Randomized Phase III trial: Maintenance therapy with the monoclonal chimeric antibody rituximab compared to observation in patients with CD20+ B-cell Non-Hodgkins lymphoma

Phase 3

Completed

• Conditions: B-cell lymphoma; Cancer; Lymphoma

• Registration Number: ISRCTN74547745
• Lead Sponsor: niversity of Heidelberg (Germany) and Roche (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-08
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

1. B-cell CD20+ Non-Hodgkins Lymphoma (primary therapy and relapse). At study entry patients with agressive lymphoma need to have a complete remission, if a residual tumor is still present a positron-emission-tomography examination needs to reveal no active tumor. Patients with indolent lymphoma need at least a partial remission to enter this trial
2. Age above 18 years
3. Karnofsky Index above 60
4. Contraception and negative pregnancy test of women in reproducitve age
5. Valid patient approval

Exclusion Criteria

1. Manifest cardiac insufficiency
2. Chronic obstructive lung disease with hypoximia
3. Uncontrolled hypertension
4. Renal insufficiency (creatinine above 2 mg/dl)
5. Hepatic insufficiency (Bilirubin above 2.0 mg/dl)
6. Pregnancy
7. Breast feeding
8. Severe psychiatric illness
9. Human immunodeficiency virus (HIV) positive patients
10. Primary cerebral lymphoma
11. Previous allogeneic transplant

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Event-free survival

Secondary Outcome Measures

Name	Time	Method
Overall survival, progression-free survival