Phase II Study of Treatment of Relapsed Agressive Lymphomas
18 Years
75 Years
Both
B-cell Diffuse Large Cell Non Hodgkin's Lymphoma
Trial Information
Phase II Study of Treatment of Relapsed Agressive Lymphomas
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete remission rate
Outcome Time Frame:
CR AFTER 3 R NIMP COURSES
Safety Issue:
Yes
Principal Investigator
Emmanuel GYAN
Investigator Role:
Principal Investigator
Investigator Affiliation:
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
R NIMP
NCT ID:
NCT00842595
Start Date:
December 2003
Completion Date:
May 2010
Related Keywords:
- B-cell Diffuse Large Cell Non Hodgkin's Lymphoma
- relapsed aggressive B-cell lymphoma
- Chemotherapy
- Lymphoma
- Lymphoma, Non-Hodgkin
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