B-Cell Lymphocytic Leukaemia (B-CLL) Cancer Leukaemia
Conditions
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
Sponsors
Mundipharma Research Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Overall response rate 2. Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to progression 2. Duration of response 3. Overall survival 4. Infection rate 5. Quality of life 6. Toxicity | — |
Countries
Germany
Outcome results
None listed