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Mantel Cell Lymphoma Efficacy of Rituximab Maintenance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00921414
First Posted: June 16, 2009
Last Update Posted: February 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Lymphoma Study Association
Information provided by (Responsible Party):
French Innovative Leukemia Organisation
  Purpose
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.

Condition Intervention Phase
Mantle Cell Lymphoma Drug: Rituximab Other: Watch and wait Phase 3

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

Resource links provided by NLM:


Further study details as provided by French Innovative Leukemia Organisation:

Primary Outcome Measures:
  • event-free survival (EFS) post Rituximab maintenance therapy [ Time Frame: EFS post 4 years after maintenance ]

Secondary Outcome Measures:
  • duration of PFS of the entire group of patients. [ Time Frame: Safety/efficacy of maintenance treatment ]
  • duration of OS of the entire group of patients [ Time Frame: safety/efficacy of treatment ]
  • complete, partial and overall response rate after induction with R-DHAP and after ASCT. [ Time Frame: safety/efficacy of all the treatment ]

Enrollment: 299
Study Start Date: September 2008
Study Completion Date: February 2017
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
observation : 3 years maintenance period with assesments and surveillance every 2 months
Other: Watch and wait
No treatment patient follow-up every 2 months during 3 years
Other Name: observation
Experimental: 2
maintenance period infusions of Rituximab 375 mg/m2/2 months and assessement and surveillance
Drug: Rituximab
2 months after ASCT maintenance treatment with Rituximab 500mg/m² IV every 2 months during 3 years
Other Name: Mabthera®

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00921414


Locations
France
Regional University Hospital
Nantes, France, 44093
Sponsors and Collaborators
French Innovative Leukemia Organisation
Lymphoma Study Association
Investigators
Principal Investigator: Steven LE GOUILL, MD French Innovative Leukemia Organisation
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: French Innovative Leukemia Organisation
ClinicalTrials.gov Identifier: NCT00921414     History of Changes
Other Study ID Numbers: Manteau 2007 SJ "LYMA"
First Submitted: May 27, 2009
First Posted: June 16, 2009
Last Update Posted: February 15, 2017
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by French Innovative Leukemia Organisation:
Mantle cell lymphoma
R DHAP
ASCT
Rituximab Maintenance

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents