Pilot multicentre, open label study with the aim to evaluate antitumor activity in term of the sum of complete and partial response (O.R.R.) of chemotherapy (cyclophosphamide and fludarabine) and rituximab, followed by zevalin radioimmunotherapy and response duration (Time to relapse or progression)and to evaluate the safety of the treatment as acute and late toxicity. Secondary objective is to evaluate the overall survival (OS) and the event-free survival (EFS).
Test medication: * Yttrium-90 (90Y) ibritumomab tiuxetan 0.4 mCi/kg is delivered to patient achieving at least a partial remission (PR) after chemotherapy as a single dose for patients with baseline platelet counts\>150x10\^9/L or 0.3 mCi/kg for patients with baseline platelet counts of 100 to 149x10\^9/L. Rituximab 250mg/sqm is given prior to therapeutic radiolabeled antibodies. * Standard dose chemotherapy consisting of cyclophosphamide, fludarabine and rituximab given every 28 days up to the best response (maximum 6 courses). * A prophylaxis for pneumocystis carinii as well as for herpes zoster are needed during treatment. Main parameters of activity: activity of Yttrium-90 (90Y) ibritumomab tiuxetan after cyclophosphamide, fludarabine and rituximab combination.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Yttrium-90 (90Y) ibritumomab tiuxetan 0.4 mCi/kg is delivered to patient achieving at least a partial remission (PR) after chemotherapy as a single dose for patients with baseline platelet counts\>150x10\^9/L or 0.3 mCi/kg for patients with baseline platelet counts of 100 to 149x10\^9/L. Rituximab 250mg/sqm is given prior to therapeutic radiolabeled antibodies.
USC Ematologia Ospedali Riuniti di Bergamo
Bergamo, BG, Italy
U.O. Ematologia Ospedali Civili Brescia
Brescia, BS, Italy
Medicina Nucleare ed Oncologia Medica AOU Policlinico Universitario di Messina
Messina, ME, Italy
Istituto per la Ricerca e la Cura del Cancro IRCC
Candiolo, TO, Italy
achievement and duration of complete or partial reduction of lymphnodes six weeks after the end of treatment with zevalin
Time frame: 2 years
overall and event free survival
Time frame: 2 years
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SC Ematologia 2 ASO S. Giovanni Battista
Torino, TO, Italy
U.O. Ematologia Ospedale Cà Foncello
Treviso, TV, Italy