NCT00842595

Efficacy , Safety of Treatment R NIMP for Relapsed Aggressive Lymphomas

Phase II Study of Treatment of Relapsed Agressive Lymphomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: French Innovative Leukemia Organisation · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	rituximab	6 courses every 28 days
DRUG	vinorelbine	6 courses every 28 days
DRUG	ifosfamide	6 courses every 28 days
DRUG	Mitoxantrone	6 courses every 28 days
DRUG	Prednisone	6 courses every 28 days

Timeline

• Start date: 2003-12-01
• Primary completion: 2009-11-01
• Completion: 2010-05-01
• First posted: 2009-02-12
• Last updated: 2013-07-24

Locations

1 site across 1 country: France