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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
May 27, 2009
June 16, 2009
February 15, 2017
September 2008
September 2008   (Final data collection date for primary outcome measure)
event-free survival (EFS) post Rituximab maintenance therapy [ Time Frame: EFS post 4 years after maintenance ]
Same as current
Complete list of historical versions of study NCT00921414 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Mantel Cell Lymphoma Efficacy of Rituximab Maintenance
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
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Mantle Cell Lymphoma
  • 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
  • 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
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.
 
Completed
299
February 2017
September 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00921414
Manteau 2007 SJ "LYMA"
Yes
Not Provided
Plan to Share IPD: No
French Innovative Leukemia Organisation
French Innovative Leukemia Organisation
Lymphoma Study Association
Principal Investigator: Steven LE GOUILL, MD French Innovative Leukemia Organisation
French Innovative Leukemia Organisation
March 2016

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