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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 16, 2014