Status:
COMPLETED
Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)
Lead Sponsor:
WiSP Wissenschaftlicher Service Pharma GmbH
Collaborating Sponsors:
Klinikum Leverkusen gGmbH
ribosepharm GmbH
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 i...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT01423032
Start Date
September 1 2001
End Date
May 1 2009
Last Update
August 25 2011
Active Locations (1)
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1
Prof. Dr. Norbert Niederle
Leverkusen, North Rhine-Westphalia, Germany, D-51375