Efficacy , Safety of Treatment R NIMP for Relapsed Aggressive Lymphomas

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
ClinicalTrials.gov Identifier:
NCT00842595
First received: February 11, 2009
Last updated: July 23, 2013
Last verified: July 2010
  Purpose

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 Intervention Phase
Diffuse Large B-Cell Lymphoma
Drug: rituximab
Drug: vinorelbine
Drug: ifosfamide
Drug: Mitoxantrone
Drug: Prednisone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Treatment of Relapsed Agressive Lymphomas

Resource links provided by NLM:


Further study details as provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:

Primary Outcome Measures:
  • Complete remission rate [ Time Frame: CR AFTER 3 R NIMP COURSES ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • overall remission rate [ Time Frame: OS after 3 R NIMP COURSES ] [ Designated as safety issue: Yes ]
  • Toxicity [ Time Frame: R NIMP TOLERANCE ] [ Designated as safety issue: Yes ]
  • Pharmacoeconomy [ Time Frame: treatment phramacoeconomy ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: December 2003
Study Completion Date: May 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: (Mabthera ® )Rituximab IV 375 mg/m²day
Drug: vinorelbine
6 courses every 28 days
Other Name: (Navelbine ®) Vinorelbine IV 25mg/m² day 1 and day 5
Drug: ifosfamide
6 courses every 28 days
Other Name: (Holoxan®)Ifostamide 1000mg/m² day 1 to day 5
Drug: Mitoxantrone
6 courses every 28 days
Other Name: (Novantrone®) Mitoxantrone 10mg/m² day1
Drug: Prednisone
6 courses every 28 days
Other Name: (Cortancyl®)Prednisone 1m/kg day 1 to day 5

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00842595

Locations
France
Hôpital COCHIN
Paris, France, 75014
Sponsors and Collaborators
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Investigators
Principal Investigator: Emmanuel GYAN Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
  More Information

Additional Information:
No publications provided

Responsible Party: Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
ClinicalTrials.gov Identifier: NCT00842595     History of Changes
Other Study ID Numbers: R NIMP
Study First Received: February 11, 2009
Last Updated: July 23, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:
relapsed aggressive B-cell lymphoma
Chemotherapy

Additional relevant MeSH terms:
Lymphoma, B-Cell
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Vinorelbine
Mitoxantrone
Prednisone
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids

ClinicalTrials.gov processed this record on September 30, 2014