Mantel Cell Lymphoma Efficacy of Rituximab Maintenance

Mantle Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00921414
• Other study ID #: Manteau 2007 SJ "LYMA"
• Status: Completed
• Phase: Phase 3
• First received: May 27, 2009
• Last updated: April 26, 2018
• Start date: September 2008
• Est. completion date: February 2017

Study information

• Verified date: April 2018
• Source: French Innovative Leukemia Organisation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: February 2017
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma

Intervention

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

Locations

Country	Name	City	State
France	Regional University Hospital	Nantes

Sponsors (2)

Lead Sponsor	Collaborator
French Innovative Leukemia Organisation	Lymphoma Study Association

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	event-free survival (EFS) post Rituximab maintenance therapy		EFS post 4 years after maintenance
Secondary	duration of PFS of the entire group of patients.		Safety/efficacy of maintenance treatment
Secondary	duration of OS of the entire group of patients		safety/efficacy of treatment
Secondary	complete, partial and overall response rate after induction with R-DHAP and after ASCT.		safety/efficacy of all the treatment

External Links

•   FILO Website