A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation in Patients With Aggressive B-cell Lymphoma: NHL-13

Phase 3

Completed

• Conditions: Diffuse Large B-Cell Lymphoma (DLBCL); Follicular NHL Grade 3b
• Interventions: Drug: Rituximab

• Registration Number: NCT00400478
• Lead Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie

Brief Summary

This is a randomized, open label, phase III study to evaluate the ability of rituximab maintenance therapy to prolong event-free survival in aggressive NHL.

Patients will be screened after successful standard induction therapy (CR or Cru following standard R-CHOP-like therapy with 8 infusions of rituximab plus CHOP-like chemotherapy (4-8 cycles). Patients will be followed until an event occurs as defined in the protocol. To evaluate the clinical efficacy of rituximab maintenance therapy as compared to observation in patients with aggressive B-cell Non-Hodgkins lymphoma or follicular lymphoma grade 3b who have achieved a complete remission after appropriate first-line therapy, measured by event-free survival (EFS), 440 patients with DLCBL or follicular NHL grade 3 (220 per arm) will be recruited.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-11-16
• Study First Submitted QC: 2006-11-16
• Study First Posted: 2006-11-17
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-25
• Last Update Posted: 2016-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 683

Inclusion Criteria

• 4 to 8 cycles R-CHOP/like, total of 8x Rituximab
• CR, CRu
• ECOG/ 0.1 or 2
• Known IPI at time of diagnosis
• Age > 18 years
• Negative pregnancy test
• Men must agree not to father a child during the therapy

Exclusion Criteria

• Transformed lymphoma
• Secondary malignancy
• Evidence of CNS - involvement
• Significant cardiac disease
• Creatinine > 2.0 mg/dl
• HIV, Hepatitis positive

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Rituximab	Treatment

Primary Outcome Measures

Name	Time	Method
event free survival	4 years

Secondary Outcome Measures

Name	Time	Method
progression free survival, overall survival and safety	four years

Trial Locations

Locations (130)

Border Medical Oncology; 🇦🇺 Wodonga, Victoria, Australia

Concord Repatriation General Hospital; 🇦🇺 Concord, Australia

Gosford Hospital; 🇦🇺 Gosford, Australia

Greenslopes Hospital; 🇦🇺 Greenslopes, Australia

Prince of Wales Hospital; 🇦🇺 Sidney, Australia

Krankenhaus Oberpullendorf; 🇦🇹 Oberpullendorf, Burgenland, Austria

Krankenhaus Oberwart; 🇦🇹 Oberwart, Burgenland, Austria

A.ö. Krankenhaus der Landeshauptstadt St. Pölten; 🇦🇹 St. Poelten, Niederoesterreich, Austria

A.ö. Krankenhaus der Statutarstadt Wr. Neustadt; 🇦🇹 Wr. Neustadt, Niederoesterreich, Austria

Krankenhaus d. Barmherzigen Schwestern Linz; 🇦🇹 Linz, Oberoesterreich, Austria

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