Bendamustine Versus Fludarabine as 2nd-line Treatment in Chronic Lymphocytic Leukemia, Stage BINET B+C / RAI II-IV
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- progression-free survival
Study Overview
Brief Summary
Bendamustine demonstrated clinical activity in pre-treated hematological malignancies due to its unique mechanism of action distinct from standard alkylating agents. This study assesses its efficacy in patients with chronic lymphocytic leukemia pre-treated with an alkylator, in comparison to fludarabine.
Patients with relapsed chronic lymphocytic leukemia requiring treatment after one previous systemic regimen (usually chlorambucil-based) are randomized to either receive bendamustine 100 mg/m² on days 1 and 2 of a 4-week cycle, or standard fludarabine treatment consisting of 25 mg/m² on days 1 to 5 every four weeks. The primary objective was to achieve non-inferior progression-free survival with bendamustine.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •histologically or immunologically confirmed chronic B-cell leukemia
- •refractory (i.e. no response or progression during initial chemotherapy) or relapsed situation after first-line treatment regimen
- •disease stage II-IV according to Rai or B/C according to Binet staging system, respectively
- •Eastern Cooperative Oncology Group (ECOG) performance status of 3 or better
- •negative pregnancy test/ adequate method of contraception
Exclusion Criteria
- •T-CLL, PLL (prolymphocytic leukemia)
- •presence of Richter's transformation
- •first-line treatment containing either fludarabine or bendamustine
- •acute infections or distinctly reduced organ function precluding the application of chemotherapy, as for pulmonary, heart, liver (total bilirubin > 5mg/dl), renal system (creatinine > 2 mg/dl), or metabolic disorders
- •secondary malignancy (except for curative treated basal cell carcinoma or cervical cancer)
Arms & Interventions
Bendamustine
Intervention: bendamustine (Drug)
Fludarabine
Intervention: Fludarabine (Drug)
Outcomes
Primary Outcomes
progression-free survival
Time Frame: the patients were followed on average for 36 months
individual time-frame up to max. follow-up (Kaplan-Meier estimation)
Secondary Outcomes
No secondary outcomes reported