Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)
1 other identifier
interventional
96
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2001
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 19, 2011
CompletedFirst Posted
Study publicly available on registry
August 25, 2011
CompletedAugust 25, 2011
August 1, 2011
7.7 years
August 19, 2011
August 24, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
progression-free survival
individual time-frame up to max. follow-up (Kaplan-Meier estimation)
the patients were followed on average for 36 months
Study Arms (2)
Bendamustine
EXPERIMENTALFludarabine
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- WiSP Wissenschaftlicher Service Pharma GmbHlead
- Klinikum Leverkusen gGmbHcollaborator
- ribosepharm GmbHcollaborator
- Mundipharma Research GmbH & Co KGcollaborator
Study Sites (1)
Prof. Dr. Norbert Niederle
Leverkusen, North Rhine-Westphalia, D-51375, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Norbert Niederle, Prof, MD
Med. Klinik III, Klinikum Leverkusen gGmbH, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2011
First Posted
August 25, 2011
Study Start
September 1, 2001
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
August 25, 2011
Record last verified: 2011-08