Phase II randomised study of fludarabine/cyclophosphamide combination with or without rituximab in patients with untreated mantle cell lymphoma
- Conditions
- Cancer: untreated mantle cell lymphomaCancerMantle cell lymphoma
- Registration Number
- ISRCTN81133184
- Lead Sponsor
- niversity College London (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 151
1. Age 18 years or older
2. Proven mantle cell lymphoma
3. Previously untreated disease at any stage requiring therapy
4. No previous chemotherapy
5. Life expectancy of at least 3 months
6. Signed and dated informed consent
1. Known serological positivity for hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
2. Pregnant or breast feeding
3. Concomitant uncontrolled serious medical conditions
4. Severe renal or hepatic impairment not related to lymphoma
5. Known hypersensitivity to murine proteins
6. Previous malignancy in the last 5 years (except non-melanomatous skin tumours and carcinoma in situ of the cervix)
7. Psychological illness or condition that prevents adequate trial compliance
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method