Safety and Efficacy of Ibritumomab Tiuxetan (Zevalin®) in Association With a Fludarabine Based Reduced Conditioning Regimen and Allogenic Stem Cell Support in Chemo-sensitive Relapsed CD20 Positive Aggressive Non-Hodgkin's Lymphoma Patients.
The benefit of Zevalin® in the setting of autologous stem cell transplantation has been
largely reported. The addition of Zevalin® to a fludarabine-based Reduced Intensity
Conditioning regimen has been already evaluated in the setting of allo-SCT and the results
reported so far seem to be promising without an overwhelming toxicity neither a delayed
hematologic recovery. The assumption that the addition of Zevalin® to the conditioning
regimen might improve lymphoma control and the demonstration that nucleoside analogs such as
fludarabine synergize optimally with RIT led us to conduct this trial using the following
preparative regimen: rituximab 250 mg/m² on days -21 and -14, Zevalin® 0,4 mCi/Kg body
weight on day -14, fludarabine 30 mg/m² intravenously from days -6 to -2, Busulfan orally (4
mg/Kg body weight) or intravenously (0,8 mg/Kg body weight) on days -5 and -4 and ATG
(Thymoglobulin®) 2,5 mg/Kg body weight intravenously on day -1. Cyclosporine A is
administered at 2 or 3 mg/Kg body weight from day -1 to day 28 than followed by a dose
reduction.
The purpose of this study is to evaluate the safety and efficacy of Zevalin® in a Reduced
Intensity Conditioning regimen followed by allogenic stem cell support in patients with
aggressive lymphomas who are responsive to a salvage chemotherapy regimen
Patients are followed from the beginning of the RIC regimen until day 365 for primary and
secondary objectives of the study than on a regular basis depending on the practice of each
centre. The evaluation includes physical examination (performance status, hematologic
assessment, acute and chronic GVH disease), biologic tests (blood screening for blood count,
renal and hepatic function, B and T-cell recovery, chimerism analysis, response assessment)
and complementary examinations (marrow biopsies, tomography scan, positron emission
tomography, …).
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
the treatment-related mortality rate (except if the death is related to the lymphoma exclusively).
day 100 post transplant
Yes
Krimo BOUABDALLAH, MD
Principal Investigator
University Hospital Bordeaux, France
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
CHUBX 2007/11
NCT00607854
February 2008
November 2011
Name | Location |
---|