Contact information
Type
Scientific
Primary contact
Prof Wolfgang Knauf
ORCID ID
Contact details
Gemeinschaftspraxis Oncology & Hematology
Krankenhaus Bethanien
Im Prüfling 17-19
Frankfurt
60389
Germany
+49 (0)69 45 10 80
wolfgang.knauf@telemed.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
02CLLIII
Study information
Scientific title
Acronym
Study hypothesis
The 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
Not provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
B-Cell Lymphocytic Leukaemia (B-CLL)
Intervention
Arm 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 type
Drug
Phase
Phase III
Drug names
Bendamustine hydrochloride, chlorambucil
Primary outcome measure
1. Overall response rate
2. Progression-free survival
Secondary outcome measures
1. Time to progression
2. Duration of response
3. Overall survival
4. Infection rate
5. Quality of life
6. Toxicity
Overall trial start date
01/11/2002
Overall trial end date
01/06/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
350
Participant exclusion criteria
1. 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
Recruitment start date
01/11/2002
Recruitment end date
01/06/2007
Locations
Countries of recruitment
Germany
Trial participating centre
Gemeinschaftspraxis Oncology & Hematology
Frankfurt
60389
Germany
Sponsor information
Organisation
Mundipharma Research Ltd (UK)
Sponsor details
Science Park
Milton Road
Building 220
Cambridge
CB4 0GW
United Kingdom
+44 (0)1223 424900
thomas.mehrling@mundipharma.co.uk
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Mundipharma Research Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list