Phase 2
Completed N=51
Fludarabine, Bendamustine, and Rituximab (FBR) for Relapsed Chronic Lymphocytic Leukemia (CLL)
Source: ClinicalTrials.gov NCT01096992 ↗Enrolled (actual)
51
Serious AEs
56.9%
Results posted
Sep 2019
Primary outcomePrimary: Maximum Tolerated Dose (MTD) of Bendamustine Combined With Fixed-Dose Fludarabine and Rituximab (FBR) — 30 mg/m^2
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) of Bendamustine Combined With Fixed-Dose Fludarabine and Rituximab (FBR) |
30 | — |
| SECONDARY Overall Response Rate of Bendamustine Combined With Fixed-Dose Fludarabine and Rituximab (FBR) |
5; 3; 5; 2; 17 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have a diagnosis of CLL/Small Lymphocytic Lymphoma (SLL) and be previously treated
- Patients must have an indication for treatment by 2008 IWCLL Criteria
- Age >/= 16 years
- Zubrod performance status / 60 mg daily or equivalent), or immunotherapy within 21 days prior to enrollment or concurrent with this trial
Data sourced from ClinicalTrials.gov (NCT01096992). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.