Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)
NCT ID: NCT01423032
Last Updated: 2011-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
96 participants
INTERVENTIONAL
2001-09-30
2009-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bendamustine
bendamustine
100 mg/m² iv, day 1+2, q4w
Fludarabine
Fludarabine
25 mg/m² iv, days 1-5, q4w
Interventions
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bendamustine
100 mg/m² iv, day 1+2, q4w
Fludarabine
25 mg/m² iv, days 1-5, q4w
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Klinikum Leverkusen gGmbH
UNKNOWN
ribosepharm GmbH
UNKNOWN
Mundipharma Research GmbH & Co KG
INDUSTRY
WiSP Wissenschaftlicher Service Pharma GmbH
OTHER
Responsible Party
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Principal Investigators
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Norbert Niederle, Prof, MD
Role: STUDY_CHAIR
Med. Klinik III, Klinikum Leverkusen gGmbH, Germany
Locations
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Prof. Dr. Norbert Niederle
Leverkusen, North Rhine-Westphalia, Germany
Countries
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Other Identifiers
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WISP_RI05
Identifier Type: -
Identifier Source: org_study_id
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