Mantel Cell Lymphoma Efficacy of Rituximab Maintenance

French Innovative Leukemia Organisation

Status and phase: Completed; Phase 3

Conditions: Mantle Cell Lymphoma

Treatments: Drug: Rituximab; Other: Watch and wait

Study type: Interventional

Funder types: Other

Identifiers

NCT00921414

Manteau 2007 SJ "LYMA"

Details and patient eligibility

About

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.

Full 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.

Enrollment: 299 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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299 participants in 2 patient groups

1

Active Comparator group

Description:

observation : 3 years maintenance period with assesments and surveillance every 2 months

Treatment:

Other: Watch and wait

2

Experimental group

Description:

maintenance period infusions of Rituximab 375 mg/m2/2 months and assessement and surveillance

Treatment:

Drug: Rituximab