Phase 2 N=51 Treatment

Fludarabine, Bendamustine, and Rituximab (FBR) for Relapsed Chronic Lymphocytic Leukemia (CLL)

Leukemia

Bottom Line

View on ClinicalTrials.gov: NCT01096992 ↗

Enrolled (actual)

Serious AEs

56.9%

Results posted

Sep 2019

Primary outcome: Primary: Maximum Tolerated Dose (MTD) of Bendamustine Combined With Fixed-Dose Fludarabine and Rituximab (FBR) — 30 mg/m^2

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Bendamustine (Drug); Fludarabine (Drug); Rituximab (Drug)
Age: Pediatric, Adult, Older Adult · 16+ yrs
Sex: All
Sponsor: M.D. Anderson Cancer Center
Primary completion: Mar 2017

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	—

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.

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

View full record on ClinicalTrials.gov →

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.