Mantel Cell Lymphoma Efficacy of Rituximab Maintenance

Phase 3

Completed

• Conditions: Mantle Cell Lymphoma
• Interventions: Other: Watch and wait; Drug: Rituximab

• Registration Number: NCT00921414
• Lead Sponsor: French Innovative Leukemia Organisation

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2008-09
• Study First Submitted: 2009-05-27
• Study First Submitted QC: 2009-06-15
• Study First Posted: 2009-06-16
• Study Completion: 2017-02
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-26
• Last Update Posted: 2018-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 299

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%

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Exclusion Criteria

• other type of lymphoma
• ECOG > or = 3
• relapse
• serology VIH + Hepatite +
• diabetis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Watch and wait	observation : 3 years maintenance period with assesments and surveillance every 2 months
2	Rituximab	maintenance period infusions of Rituximab 375 mg/m2/2 months and assessement and surveillance

Primary Outcome Measures

Name	Time	Method
event-free survival (EFS) post Rituximab maintenance therapy	EFS post 4 years after maintenance

Secondary Outcome Measures

Name	Time	Method
duration of OS of the entire group of patients	safety/efficacy of treatment
complete, partial and overall response rate after induction with R-DHAP and after ASCT.	safety/efficacy of all the treatment
duration of PFS of the entire group of patients.	Safety/efficacy of maintenance treatment

Trial Locations

Locations (1)

Regional University Hospital; 🇫🇷 Nantes, France