Efficacy , Safety of Treatment R NIMP for Relapsed Aggressive Lymphomas

Sponsor

French Innovative Leukemia Organisation (Other)

Overall Status

Completed

CT.gov ID

NCT00842595

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Diffuse Large B-Cell Lymphoma	Drug: rituximab Drug: vinorelbine Drug: ifosfamide Drug: Mitoxantrone Drug: Prednisone	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Study of Treatment of Relapsed Agressive Lymphomas

Study Start Date :

Dec 1, 2003

Actual Primary Completion Date :

Nov 1, 2009

Actual Study Completion Date :

May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: R NIMP (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 6 courses every 28 days Other Names: (Mabthera ® )Rituximab IV 375 mg/m²day Drug: vinorelbine 6 courses every 28 days Other Names: (Navelbine ®) Vinorelbine IV 25mg/m² day 1 and day 5 Drug: ifosfamide 6 courses every 28 days Other Names: (Holoxan®)Ifostamide 1000mg/m² day 1 to day 5 Drug: Mitoxantrone 6 courses every 28 days Other Names: (Novantrone®) Mitoxantrone 10mg/m² day1 Drug: Prednisone 6 courses every 28 days Other Names: (Cortancyl®)Prednisone 1m/kg day 1 to day 5

Arm

Intervention/Treatment

Experimental: R NIMP

(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

6 courses every 28 days

Other Names:

(Mabthera ® )Rituximab IV 375 mg/m²day

Drug: vinorelbine

6 courses every 28 days

Other Names:

(Navelbine ®) Vinorelbine IV 25mg/m² day 1 and day 5

Drug: ifosfamide

6 courses every 28 days

Other Names:

(Holoxan®)Ifostamide 1000mg/m² day 1 to day 5

Drug: Mitoxantrone

6 courses every 28 days

Other Names:

(Novantrone®) Mitoxantrone 10mg/m² day1

Drug: Prednisone

6 courses every 28 days

Other Names:

(Cortancyl®)Prednisone 1m/kg day 1 to day 5

Outcome Measures

Primary Outcome Measures

Complete remission rate [CR AFTER 3 R NIMP COURSES]

Secondary Outcome Measures

overall remission rate [OS after 3 R NIMP COURSES]
Toxicity [R NIMP TOLERANCE]
Pharmacoeconomy [treatment phramacoeconomy]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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