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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Arbeitsgemeinschaft medikamentoese Tumortherapie.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:
NCT00400478
First received: November 16, 2006
Last updated: January 19, 2009
Last verified: January 2009
  Purpose

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 Intervention Phase
Diffuse Large B-Cell Lymphoma (DLBCL)
Follicular NHL Grade 3b
Drug: Rituximab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:

Primary Outcome Measures:
  • event free survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • progression free survival, overall survival and safety [ Time Frame: four years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: January 2006
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Treatment
Drug: Rituximab
Rituximab 375mg/m2 i every 8 weeks for two years (12 infusions)
No Intervention: B
Observation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400478

  Show 131 Study Locations
Sponsors and Collaborators
Arbeitsgemeinschaft medikamentoese Tumortherapie
Hoffmann-La Roche
Investigators
Principal Investigator: Ulrich Jaeger, Prof. Dr. Medical University of Vienna
  More Information

No publications provided

Responsible Party: Prof. Ulrich Jäger, AGMT
ClinicalTrials.gov Identifier: NCT00400478     History of Changes
Other Study ID Numbers: NHL-13 (ML18223)
Study First Received: November 16, 2006
Last Updated: January 19, 2009
Health Authority: Austria: Ethikkommission

Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
DLBCL
NHL 13
Rituximab
maintenance

Additional relevant MeSH terms:
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
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 29, 2014