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NCT01754857 · ClinicalTrials.gov registry record · Phase 2
Bendamustine and Rituximab Induction Therapy and Maintenance Rituximab and Lenalidomide in Previously Untreated CLL/SLL
A Phase 2 study, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT01754857: Completed Phase 2 study, sponsored by University of Wisconsin, Madison.
NCT01754857 is a Phase 2 study that has completed, run by University of Wisconsin, Madison. 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
NCT01754857, a Phase 2 study, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
The investigators propose a treatment strategy where patients are treated with induction chemoimmunotherapy consisting of rituximab + bendamustine for 6 cycles, followed by initiation of maintenance rituximab and lenalidomide among patients achieving an objective response (i.e., at least stable disease with some tumor shrinkage) to induction therapy. The goal of maintenance therapy will be to capitalize on the cytoreduction following induction chemotherapy with a maintenance regimen that has also shown promising activity in CLL, in order to allow for improved PFS in this population.
Primary Outcome
The primary objective is progression-free survival (PFS). Tumor measurements and disease assessments will be performed at the time of screening, following cycles 3 and 6 of induction chemotherapy, every 4 cycles during the maintenance portion of treatment, and at the end of treatment (EOT). Subjects with clinical evidence of progression prior to a planned disease assessment will be evaluated at the time of clinically suspected progression. Follow-up visits for disease assessment will occur every
Interventions
- DRUG Rituximab
- DRUG Lenalidomide
- DRUG Bendamustine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2013-11-12 |
| Est. Completion | 2022-06-30 |
| Phase | Phase 2 |
What the finished NCT01754857 record still lists
NCT01754857 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 3 interventions - of which Rituximab is the first listed.
NCT01754857 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01754857 about?
NCT01754857 is a clinical study titled "Bendamustine and Rituximab Induction Therapy and Maintenance Rituximab and Lenalidomide in Previously Untreated CLL/SLL". The investigators propose a treatment strategy where patients are treated with induction chemoimmunotherapy consisting of rituximab + bendamustine for 6 cycles, followed by initiation of maintenance rituximab and lenalidomide among patients achieving an objective response (i.e., at least stable dise...
What is the current status of trial NCT01754857?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2013-11-12. Estimated completion is 2022-06-30.
What interventions are being tested in trial NCT01754857?
The interventions under investigation include: Rituximab (DRUG), Lenalidomide (DRUG), Bendamustine (DRUG).
Who is sponsoring clinical trial NCT01754857?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01754857'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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