Phase II Study of Treatment of Relapsed Agressive Lymphomas
Phase II study of the efficacy and toxicity of rituximab, navelbine, ifosfamide,
mitoxantrone, and prednisone in relapsed aggressive non hodgkin's B-cell lymphoma.
The study intervention is an administration of 3 courses of the abovementioned drugs, witch
doses are detailed below. Remission is assessed and the investigator is free to proceed with
any kind of consolidation , he decides best for the patient( high dose or standard
The addition of Rituximab the the NIMP protocol is warranted on the basis of previous
publications wtich have shown a significant advantage in addition to chemotherapy in
complete remission rate and in overall survival.
Navelbine has shown an interesting activity in lymphoma relapse. Mitoxantrone has a good
toxicity profile for patients who have prevously received anthracyclines, and there is not
so much cross resistance between the two drugs.
Ifosfamide is commonly used in the treatment of relapsed and refractory lymphoma, because of
its low hematologic toxicity profile and good antitumor activity.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete remission rate
CR AFTER 3 R NIMP COURSES
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)