NCT00921414

Mantel Cell Lymphoma Efficacy of Rituximab Maintenance

Manteau 2007 SJ "LYMA" "Randomized, Open-label, Phase III Study Efficacy of Rituximab Maintenance Therapy in Patients 18 to 65 Years , First-line Treatment for MCL

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 299 (actual)
• Sponsor: French Innovative Leukemia Organisation · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Demonstration of the superiority in terms of 4-year event-free survival (EFS) of Rituximab maintenance therapy compared to post-autograft surveillance in patients aged 18-65 years inclusive, treated with R-DHAP then autologous transplantation for MCL as first-line therapy.

Conditions

• Mantle Cell Lymphoma

Interventions

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

Timeline

• Start date: 2008-09-01
• Primary completion: 2008-09-01
• Completion: 2017-02-01
• First posted: 2009-06-16
• Last updated: 2018-04-27

Locations

1 site across 1 country: France