Text Size

Efficacy , Safety of Treatment R NIMP for Relapsed Aggressive Lymphomas

This study has been completed.
Sponsor:
Information provided by:
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 12, 2010
Last verified: July 2010
History of Changes

February 11, 2009
July 12, 2010
December 2003
November 2009   (final data collection date for primary outcome measure)
Complete remission rate [ Time Frame: CR AFTER 3 R NIMP COURSES ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00842595 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy , Safety of Treatment R NIMP for Relapsed Aggressive Lymphomas
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

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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
B-cell Diffuse Large Cell Non Hodgkin's Lymphoma
  • Drug: rituximab
  • Drug: navelbine
  • Drug: ifosfamide
  • Drug: Mitoxantrone
  • Drug: Prednisone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
May 2010
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00842595
R NIMP
Yes
Groupe est ouest Leucémies et autres maladies du sang, DR Emamnuel GYAN
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Not Provided
Principal Investigator: Emmanuel GYAN Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP