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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

Tracking Information
First Submitted Date  ICMJE May 27, 2009
First Posted Date  ICMJE June 16, 2009
Last Update Posted Date April 27, 2018
Study Start Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2009)
event-free survival (EFS) post Rituximab maintenance therapy [ Time Frame: EFS post 4 years after maintenance ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mantel Cell Lymphoma Efficacy of Rituximab Maintenance
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mantle Cell Lymphoma
Intervention  ICMJE
  • Drug: Rituximab
    2 months after ASCT maintenance treatment with Rituximab 500mg/m² IV every 2 months during 3 years
    Other Name: Mabthera®
  • Other: Watch and wait
    No treatment patient follow-up every 2 months during 3 years
    Other Name: observation
Study Arms  ICMJE
  • Active Comparator: 1
    observation : 3 years maintenance period with assesments and surveillance every 2 months
    Intervention: Other: Watch and wait
  • Experimental: 2
    maintenance period infusions of Rituximab 375 mg/m2/2 months and assessement and surveillance
    Intervention: Drug: Rituximab
Publications * Le Gouill S, Thieblemont C, Oberic L, Moreau A, Bouabdallah K, Dartigeas C, Damaj G, Gastinne T, Ribrag V, Feugier P, Casasnovas O, Zerazhi H, Haioun C, Maisonneuve H, Houot R, Jardin F, Van Den Neste E, Tournilhac O, Le Dû K, Morschhauser F, Cartron G, Fornecker LM, Canioni D, Callanan M, Béné MC, Salles G, Tilly H, Lamy T, Gressin R, Hermine O; LYSA Group. Rituximab after Autologous Stem-Cell Transplantation in Mantle-Cell Lymphoma. N Engl J Med. 2017 Sep 28;377(13):1250-1260. doi: 10.1056/NEJMoa1701769.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 24, 2012)
299
Original Estimated Enrollment  ICMJE
 (submitted: June 15, 2009)
199
Actual Study Completion Date  ICMJE February 2017
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00921414
Other Study ID Numbers  ICMJE Manteau 2007 SJ "LYMA"
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party French Innovative Leukemia Organisation
Study Sponsor  ICMJE French Innovative Leukemia Organisation
Collaborators  ICMJE Lymphoma Study Association
Investigators  ICMJE
Principal Investigator: Steven LE GOUILL, MD French Innovative Leukemia Organisation
PRS Account French Innovative Leukemia Organisation
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP