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History of Changes for Study: NCT00921414
Mantel Cell Lymphoma Efficacy of Rituximab Maintenance
Latest version (submitted April 26, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 15, 2009 None (earliest Version on record)
2 June 19, 2009 Study Status
3 February 22, 2011 Arms and Interventions, Study Status and Study Identification
4 October 18, 2011 Sponsor/Collaborators and Study Status
5 October 21, 2011 Contacts/Locations and Study Status
6 October 24, 2012 Recruitment Status, Study Status, Contacts/Locations and Study Design
7 March 15, 2016 Study Status, IPDSharing, References and Study Identification
8 February 14, 2017 Study Status
9 April 26, 2018 Study Status
Comparison Format:
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Study NCT00921414
Submitted Date:  June 15, 2009 (v1)
Open or close this module Study Identification
Unique Protocol ID: Manteau 2007 SJ "LYMA"
Brief Title: Mantel Cell Lymphoma Efficacy of Rituximab Maintenance
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
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2009
Overall Status: Recruiting
Study Start: September 2008
Primary Completion: September 2008 [Actual]
Study Completion: September 2011 [Anticipated]
First Submitted: May 27, 2009
First Submitted that
Met QC Criteria:		 June 15, 2009
First Posted: June 16, 2009 [Estimate]
Last Update Submitted that
Met QC Criteria:		 June 15, 2009
Last Update Posted: June 16, 2009 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: French Innovative Leukemia Organisation
Responsible Party:
Collaborators: Lymphoma Study Association
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.
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.
Open or close this module Conditions
Conditions: Mantle Cell Lymphoma
Keywords: Mantle cell lymphoma
R DHAP
ASCT
Rituximab Maintenance
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 199 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: 1
observation
Watch and wait
No treatment patient follow-up every 2 months during 3 years
Other Names:
  • observation
Experimental: 2
43 years Rituximab maintenance
 Drug: Rituximab
2 months after ASCT maintenance treatment with Rituximab 500mg/m² IV every 2 months during 3 years
Other Names:
  • Mabthera®
Open or close this module Outcome Measures
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 ]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Steven LE GOUILL, MD
Telephone: +.33 2 40 08 32 71
Email: steven.legouill@chu-nantes.fr
Central Contact Backup: Valerie ROLLAND NEYRET, CRA
Telephone: + 33 4 76 76 50 96
Email: VRolland-neyret@chu-grenoble.fr
Study Officials: Steven LE GOUILL, MD
Principal Investigator
French Innovative Leukemia Organisation
Locations: France
Regional University Hospital
[Recruiting]
Nantes, France, 44093
Contact:Contact: Steven LE GOUILL, MD + 33 2 40 08 32 71 steven.legouill@chu-nantes.fr
Contact:Contact: Karine ROLLAND NEYRET, CRA + 33 2 40 08 30 13 karine.duperrier@chu-nantes.fr
Contact:Principal Investigator: Steven LE GOUILL, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
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