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 |
| Protocol serial number | 02CLLIII |
| Sponsor | Mundipharma Research Ltd (UK) |
| Funder | Mundipharma Research Ltd (UK) |
- 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
Scientific
Gemeinschaftspraxis Oncology & Hematology
Krankenhaus Bethanien
Im Prüfling 17-19
Frankfurt
60389
Germany
| Phone | +49 (0)69 45 10 80 |
|---|---|
| wolfgang.knauf@telemed.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | 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 |
| Study objectives | 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(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Bendamustine hydrochloride, chlorambucil |
| Primary outcome measure(s) |
1. Overall response rate |
| Key secondary outcome measure(s) |
1. Time to progression |
| Completion date | 01/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 350 |
| Total final enrolment | 319 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2002 |
| Date of final enrolment | 01/06/2007 |
Locations
Countries of recruitment
- Germany
Study participating centre
Gemeinschaftspraxis Oncology & Hematology
Frankfurt
60389
Germany
60389
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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.
