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Phase III Study of Treatment of Disseminated and Agressive Lymphoma R CHOP Versus R CLOP( With Liposomal Doxorubicin)


Phase 2/Phase 3
60 Years
75 Years
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Phase III Study of Treatment of Disseminated and Agressive Lymphoma R CHOP Versus R CLOP( With Liposomal Doxorubicin)


R CHOP is a good standard in the treatment of diffuse high grade lymphoma. Howeverin elderly
patients it is often toxic, specially with haematologic and cardiac toxicities.


Inclusion Criteria:



- high grade lymphoma

- disseminated

- > 60 years old and < 75

- informed consent signed

- cardiac state compatible with antracyclin

- ECOG
Exclusion Criteria:

- patients > 75 years old

- Cardiac insufficiency

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:

hematologic toxicity

Outcome Time Frame:

6 months

Principal Investigator

Guillaume CARTRON, Dr

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:

GOELAMS 0804

NCT ID:

NCT00536393

Start Date:

October 2000

Completion Date:

October 2004

Related Keywords:

  • Lymphoma
  • diffuse larg cells lymphoma
  • chemotherapy
  • toxicity
  • diffuse high grade lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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