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NCT01400685 · ClinicalTrials.gov registry record · Phase 1
Lenalidomide Plus Bendamustine and Rituximab for Untreated CLL/SLL
A Phase 1 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT01400685: Completed Phase 1 study, sponsored by Massachusetts General Hospital.
NCT01400685 is a Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01400685, a Phase 1 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
Lenalidomide belongs to a group of drugs called immunomodulatory drugs (IMiD) that can modify or regulate the functioning of the immune system. It is an FDA approved drug for people with multiple myeloma. It is not currently approved for use in Chronic Lymphocytic Leukemia (CLL), but it does appear effective in CLL when used alone, and is being studied for use in combination with chemotherapy in this and other lymphomas and leukemias. In this research study we are hoping to learn more about the effects of lenalidomide on CLL when given in combination with bendamustine and rituximab, which is a highly effective regimen for initial therapy of CLL/SLL. The investigators will be looking for the highest dose of lenalidomide that can be given safely, without causing any serious or unmanageable side effects.
Interventions
- DRUG Rituximab
- DRUG Lenalidomide
- DRUG Bendamustine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2012-12 |
| Est. Completion | 2018-01 |
| Phase | Phase 1 |
What the finished NCT01400685 record still lists
NCT01400685 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 3 interventions - of which Rituximab is the first listed.
NCT01400685 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01400685 about?
NCT01400685 is a clinical study titled "Lenalidomide Plus Bendamustine and Rituximab for Untreated CLL/SLL". Lenalidomide belongs to a group of drugs called immunomodulatory drugs (IMiD) that can modify or regulate the functioning of the immune system. It is an FDA approved drug for people with multiple myeloma. It is not currently approved for use in Chronic Lymphocytic Leukemia (CLL), but it does appear ...
What is the current status of trial NCT01400685?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2012-12. Estimated completion is 2018-01.
What interventions are being tested in trial NCT01400685?
The interventions under investigation include: Rituximab (DRUG), Lenalidomide (DRUG), Bendamustine (DRUG).
Who is sponsoring clinical trial NCT01400685?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01400685's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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