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
- Conditions
- B-Cell Lymphocytic Leukaemia (B-CLL)CancerLeukaemia
- Registration Number
- ISRCTN03739647
- Lead Sponsor
- Mundipharma Research Ltd (UK)
- Brief Summary
2009 results in https://pubmed.ncbi.nlm.nih.gov/19652068/ (added 10/06/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 319
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Overall response rate<br> 2. Progression-free survival<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Time to progression<br> 2. Duration of response<br> 3. Overall survival<br> 4. Infection rate<br> 5. Quality of life<br> 6. Toxicity<br>