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.
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, …).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Conditioning regimen followed by allogeneic hematopoietic stem cell transplantation. Ibritumomab Tiuxetan(Zevalin): 0.4 mCi/kg IV at day -14 (Day 0 is the transplantation)
Service d'hématologie - CHU de Besançon
Besançon, France
Service des maladies du sang - Hôpital Haut-Lévêque - avenue de magellan
Bordeaux - Pessac, France
Service d'hématologie - CHU Hôtel Dieu Clermont-Ferrand
the treatment-related mortality rate (except if the death is related to the lymphoma exclusively).
Time frame: day 100 post transplant
The event-free-survival (EFS)(an event is defined as: death from any cause, relapse or progression, need to another treatment except for donor-lymphocytes injection (DLI), patient lost for follow-up)
Time frame: 1 year post transplant
The rate of hematologic recovery (defined as ANC above 500/mm3 and platelets count above 20.000/mm3 for three consecutive days without stimulating growth support neither platelet transfusion)
Time frame: day 30
Biological post allogenic effects of Zevalin® on the incidence of GVHD and B-cell and T-cell reconstitution
Time frame: days d0, d28, d90, d180 and 1 year
Chimérism
Time frame: day d28, d56, d 80, 1 year than at least once a year
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Clermont-Ferrand, France
Service de médecine nucléaire - Centre de Lutte contre le Cancer de la Région Auvergne Jean Perrin
Clermont-Ferrand, France
Hôpital Edouard Herriot
Lyon, France
Service d'Oncologie Hématologie, Institut Paoli Calmettes - 232 Bd Ste Marguerite
Marseille, France
Hématologie et Oncologie médicale - CHU Lapeyronie
Montpellier, France
Service d'Hématologie, Hôpital Hôtel Dieu, CHU Nantes - 1 Place Alexis Ricordeau
Nantes, France
Service d'hématologie clinique - Hôpital l'Archet 1
Nice, France
Service d'Hématologie Adultes - Hôpital Necker-Enfants Malade
Paris, France
...and 2 more locations