Mantel Cell Lymphoma Efficacy of Rituximab Maintenance

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

Tracking Information

• First Submitted Date: May 27, 2009
• First Posted Date: June 16, 2009
• Last Update Posted Date: April 27, 2018
• Study Start Date: September 2008
• Actual Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 15, 2009): event-free survival (EFS) post Rituximab maintenance therapy [ Time Frame: EFS post 4 years after maintenance ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Mantle Cell Lymphoma

Intervention

• 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

• 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 Du K, Morschhauser F, Cartron G, Fornecker LM, Canioni D, Callanan M, Bene 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 24, 2012): 299
• Original Estimated Enrollment (submitted: June 15, 2009): 199
• Actual Study Completion Date: February 2017
• Actual Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT00921414
• Other Study ID Numbers: Manteau 2007 SJ "LYMA"
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: French Innovative Leukemia Organisation
• Original Responsible Party: Manteau 2007 SJ (Young Subjects) "LyMa", GOELAMS
• Current Study Sponsor: French Innovative Leukemia Organisation
• Original Study Sponsor: Same as current
• Collaborators: Lymphoma Study Association

Investigators

• Principal Investigator: Steven LE GOUILL, MD; French Innovative Leukemia Organisation

• PRS Account: French Innovative Leukemia Organisation
• Verification Date: April 2018