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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


Phase 3
18 Years
65 Years
Not Enrolling
Both
Mantle Cell Lymphoma

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

event-free survival (EFS) post Rituximab maintenance therapy

Outcome Time Frame:

EFS post 4 years after maintenance

Safety Issue:

Yes

Principal Investigator

Steven LE GOUILL, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

Manteau 2007 SJ "LYMA"

NCT ID:

NCT00921414

Start Date:

September 2008

Completion Date:

August 2012

Related Keywords:

  • Mantle Cell Lymphoma
  • Mantle cell lymphoma
  • R DHAP
  • ASCT
  • Rituximab Maintenance
  • Lymphoma
  • Lymphoma, Mantle-Cell

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