Mantel Cell Lymphoma Efficacy of Rituximab Maintenance

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French Innovative Leukemia Organisation
• Collaborator: Lymphoma Study Association
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• mantle cell lymphoma

• Initial immunophenotyping with CD20 and CD5.

• CD20+.

• t (11;14) by karyote, FISH, molecular biology or immunohistochemistry (Bcl-1)

• Patient no previous treated.

• At least one tumor site accessible for assessment

• Aged > 18 years < 65

• ECOG < or = 2.

• No other neoplasms apart from resected basal cell carcinoma or in situ carcinoma.

• signed informed consent

• FEVG 50%

Exclusion Criteria:

• other type of lymphoma

• ECOG > or = 3

• relapse

• serology VIH + Hepatite +

• diabetis