Condition category
Cancer
Date applied
20/10/2005
Date assigned
23/11/2005
Last edited
29/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes