Efficacy , Safety of Treatment R NIMP for Relapsed Aggressive Lymphomas

French Innovative Leukemia Organisation

Status and phase: Completed; Phase 2

Conditions: Diffuse Large B-Cell Lymphoma

Treatments: Drug: Prednisone; Drug: vinorelbine; Drug: Mitoxantrone; Drug: rituximab; Drug: ifosfamide

Study type: Interventional

Funder types: Other

Identifiers

NCT00842595

R NIMP

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

R NIMP

Experimental group

Description:

(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

Treatment:

Drug: ifosfamide

Drug: rituximab

Drug: Mitoxantrone

Drug: vinorelbine

Drug: Prednisone