CD20-positive B-cell chronic lymphocytic leukemia
Conditions
Interventions
Trade Name: MabThera
Product Name: MabThera
Product Code: RO 045-2294
Pharmaceutical Form: Concentrate for solution for injection
INN or
Sponsors
F. Hoffmann-La Roche Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with CD20-positive B-cell CLL (NCI criteria) who are previously untreated 2. Patients with progressive Binet stage B, or C requiring therapy according to NCI criteria 3. Age = 18 years 4. Signed written informed consent 5. Life expectancy > 6 months 6. Eastern Co-operative Oncology Group (ECOG) performance status /= 50x109/L, unless due to involvement of bone marrow by CLL 9. Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with other malignancy within the last 2 years prior to study entry, except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis ductal carcinoma in situ of the breast treated with lumpectomy alone with curative intent. 2. Patients with known concomitant haematological malignancy; e.g. myelodysplastic syndromes. 3. Patients with reproductive potential not willing to use effective method of contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) 4. Patients who have received previous treatment for CLL 5. Patients with active bacterial, viral, or fungal infection requiring systemic therapy 6. Patients with a history of severe cardiac disease; e.g. New York Heart Association (NYHA) Functional Class III or IV heart failure [Appendix 3], myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, or unstable angina 7. Patients with significant autoimmune cytopenia as assessed by the physician (Coombs positive patients without clinical signs of autoimmune haemolytic anaemia are eligible for study entry) 8. Patients with severe chronic obstructive pulmonary disease (COPD) with hypoxemia 9. Patients with uncontrolled diabetes mellitus (defined as HbA1c >/= 10%) 10. Patients with uncontrolled hypertension (normally defined as blood pressure repeatedly >/= 140/90mmHg, but investigator discretion to be used) 11. Patients with transformation to aggressive B-cell malignancy (e.g. large B-cell lymphoma, Richter’s syndrome or polymorphocytic leukaemia (PLL)) 12. Patients who have received any investigational treatment, or participating in another clinical trial, within 30 days of study start 13. Patients with known Human Immunodeficiency Virus (HIV) infection, or active Hepatitis B (HBV) or Hepatitis C (HCV) infection. 14. Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins 15. Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent. 16. Hypersensitivity to chlorambucil or to any of the excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate that the combination of rituximab and chlorambucil is safe by examining the adverse event profile.; Secondary Objective: The secondary objectives of this study are to determine the following outcome measures: •Overall response rate (ORR), complete response rate (CR), partial response rate (PR) and nodular partial response (nPR) •Progression-free survival •Disease-free survival •Duration of response •Overall survival •Proportion of patients who achieved eradication of detectable minimal residual disease ; Primary end point(s): The primary objective is to demonstrate that the combination of rituximab and chlorambucil is safe. The following safety parameters will be monitored during the study: AEs, SAEs, laboratory tests and physical examination (weight, vital signs and cardiopulmonary examination) | — |
Countries
United Kingdom
Outcome results
None listed