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Efficacy , Safety of Treatment R NIMP for Relapsed Aggressive Lymphomas

This study has been completed.
Information provided by (Responsible Party):
French Innovative Leukemia Organisation Identifier:
First received: February 11, 2009
Last updated: July 23, 2013
Last verified: July 2010
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: 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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00842595

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

Additional Information:
Responsible Party: French Innovative Leukemia Organisation Identifier: NCT00842595     History of Changes
Other Study ID Numbers: R NIMP
Study First Received: February 11, 2009
Last Updated: July 23, 2013

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

Additional relevant MeSH terms:
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators processed this record on May 24, 2017