Efficacy , Safety of Treatment R NIMP for Relapsed Aggressive Lymphomas

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Phase II Study of Treatment of Relapsed Agressive Lymphomas

Conditions
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Diffuse Large B-Cell Lymphoma

Intervention / Treatment
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* Drug: rituximab
* Drug: vinorelbine
* Drug: ifosfamide
* Drug: Mitoxantrone
* Drug: Prednisone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both genders, between 18 and 75 years old CD 20+ large cell lymphoma In first relapse No previous autologous stem cell transplantation or relapsing more than 12 months after an autologous stem cell transplantation Ann Arbor stage I, II, III ou IV ECOG 0,1 or 2 Signed informed consent Exclusion Criteria: age: before 18 and more than 75 years old other type of lymphoma Informed consent not signed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: R NIMP<br>(Mabthera®) Rituximab IV 375 mg/m²day 1 (Navelbine ®)Vinorelbine IV 25mg/m² day 1 and day 5 (Novantrone®)Mitoxantrone IV 10 mg/m² day 1 (Holoxan®)Ifostamide IV 1000 mg/m²day 1 to day 5 (Cortancyl®)prednisone oral day 1 to day 5 | Drug: rituximab<br>* 6 courses every 28 days<br>* Other names: (Mabthera ® )Rituximab IV 375 mg/m²day;Drug: vinorelbine<br>* 6 courses every 28 days<br>* Other names: (Navelbine ®) Vinorelbine IV 25mg/m² day 1 and day 5;Drug: ifosfamide<br>* 6 courses every 28 days<br>* Other names: (Holoxan®)Ifostamide 1000mg/m² day 1 to day 5;Drug: Mitoxantrone<br>* 6 courses every 28 days<br>* Other names: (Novantrone®) Mitoxantrone 10mg/m² day1;Drug: Prednisone<br>* 6 courses every 28 days<br>* Other names: (Cortancyl®)Prednisone 1m/kg day 1 to day 5;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete remission rate |  | CR AFTER 3 R NIMP COURSES | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall remission rate |  | OS after 3 R NIMP COURSES | 
| Toxicity |  | R NIMP TOLERANCE | 
| Pharmacoeconomy |  | treatment phramacoeconomy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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relapsed aggressive B-cell lymphoma, Chemotherapy