide
Study Locations (20)
California
- UCSD Moores Cancer Center - La Jolla
- Desert Hematology Oncology Medical Group, Inc. - Rancho Mirage
- Stanford University School of Medicine - Stanford
Illinois
- Northwestern University Medical Center Division of Hematology Oncology - Chicago
- Rush University Medical Center - Chicago
New York
- Roswell Park Cancer Institute - Buffalo
- Long Island Jewish Medical Center CLL Research and Treatment Program - New Hyde Park
Ohio
- Gabrail Cancer Center Research - Canton
- Cleveland Clinic Foundation - Cleveland
Other
- CHU Sud - Amiens
- Hopital Avicenne - Bobigny
Connecticut
- Cancer Center of Central Connecticut - Southington
Florida
- Cancer and Blood Disease Center - Lecanto
Indiana
- Indiana University Cancer Center - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2009-10-19 |
| Est. Completion | 2017-09-05 |
| Phase | Phase 2 |
What the finished NCT00963105 record still lists
NCT00963105 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower).
The record links to 1 condition, with Relapsed or Refractory Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which lenalidomide is the first listed.
NCT00963105 names 20 study sites across 14 states, led by California, Illinois, New York.
Frequently Asked Questions
What is clinical trial NCT00963105 about?
NCT00963105 is a clinical study titled "Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia". The purpose of this study is to determine the safety and effectiveness of different dose regimens of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia (CLL).
What is the current status of trial NCT00963105?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2009-10-19. Estimated completion is 2017-09-05.
What conditions does trial NCT00963105 study?
This clinical trial studies the following conditions: Relapsed or Refractory Chronic Lymphocytic Leukemia.
What interventions are being tested in trial NCT00963105?
The interventions under investigation include: lenalidomide (DRUG).
Who is sponsoring clinical trial NCT00963105?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00963105 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00963105's enrollment target sits among peer trials
104 660th of 2000 higher than 1,337 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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