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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN74547745

Enrollment

174

Registered

2005-12-08

Start date

2002-06-24

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B-cell lymphoma Cancer Lymphoma

Interventions

Rituximab maintenance compared to observation

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Event-free survival	—

Secondary

Measure	Time frame
Overall survival, progression-free survival	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026