Efficacy , Safety of Treatment R NIMP for Relapsed Aggressive Lymphomas

Diffuse Large B-Cell Lymphoma Clinical Trial

Official title:

Phase II Study of Treatment of Relapsed Agressive Lymphomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00842595
• Other study ID #: R NIMP
• Status: Completed
• Phase: Phase 2
• First received: February 11, 2009
• Last updated: July 23, 2013
• Start date: December 2003
• Est. completion date: May 2010

Study information

• Verified date: July 2010
• Source: French Innovative Leukemia Organisation
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diffuse Large B-Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• rituximab
6 courses every 28 days
• vinorelbine
6 courses every 28 days
• ifosfamide
6 courses every 28 days
• Mitoxantrone
6 courses every 28 days
• Prednisone
6 courses every 28 days

Locations

Country	Name	City	State
France	Hôpital COCHIN	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete remission rate		CR AFTER 3 R NIMP COURSES	Yes
Secondary	overall remission rate		OS after 3 R NIMP COURSES	Yes
Secondary	Toxicity		R NIMP TOLERANCE	Yes
Secondary	Pharmacoeconomy		treatment phramacoeconomy	Yes

External Links

•   GOELAMS internet site