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

Arbeitsgemeinschaft medikamentoese Tumortherapie

Status and phase: Completed; Phase 3

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

Treatments: Drug: Rituximab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00400478

NHL-13 (ML18223)

Details and patient eligibility

About

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.

Enrollment: 683 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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683 participants in 2 patient groups

A

Active Comparator group

Description:

Treatment

Treatment:

Drug: Rituximab

B

No Intervention group

Description:

Observation