Chimeric anti-CD20 monoclonal antibody (Mabthera) in remission induction and maintenance treatment of relapsed follicular non-Hodgkin's lymphoma (NHL): a phase III randomised clinical trial (Intergroup Collaborative Study)

Not Applicable

Completed

• Conditions: ymphoma (non-Hodgkin's); Cancer; Lymphoma (non-Hodgkin's)

• Registration Number: ISRCTN65655917
• Lead Sponsor: European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)

Brief Summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20368567

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2002-08-19
• Study Completion: 2005-11-11
• Last Update Posted: 19 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 465

Inclusion Criteria

1. Patients with Ann Arbour stages III or IV follicular NHL (at initial diagnosis) who have relapsed after a minimum of two adequate non-anthracycline containing systemic chemotherapy regimens. Patients pre-treated with other chemotherapy regimens are not eligible for this trial.
2. Patients should have achieved remission on at least one of the prior regimens (i.e. either on the first or second regimen)
3. Remission duration upon one of the prior regimens should have been at least 3 months
4. Previous treatment should have been at least 4 month of single agent therapy (e.g. chlorambucil) and/or at least four consecutive cycles of polychemotherapy (e.g. CVP) or purine analogues. Patients treated with chemotherapy not fulfilling these criteria are not eligible.
5. Follicular NHL according to the Revised European/American Lymphoma (REAL) classification, i.e. follicle centre lymphoma, follicular (provisional cytological grades I [small cell], II [mixed small cell and large cell], III [large cell])
6. Must be CD20 positive lymphoma
7. At least one mass should be present measurable by two perpendicular diameters by either physical or radiological examination
8. Aged 18 years or above
9. World Health Organization (WHO) performance status 0, 1 or 2
10. Patient information and written informed consent according to the rules of the respective country

Exclusion Criteria

Does not match inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ot provided at time of registration<br>

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration