Efficacy , Safety of Treatment R NIMP for Relapsed Aggressive Lymphomas

July 23, 2013 updated by: French Innovative Leukemia Organisation

Phase II Study of Treatment of Relapsed Agressive Lymphomas

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Hôpital Cochin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • (Mabthera ® )Rituximab IV 375 mg/m²day
Drug: vinorelbine
6 courses every 28 days
Other Names:
  • (Navelbine ®) Vinorelbine IV 25mg/m² day 1 and day 5
Drug: ifosfamide
6 courses every 28 days
Other Names:
  • (Holoxan®)Ifostamide 1000mg/m² day 1 to day 5
Drug: Mitoxantrone
6 courses every 28 days
Other Names:
  • (Novantrone®) Mitoxantrone 10mg/m² day1
Drug: Prednisone
6 courses every 28 days
Other Names:
  • (Cortancyl®)Prednisone 1m/kg day 1 to day 5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete remission rate
Time Frame: CR AFTER 3 R NIMP COURSES
CR AFTER 3 R NIMP COURSES

Secondary Outcome Measures

Outcome Measure
Time Frame
overall remission rate
Time Frame: OS after 3 R NIMP COURSES
OS after 3 R NIMP COURSES
Toxicity
Time Frame: R NIMP TOLERANCE
R NIMP TOLERANCE
Pharmacoeconomy
Time Frame: treatment phramacoeconomy
treatment phramacoeconomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Innovative Leukemia Organisation

Investigators

  • Principal Investigator: Emmanuel GYAN, French Innovative Leukemia Organisation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

February 11, 2009

First Submitted That Met QC Criteria

February 11, 2009

First Posted (Estimate)

February 12, 2009

Study Record Updates

Last Update Posted (Estimate)

July 24, 2013

Last Update Submitted That Met QC Criteria

July 23, 2013

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R NIMP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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