This is a prospective, multicenter phase II trial designed to evaluate the safety and activity of the combination of association of arsenic trioxide (ATO) and ascorbic acid in patients with myelodysplastic syndromes
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
ATO will be diluted in 250 ml of normal saline solution at a dosage of 0.3 mg/Kg during the first week of therapy and at a dosage of 0.25 mg/Kg during the subsequent weeks (week 2 to 16), and administered intravenously over a 1-2 hour period. The dose of ascorbic acid will be 1000 mg in 100 cc D5W or normal saline solution (NaCl 0.9 %) (protected from light and air) administered as an IV infusion over 15 to 30 minutes. The dosing solution is not to be mixed with any alkaline solution.
Ospedale SS Antonio, Biagio e Cesare Arrigo
Alessandria, Italy
Ospedale Cardinal Massaia
Asti, Italy
Spedali Civili
Brescia, Italy
TO evaluate the erythroid response rate (major), according to the International Working Group (IWG) criteria (42) after four months of treatment with the association of ATO and ascorbic acid.
Time frame: 16 mounths
To evaluate platelets and granulocyte response according to the International Working Group (IWG) criteria (42) after four months of treatment with the association of ATO and ascorbic acid
Time frame: 16 mounths
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Ospedale Maggiore
Chieri, Italy
Ospedale civico di Chivasso
Chivasso (TO), Italy
Ospedale Santa Croce e Carle
Cuneo, Italy
AOS San Gerardo de' Tintori
Monza, Italy
Università Avogadro Divisione di Ematologia
Novara, Italy
Ospedale San Luigi Gonzaga Divisione di Ematologia
Orbassano (TO), Italy
Azienda Ospedaliera Perugia
Perugia, Italy
...and 3 more locations