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
Overview
- Phase
- Phase 3
- Intervention
- Watch and wait
- Conditions
- Mantle Cell Lymphoma
- Sponsor
- French Innovative Leukemia Organisation
- Enrollment
- 299
- Locations
- 1
- Primary Endpoint
- event-free survival (EFS) post Rituximab maintenance therapy
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •mantle cell lymphoma
- •Initial immunophenotyping with CD20 and CD
- •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 =
- •No other neoplasms apart from resected basal cell carcinoma or in situ carcinoma.
- •signed informed consent
Exclusion Criteria
- •other type of lymphoma
- •ECOG \> or = 3
- •serology VIH + Hepatite +
Arms & Interventions
1
observation : 3 years maintenance period with assesments and surveillance every 2 months
Intervention: Watch and wait
2
maintenance period infusions of Rituximab 375 mg/m2/2 months and assessement and surveillance
Intervention: Rituximab
Outcomes
Primary Outcomes
event-free survival (EFS) post Rituximab maintenance therapy
Time Frame: EFS post 4 years after maintenance
Secondary Outcomes
- 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)