DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Efficacy , Safety of Treatment R NIMP for Relapsed Aggressive Lymphomas

Information source: Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diffuse Large B-Cell Lymphoma

Intervention: rituximab (Drug); vinorelbine (Drug); ifosfamide (Drug); Mitoxantrone (Drug); Prednisone (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Official(s) and/or principal investigator(s):
Emmanuel GYAN, Principal Investigator, Affiliation: Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

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

Clinical Details

Official title: Phase II Study of Treatment of Relapsed Agressive Lymphomas

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

Primary outcome: Complete remission rate

Secondary outcome:

overall remission rate

Toxicity

Pharmacoeconomy

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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Hôpital COCHIN, Paris 75014, France
Additional Information

GOELAMS internet site

Starting date: December 2003
Last updated: July 23, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017