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NCT01002755 · ClinicalTrials.gov registry record · Phase 2
Lenalidomide and Ofatumumab in Treating Participants With Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT01002755: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT01002755 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01002755, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
This phase II trial studies how well lenalidomide and ofatumumab work in treating participants with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as ofatumumab, may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and ofatumumab may work better in treating participants with chronic lymphocytic leukemia or small lymphocytic lymphoma
Primary Outcome
A Simon's two-stage minmax design will be used. Includes complete remission (CR) and partial remission (PR). Complete Response Requires the absence of disease signs and symptoms, and normalization of Peripheral blood and bone marrow. Partial Response it at lease a 50% reduction in disease signs and symptoms and normalization of peripheral blood.
Interventions
- DRUG Lenalidomide
- BIOLOGICAL Ofatumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2010-01-19 |
| Est. Completion | 2018-01-31 |
| Phase | Phase 2 |
What the finished NCT01002755 record still lists
NCT01002755 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Lenalidomide is the first listed.
NCT01002755 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01002755 about?
NCT01002755 is a clinical study titled "Lenalidomide and Ofatumumab in Treating Participants With Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma". This phase II trial studies how well lenalidomide and ofatumumab work in treating participants with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of tumor cells, either by kil...
What is the current status of trial NCT01002755?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2010-01-19. Estimated completion is 2018-01-31.
What interventions are being tested in trial NCT01002755?
The interventions under investigation include: Lenalidomide (DRUG), Ofatumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01002755?
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 NCT01002755's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 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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