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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00400478

Enrollment

683

Registered

2006-11-17

Start date

2006-01-31

Completion date

2013-03-31

Last updated

2016-05-26

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

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL), Follicular NHL Grade 3b

Keywords

DLBCL, NHL 13, Rituximab, maintenance

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.

Interventions

DRUGRituximab

Rituximab 375mg/m2 i every 8 weeks for two years (12 infusions)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
event free survival	4 years

Secondary

Measure	Time frame
progression free survival, overall survival and safety	four years

Countries

Australia, Austria, Bosnia and Herzegovina, Brazil, Bulgaria, China, Croatia, Czechia, Estonia, Hong Kong, Israel, Latvia, Malaysia, Mexico, North Macedonia, Peru, Romania, Russia, Serbia, Slovakia, Slovenia, South Africa, Sweden, Taiwan, Thailand, Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026