Efficacy , Safety of Treatment R NIMP for Relapsed Aggressive Lymphomas
The primary objective of the protocol is to estimate the complete response rate of three courses of the association of rituximab, navelbine, ifosfamide, mitoxantrone, and prednisone in relapsed aggressive non hodgkin's B-cell lymphoma
B-cell Diffuse Large Cell Non Hodgkin's Lymphoma
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Treatment of Relapsed Agressive Lymphomas|
- Complete remission rate [ Time Frame: CR AFTER 3 R NIMP COURSES ] [ Designated as safety issue: Yes ]
- overall remission rate [ Time Frame: OS after 3 R NIMP COURSES ] [ Designated as safety issue: Yes ]
- Toxicity [ Time Frame: R NIMP TOLERANCE ] [ Designated as safety issue: Yes ]
- Pharmacoeconomy [ Time Frame: treatment phramacoeconomy ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2003|
|Study Completion Date:||May 2010|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
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 chemotherapy).
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.
|Paris, France, 75014|
|Principal Investigator:||Emmanuel GYAN||Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS|