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Completed

NCT Number: NCT00842595

Efficacy , Safety of Treatment R NIMP for Relapsed Aggressive 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

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Key information

Conditions

Diffuse Large B-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hôpital COCHIN

Paris, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rituximab

Drug

6 courses every 28 days

Other names: (Mabthera ® )Rituximab IV 375 mg/m²day

Vinorelbine

Drug

6 courses every 28 days

Other names: (Navelbine ®) Vinorelbine IV 25mg/m² day 1 and day 5

ifosfamide

Drug

6 courses every 28 days

Other names: (Holoxan®)Ifostamide 1000mg/m² day 1 to day 5

Mitoxantrone

Drug

6 courses every 28 days

Other names: (Novantrone®) Mitoxantrone 10mg/m² day1

Prednisone

Drug

6 courses every 28 days

Other names: (Cortancyl®)Prednisone 1m/kg day 1 to day 5

Primary outcomes

  1. Complete remission rate

    Time frame: CR AFTER 3 R NIMP COURSES

Secondary outcomes

  1. overall remission rate

    Time frame: OS after 3 R NIMP COURSES

  2. Toxicity

    Time frame: R NIMP TOLERANCE

  3. Pharmacoeconomy

    Time frame: treatment phramacoeconomy

Sponsors and collaborators

Lead sponsor

French Innovative Leukemia Organisation

Other

Registry information

Official study title

Phase II Study of Treatment of Relapsed Agressive Lymphomas

Important dates

Study start
2003
Primary completion
2009
Study completion
2010
First posted
Feb 12, 2009
Registry last updated
Jul 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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