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NCT Number: NCT00400478

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

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.

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Key information

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL) Follicular NHL Grade 3b Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Border Medical Oncology, Wodonga, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rituximab

Drug

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

Primary outcomes

  1. event free survival

    Time frame: 4 years

Secondary outcomes

  1. progression free survival, overall survival and safety

    Time frame: four years

Sponsors and collaborators

Lead sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Other

Collaborators

  • Hoffmann-La Roche

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Nov 17, 2006
Registry last updated
May 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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