Primary Rituximab and Maintenance

Sponsor
Lymphoma Study Association
Study ID
NCT00140582
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

* 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.

Key Dates

Start date
Dec 31, 2004
Status verified
Mar 2017
Primary completion
May 31, 2007
Completion
Dec 31, 2016

Study Design

Enrollment
1,217 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A : rituximab maintenance
    Maintenance with rituximab for 2 years
  • No Intervention: B : no maintenance
    No further treatment

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: number of event observed driven : 344 events or 10 years ]

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