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NCT01832922 · ClinicalTrials.gov registry record · Phase 1
BR in Patients With CLL With Comorbidities and/or Renal Dysfunction
A Phase 1 study, sponsored by Dartmouth-Hitchcock Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT01832922: Completed Phase 1 study, sponsored by Dartmouth-Hitchcock Medical Center.
NCT01832922 is a Phase 1 study that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01832922, a Phase 1 study, has completed, sponsored by Dartmouth-Hitchcock Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This is a non-randomized, open label, dose-ranging study of Bendamustine and Rituximab (BR) in patients with previously untreated or relapsed/refractory Chronic Lymphocytic Leukemia (CLL) who have multiple comorbidities with or without renal insufficiency. These agents are FDA approved for this indication. However, full dose bendamustine is associated with significant hematologic toxicity and a high rate of infectious complications in "unfit" patients and patients with significantly impaired renal function. This study will attempt to optimize and define adequate and safe treatment protocols for these patients with comorbidities and/or renal dysfunction. The study will accrue two independent patient cohorts which will follow a standard Phase I design. Patients with CLL who have significant comorbidities with or without minor renal dysfunction (CrCL\>40 mL/min) will be accrued onto Cohort 1 of the study. Patients with significant renal dysfunction (CrCL\<40 mL/min) will be accrued onto Cohort 2. Once the maximum tolerated dose (MTD) is determined, two expansion cohorts will be enrolled. There will be a treatment period of up to six 28-day cycles. On C1D1 all qualifying patients will provide samples for biomarker analysis. Six patients without renal dysfunction and 6 to 9 patients with renal dysfunction will also provide samples for bendamustine PK analysis. Accrual of both patient cohorts will occur simultaneously and will take place at two centers: Norris Cotton Cancer Center (NCCC) and Dana-Farber Cancer Institute (DFCI). Coordination of accrual to the study cohorts will be centralized at NCCC by Dr. Alexey V. Danilov.
Primary Outcome
To evaluate the safety (MTD) of bendamustine in combination with rituximab in patients with CLL who have multiple comorbidities and/or significant renal dysfunction.
Interventions
- DRUG Rituximab
- DRUG Bendamustine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2013-04 |
| Est. Completion | 2016-11-28 |
| Phase | Phase 1 |
What the finished NCT01832922 record still lists
NCT01832922 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Rituximab is the first listed.
NCT01832922 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01832922 about?
NCT01832922 is a clinical study titled "BR in Patients With CLL With Comorbidities and/or Renal Dysfunction". This is a non-randomized, open label, dose-ranging study of Bendamustine and Rituximab (BR) in patients with previously untreated or relapsed/refractory Chronic Lymphocytic Leukemia (CLL) who have multiple comorbidities with or without renal insufficiency. These agents are FDA approved for this indi...
What is the current status of trial NCT01832922?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2013-04. Estimated completion is 2016-11-28.
What interventions are being tested in trial NCT01832922?
The interventions under investigation include: Rituximab (DRUG), Bendamustine (DRUG).
Who is sponsoring clinical trial NCT01832922?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01832922's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 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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