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Mantel Cell Lymphoma Efficacy of Rituximab Maintenance

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ClinicalTrials.gov Identifier: NCT00921414
Recruitment Status : Completed
First Posted : June 16, 2009
Last Update Posted : April 27, 2018
Sponsor:
Collaborator:
Lymphoma Study Association
Information provided by (Responsible Party):
French Innovative Leukemia Organisation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mantle Cell Lymphoma Drug: Rituximab Other: Watch and wait Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 299 participants
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
Study Start Date : September 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arms and Interventions
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Arm Intervention/treatment
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®


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

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
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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
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France
Regional University Hospital
Nantes, France, 44093
Sponsors and Collaborators
French Innovative Leukemia Organisation
Lymphoma Study Association
Investigators
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Principal Investigator: Steven LE GOUILL, MD French Innovative Leukemia Organisation
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: French Innovative Leukemia Organisation
ClinicalTrials.gov Identifier: NCT00921414    
Other Study ID Numbers: Manteau 2007 SJ "LYMA"
First Posted: June 16, 2009    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
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:
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Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents