Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- Registration Number
- NCT01423032
- Lead Sponsor
- WiSP Wissenschaftlicher Service Pharma GmbH
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bendamustine bendamustine - Fludarabine Fludarabine -
- Primary Outcome Measures
Name Time Method progression-free survival the patients were followed on average for 36 months individual time-frame up to max. follow-up (Kaplan-Meier estimation)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Prof. Dr. Norbert Niederle
🇩🇪Leverkusen, NRW, Germany