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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00400478
Recruitment Status : Completed
First Posted : November 17, 2006
Last Update Posted : May 26, 2016
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Arbeitsgemeinschaft medikamentoese Tumortherapie

Study Description
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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.


Condition or disease Intervention/treatment Phase
Diffuse Large B-Cell Lymphoma (DLBCL) Follicular NHL Grade 3b Drug: Rituximab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 683 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation Alone in Patients With Aggressive B-cell Lymphoma: NHL-13
Study Start Date : January 2006
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: A
Treatment
 Drug: Rituximab
Rituximab 375mg/m2 i every 8 weeks for two years (12 infusions)
No Intervention: B
Observation


Outcome Measures
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Primary Outcome Measures :
  1. event free survival [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. progression free survival, overall survival and safety [ Time Frame: four years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00400478


Locations
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Sponsors and Collaborators
Arbeitsgemeinschaft medikamentoese Tumortherapie
Hoffmann-La Roche
Investigators
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Principal Investigator: Ulrich Jaeger, Prof. Dr. Medical University of Vienna
More Information
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Additional Information:
AGMT  This link exits the ClinicalTrials.gov site

Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site

Publications of Results:

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Responsible Party: Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier: NCT00400478    
Other Study ID Numbers: NHL-13 (ML18223)
First Posted: November 17, 2006    Key Record Dates
Last Update Posted: May 26, 2016
Last Verified: May 2016
Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
DLBCL
NHL 13
Rituximab
maintenance
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents