Mantel Cell Lymphoma Efficacy of Rituximab Maintenance

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Mantle Cell Lymphoma

Intervention / Treatment
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* Drug: Rituximab
* Other: Watch and wait


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>observation : 3 years maintenance period with assesments and surveillance every 2 months | Other: Watch and wait<br>* No treatment patient follow-up every 2 months during 3 years<br>* Other names: observation;|
| Experimental: 2<br>maintenance period infusions of Rituximab 375 mg/m2/2 months and assessement and surveillance | Drug: Rituximab<br>* 2 months after ASCT maintenance treatment with Rituximab 500mg/m² IV every 2 months during 3 years<br>* Other names: Mabthera®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| event-free survival (EFS) post Rituximab maintenance therapy |  | EFS post 4 years after maintenance | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of PFS of the entire group of patients. |  | Safety/efficacy of maintenance treatment | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mantle cell lymphoma, R DHAP, ASCT, Rituximab Maintenance