Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Lymphocytic Leukemia

Intervention / Treatment
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* Drug: bendamustine
* Drug: Fludarabine


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bendamustine<br> | Drug: bendamustine<br>* 100 mg/m² iv, day 1+2, q4w<br>|
| Active Comparator: Fludarabine<br> | Drug: Fludarabine<br>* 25 mg/m² iv, days 1-5, q4w<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival | individual time-frame up to max. follow-up (Kaplan-Meier estimation) | the patients were followed on average for 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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relapsed