Back to resultsBendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)
Primary Purpose
Chronic Lymphocytic Leukemia
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
bendamustine
Fludarabine
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring relapsed
Eligibility Criteria
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)
Sites / Locations
- Prof. Dr. Norbert Niederle
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bendamustine
Fludarabine
Arm Description
Outcomes
Primary Outcome Measures
progression-free survival
individual time-frame up to max. follow-up (Kaplan-Meier estimation)
Secondary Outcome Measures
Full Information
NCT ID
NCT01423032
First Posted
August 19, 2011
Last Updated
August 24, 2011
Sponsor
WiSP Wissenschaftlicher Service Pharma GmbH
Collaborators
Klinikum Leverkusen gGmbH, ribosepharm GmbH, Mundipharma Research GmbH & Co KG
1. Study Identification
Unique Protocol Identification Number
NCT01423032
Brief Title
Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)
Official Title
Bendamustine Versus Fludarabine as 2nd-line Treatment in Chronic Lymphocytic Leukemia, Stage BINET B+C / RAI II-IV
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
WiSP Wissenschaftlicher Service Pharma GmbH
Collaborators
Klinikum Leverkusen gGmbH, ribosepharm GmbH, Mundipharma Research GmbH & Co KG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia
Keywords
relapsed
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bendamustine
Arm Type
Experimental
Arm Title
Fludarabine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
bendamustine
Intervention Description
100 mg/m² iv, day 1+2, q4w
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
25 mg/m² iv, days 1-5, q4w
Primary Outcome Measure Information:
Title
progression-free survival
Description
individual time-frame up to max. follow-up (Kaplan-Meier estimation)
Time Frame
the patients were followed on average for 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norbert Niederle, Prof, MD
Organizational Affiliation
Med. Klinik III, Klinikum Leverkusen gGmbH, Germany
Official's Role
Study Chair
Facility Information:
Facility Name
Prof. Dr. Norbert Niederle
City
Leverkusen
State/Province
NRW
ZIP/Postal Code
D-51375
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)
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