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NCT01096992 · ClinicalTrials.gov registry record · Phase 1
Fludarabine, Bendamustine, and Rituximab (FBR) for Relapsed Chronic Lymphocytic Leukemia (CLL)
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT01096992: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01096992 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 51 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01096992, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of bendamustine, combined with fludarabine and rituximab, that can be given to patients who have CLL that has been treated before. The goal of Phase 2 of this study is to find out if this drug combination can help to control the disease. The safety of this drug combination will also be studied.
Primary Outcome
MTD defined as highest dose level in which 6 participants have been treated with \</= to 1 patient experiencing dose limiting toxicity (DLT). MTD exceeded if 2 or more of 6 patients experience grade 3 or higher, non-hematologic, non-infusion related toxicity a major organ system. DLT defined as treatment-related, grade \>/= 3 non-hematologic toxicity. Hematologic toxicity grade \>/= 3 that lasts longer than 42 days considered a DLT. Hematologic toxicity graded according to the 2008 IWCLL criteri
Interventions
- DRUG Fludarabine
- DRUG Rituximab
- DRUG Bendamustine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2010-04-19 |
| Est. Completion | 2017-03-31 |
| Phase | Phase 1 |
What the finished NCT01096992 record still lists
NCT01096992 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 3 interventions - of which Fludarabine is the first listed.
NCT01096992 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01096992 about?
NCT01096992 is a clinical study titled "Fludarabine, Bendamustine, and Rituximab (FBR) for Relapsed Chronic Lymphocytic Leukemia (CLL)". The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of bendamustine, combined with fludarabine and rituximab, that can be given to patients who have CLL that has been treated before. The goal of Phase 2 of this study is to find out if this drug combination can ...
What is the current status of trial NCT01096992?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2010-04-19. Estimated completion is 2017-03-31.
What interventions are being tested in trial NCT01096992?
The interventions under investigation include: Fludarabine (DRUG), Rituximab (DRUG), Bendamustine (DRUG).
Who is sponsoring clinical trial NCT01096992?
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 NCT01096992's enrollment target sits among peer trials
51 969th of 2000 higher than 1,028 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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