Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: WiSP Wissenschaftlicher Service Pharma GmbH
• Collaborators: Klinikum Leverkusen gGmbH; Mundipharma Research GmbH & Co KG; ribosepharm GmbH
• Treatments: Bendamustine Hydrochloride; Fludarabine; Fludarabine phosphate; Vidarabine

Criteria

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)