Mantel Cell Lymphoma Efficacy of Rituximab Maintenance

This study has been completed.
Sponsor:
Collaborator:
Lymphoma Study Association
Information provided by (Responsible Party):
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
ClinicalTrials.gov Identifier:
NCT00921414
First received: May 27, 2009
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Mantle Cell Lymphoma
Drug: Rituximab
Other: Watch and wait
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:

Primary Outcome Measures:
  • event-free survival (EFS) post Rituximab maintenance therapy [ Time Frame: EFS post 4 years after maintenance ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • duration of PFS of the entire group of patients. [ Time Frame: Safety/efficacy of maintenance treatment ] [ Designated as safety issue: Yes ]
  • duration of OS of the entire group of patients [ Time Frame: safety/efficacy of treatment ] [ Designated as safety issue: Yes ]
  • complete, partial and overall response rate after induction with R-DHAP and after ASCT. [ Time Frame: safety/efficacy of all the treatment ] [ Designated as safety issue: Yes ]

Enrollment: 299
Study Start Date: September 2008
Study Completion Date: August 2012
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00921414

Locations
France
Regional University Hospital
Nantes, France, 44093
Sponsors and Collaborators
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Lymphoma Study Association
Investigators
Principal Investigator: Steven LE GOUILL, MD Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
  More Information

Additional Information:
No publications provided

Responsible Party: Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
ClinicalTrials.gov Identifier: NCT00921414     History of Changes
Other Study ID Numbers: Manteau 2007 SJ "LYMA"
Study First Received: May 27, 2009
Last Updated: October 24, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:
Mantle cell lymphoma
R DHAP
ASCT
Rituximab Maintenance

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 17, 2014