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Efficacy , Safety of Treatment R NIMP for Relapsed Aggressive Lymphomas

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00842595
First Posted: February 12, 2009
Last Update Posted: July 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
French Innovative Leukemia Organisation
  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: Intervention Model: Single Group Assignment
Masking: None (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 French Innovative Leukemia Organisation:

Primary Outcome Measures:
  • Complete remission rate [ Time Frame: CR AFTER 3 R NIMP COURSES ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00842595


Locations
France
Hôpital COCHIN
Paris, France, 75014
Sponsors and Collaborators
French Innovative Leukemia Organisation
Investigators
Principal Investigator: Emmanuel GYAN French Innovative Leukemia Organisation
  More Information

Additional Information:
Responsible Party: French Innovative Leukemia Organisation
ClinicalTrials.gov Identifier: NCT00842595     History of Changes
Other Study ID Numbers: R NIMP
First Submitted: February 11, 2009
First Posted: February 12, 2009
Last Update Posted: July 24, 2013
Last Verified: July 2010

Keywords provided by French Innovative Leukemia Organisation:
relapsed aggressive B-cell lymphoma
Chemotherapy

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Vinorelbine
Rituximab
Prednisone
Vinblastine
Ifosfamide
Mitoxantrone
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action