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NCT Number: NCT00921414

Mantel Cell Lymphoma Efficacy of Rituximab Maintenance

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.

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Key information

Conditions

Mantle Cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Regional University Hospital

Nantes, 44093, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rituximab

Drug

2 months after ASCT maintenance treatment with Rituximab 500mg/m² IV every 2 months during 3 years

Other names: Mabthera®

Watch and wait

Other

No treatment patient follow-up every 2 months during 3 years

Other names: observation

Primary outcomes

  1. event-free survival (EFS) post Rituximab maintenance therapy

    Time frame: EFS post 4 years after maintenance

Secondary outcomes

  1. duration of PFS of the entire group of patients.

    Time frame: Safety/efficacy of maintenance treatment

  2. duration of OS of the entire group of patients

    Time frame: safety/efficacy of treatment

  3. complete, partial and overall response rate after induction with R-DHAP and after ASCT.

    Time frame: safety/efficacy of all the treatment

Sponsors and collaborators

Lead sponsor

French Innovative Leukemia Organisation

Other

Collaborators

  • Lymphoma Study Association

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2017
First posted
Jun 16, 2009
Registry last updated
Apr 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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