Mantel Cell Lymphoma Efficacy of Rituximab Maintenance

Sponsor
French Innovative Leukemia Organisation
Study ID
NCT00921414
Phase
PHASE3
Status
Completed

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    2 months after ASCT maintenance treatment with Rituximab 500mg/m² IV every 2 months during 3 years
  • Watch and wait — OTHER
    No treatment patient follow-up every 2 months during 3 years

Study Details

Randomized, open-label, phase III study to evaluate the efficacy of rituximab maintenance therapy in patients aged between 18 and 65 years inclusive undergoing first-line treatment for mantle cell lymphoma and exhibiting a response after autologous transplantation.

Key Dates

Start date
Sep 30, 2008
Status verified
Apr 2018
Primary completion
Sep 30, 2008
Completion
Feb 28, 2017

Study Design

Enrollment
299 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 1
    observation : 3 years maintenance period with assesments and surveillance every 2 months
  • Experimental: 2
    maintenance period infusions of Rituximab 375 mg/m2/2 months and assessement and surveillance

Primary Outcome Measure

event-free survival (EFS) post Rituximab maintenance therapy [ Time Frame: EFS post 4 years after maintenance ]

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