Standard chemotherapy combination (Cyclophosphamide, Hydroxydaunorubicin, Vincristine, Prednisolone [CHOP]) with 1, 3 or 6 cycles of the monoclonal anti-CD20-antibody. Rituximab in first line therapy of follicular non-Hodgkin?s lymphoma.
- Conditions
- Follicular Lymphoma World Health Organisation (WHO) Grade I and II, Stage 3-4LymphomaCancer
- Registration Number
- ISRCTN47525145
- Lead Sponsor
- niversity of Heidelberg (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
1. Patients with histologically proven CD20+ follicular lymphoma (follicular lymphoma grade I, II), stage III and IV
2. Age >18 years, no upper limit
3. No pre-treatment except irradiation and/or corticosteroids
4. Requirement of therapy: one or more of the following: B-symptoms, hematopoietic insufficiency (leukopenia <1.5/nl, anemia hb <10 g/dl, platelets <100/nl)
5. Objective tumor progression (>50% increase in sum of tumor diameters in six months); 'bulky disease' (mediastinal/abdominal tumor >7.5 cm and/or other lymphnodes >5 cm)
1. Age <18 years
2. Stage I or II
3. CD20 negativity
4. Karnofsky Index <80% or Eastern Cooperative Oncology Group (ECOG) >2
5. Pre-treatment with murine antibodies, severe organ impairment (heart, lung, neck) according to common criteria
6. Pre-treatment with any chemotherapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Molecular remission rate after the end of six cycles of CHOP with various cycles of Rituximab antibodies, determined by t(14;18) real time PCR in peripheral blood and bone marrow.
- Secondary Outcome Measures
Name Time Method 1. Clinical remission rate<br>2. Duration of molecular and clinical response<br>3. Toxicity