Phase III, open-label, randomised, multicentre efficacy and safety study of bendamustine hydrochloride versus chlorambucil in treatment-naive patients with (Binet Stage B/C) chronic B-Cell Lymphocytic Leukaemia (B-CLL) requiring therapy

ISRCTN ISRCTN03739647
DOI https://doi.org/10.1186/ISRCTN03739647
Secondary identifying numbers 02CLLIII
Submission date
20/10/2005
Registration date
23/11/2005
Last edited
10/06/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Wolfgang Knauf
Scientific

Gemeinschaftspraxis Oncology & Hematology
Krankenhaus Bethanien
Im Prüfling 17-19
Frankfurt
60389
Germany

Phone +49 (0)69 45 10 80
Email wolfgang.knauf@telemed.de

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titlePhase III, open-label, randomised, multicentre efficacy and safety study of bendamustine hydrochloride versus chlorambucil in treatment-naive patients with (Binet Stage B/C) chronic B-Cell Lymphocytic Leukaemia (B-CLL) requiring therapy
Study objectivesThe proof of efficacy and tolerability of bendamustine in comparison to chlorambucil in the first line treatment of B-Cell Lymphocytic Leukaemia (B-CLL).

Please note that as of 29/10/2007 the funder and sponsor of this record were changed. The previous funder and sponsor was Ribosepharm GmbH (Germany). This change was made due to a change in the licensee of bendamustine: Ribosepharm GmbH was the licensee until April 31, 2007. After this date Mundipharma Research Ltd became the new licensee and took over the responsibility for the ongoing clinical trials with bendamustine.
Ethics approval(s)Not provided at time of registration.
Health condition(s) or problem(s) studiedB-Cell Lymphocytic Leukaemia (B-CLL)
InterventionArm A: Bendamustine 100 mg/m^2 days 1 + 2 repeated every 28 days
Arm B: Chlorambucil 0.8 mg/kg (Broca's normal weight) day 1 + day 15 every 28 days
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Bendamustine hydrochloride, chlorambucil
Primary outcome measure1. Overall response rate
2. Progression-free survival
Secondary outcome measures1. Time to progression
2. Duration of response
3. Overall survival
4. Infection rate
5. Quality of life
6. Toxicity
Overall study start date01/11/2002
Completion date01/06/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants350
Total final enrolment319
Key inclusion criteria1. Treatment-naive
2. Confirmed chronic B-cell lymphocytic leukemia
3. Symptomatic Binet stage B or Binet stage C disease
4. Written informed consent
5. World Health Organization (WHO) performance status 0 - 2
6. Life expectancy greater than 3 months
Key exclusion criteria1. Previous treatment with other cytotoxic drugs
2. Participation in another clinical trial within 4 weeks prior to or during this study
3. Mental disorders
4. History of a second malignancy
5. Manifest immune hemolysis or immune thrombocytopenia that can be treated with glucocorticoids alone
6. Richter's syndrome or transformation to Prolymphocytic Leukemia (PLL)
7. Abnormal liver, renal and cardiac function
8. Known Human Immunodeficiency Virus (HIV) infection
9. Major surgery within 30 days before the start of the trial
10. Pregnancy
11. Lactation
Date of first enrolment01/11/2002
Date of final enrolment01/06/2007

Locations

Countries of recruitment

  • Germany

Study participating centre

Gemeinschaftspraxis Oncology & Hematology
Frankfurt
60389
Germany

Sponsor information

Mundipharma Research Ltd (UK)
Industry

Science Park
Milton Road
Building 220
Cambridge
CB4 0GW
United Kingdom

Phone +44 (0)1223 424900
Email thomas.mehrling@mundipharma.co.uk
ROR logo "ROR" https://ror.org/025194b42

Funders

Funder type

Industry

Mundipharma Research Ltd (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 10/09/2009 10/06/2021 Yes No

Editorial Notes

10/06/2021: Publication reference and total final enrolment added.