An open-label study to characterize the safety and response rate of MabThera (Rituximab) plus chlorambucil in previously untreated patients with CD20-positive B-cell chronic lymphocytic leukemia. - not applicable
- Conditions
- CD20-positive B-cell chronic lymphocytic leukemia
- Registration Number
- EUCTR2007-000172-16-GB
- Lead Sponsor
- F. Hoffmann-La Roche Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
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 7. Absolute Neutrophil Count (ANC) = 1x109/L
8. Platelet count >/= 50x109/L, unless due to involvement of bone marrow by CLL
9. Total bilirubin 10. Alkaline phosphatase and transaminases 11. A negative serum pregnancy test up to one week prior to the first cycle of treatment must be available both for pre-menopausal women and for women who are
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method