NCT01423032

Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)

Bendamustine Versus Fludarabine as 2nd-line Treatment in Chronic Lymphocytic Leukemia, Stage BINET B+C / RAI II-IV

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: WiSP Wissenschaftlicher Service Pharma GmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	bendamustine	100 mg/m² iv, day 1+2, q4w
DRUG	Fludarabine	25 mg/m² iv, days 1-5, q4w

Timeline

• Start date: 2001-09-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2011-08-25
• Last updated: 2011-08-25

Locations

1 site across 1 country: Germany