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| 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 |
| ClinicalTrials.gov identifier | |
| Public 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 |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | 02CLLIII |
| 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. |
| Lay summary | |
| Ethics approval | Not provided at time of registration. |
| Study design | Randomised controlled trial |
| Countries of recruitment | Germany |
| Disease/condition/study domain | B-Cell Lymphocytic Leukaemia (B-CLL) |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/11/2002 |
| Anticipated end date | 01/06/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 350 |
| Interventions |
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 |
| Primary outcome measure(s) |
1. Overall response rate
2. Progression-free survival |
| Secondary outcome measure(s) |
1. Time to progression
2. Duration of response 3. Overall survival 4. Infection rate 5. Quality of life 6. Toxicity |
| Sources of funding | Mundipharma Research Ltd (UK) |
| Trial website | |
| Publications | |
| Contact name | Prof Wolfgang Knauf |
| Address |
Gemeinschaftspraxis Oncology & Hematology
Krankenhaus Bethanien Im Prüfling 17-19 |
| City/town | Frankfurt |
| Zip/Postcode | 60389 |
| Country | Germany |
| Tel | +49 (0)69 45 10 80 |
| Fax | +49 (0)69 45 82 57 |
| wolfgang.knauf@telemed.de | |
| Sponsor | Mundipharma Research Ltd (UK) |
| Address |
Science Park
Milton Road Building 220 |
| City/town | Cambridge |
| Zip/Postcode | CB4 0GW |
| Country | United Kingdom |
| Tel | +44 (0)1223 424900 |
| thomas.mehrling@mundipharma.co.uk | |
| Date applied | 20/10/2005 |
| Last edited | 29/10/2007 |
| Date ISRCTN assigned | 23/11/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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