Spots Global Cancer Trial Database for Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)
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Trial Identification
Brief Title: Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)
Official Title: Bendamustine Versus Fludarabine as 2nd-line Treatment in Chronic Lymphocytic Leukemia, Stage BINET B+C / RAI II-IV
Study ID: NCT01423032
Conditions
Study Description
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:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Prof. Dr. Norbert Niederle, Leverkusen, NRW, Germany
Contact Details
Name: Norbert Niederle, Prof, MD
Affiliation: Med. Klinik III, Klinikum Leverkusen gGmbH, Germany
Role: STUDY_CHAIR
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