Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)

WiSP Wissenschaftlicher Service Pharma GmbH96 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Lymphocytic Leukemia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

progression-free survival

individual time-frame up to max. follow-up (Kaplan-Meier estimation)

Time frame: the patients were followed on average for 36 months