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Primary Rituximab and Maintenance

NCT00140582 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1217

Last updated 2017-03-13

No results posted yet for this study

Summary

* Objectives

* Primary objective: To evaluate in patients with advanced follicular lymphoma the benefit of maintenance therapy with rituximab after induction of response with chemotherapy plus rituximab in comparison with no maintenance therapy
* Secondary objective: To evaluate response rates, event driven survival endpoints (EFS, PFS, OS) and quality of life of four different chemotherapy regimens combined with rituximab, with or without maintenance with rituximab, for first line treatment of advanced stage follicular lymphoma.
* Study Design This is an international open-label, multicentre, randomized study with two treatment phases. In the induction phase patients have to respond to 1st line induction treatment in order to be eligible for randomization to the second phase of maintenance treatment or observation. After the maintenance period patients will be included in the follow up phase for 3 years.

Conditions

Interventions

DRUG

Rituximab

rituximab 375 mg/m2 every 8 weeks for 24 months (12 injections) or control with no treatment

Sponsors & Collaborators

  • HOVON - Dutch Haemato-Oncology Association

    collaborator OTHER

  • German Low Grade Lymphoma Study Group

    collaborator OTHER

  • Australasian Leukaemia and Lymphoma Group

    collaborator OTHER

  • Institute of Cancer Research, United Kingdom

    collaborator OTHER

  • Lymphoma Study Association

    lead OTHER

Principal Investigators

  • Gilles A Salles, MD PhD · Lymphoma Study Association

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2007-05-31
Completion
2016-12-31

Countries

  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Colombia
  • Denmark
  • France
  • Netherlands
  • New Zealand
  • Peru
  • Spain
  • Thailand

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00140582 on ClinicalTrials.gov