This is a prospective, randomized multicenter phase III clinical trial designed to evaluate the safety and activity of comparison between Erythropoietin and Erythropoietin Associated to Differentiating Therapy With Acid 13-Cis-Retinoic and Dihydroxyvitamin D3 in Myelodysplastic Syndromes Without Excess of Blasts
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
184
rEPO 40.000 unit/week for 4 mounths, then patients who have obtained an erythroid response, will continue for another 4 months with therapy rEPO. Patients who have not obtained an erythroid response, will increase the dose rEPO to 80,000 units per week for an additional 4 months.
rEPO 40.000 unit/week plus acid 13 cis-retinoic (20 mg/die) plus Dihydroxyvitamin D3 (1 μg os/die), for 4 mounths. Patients who have obtained an erythroid response will continue for another 4 months with the same therapy. Patients who have not obtained an erythroid will increase the dose of rEPO to 80,000 units per week for additional 4 months.Patients also will continue with the same doses of acid 13-cis-retinoic acid and Dihydroxyvitamin D3
Ospedale SS. Antonio, Biagio e Cesare Arrigo
Alessandria, Italy
Ospedale degli Infermi
Biella, Italy
Spedali civili
Brescia, Italy
Ospedale Santo Spirito
Casale (AL), Italy
Ospedale Maggiore
Chieri (TO), Italy
Policlinico dell'Annunziata
Cosenza, Italy
Ospedale Santa Croce e Carle
Cuneo, Italy
Ospedale Santa Croce
Fano (PU), Italy
Ospedale San Martino
Genova, Italy
Ospedale civile
Ivrea (TO), Italy
...and 8 more locations
study of comparison between standard theraphy rEPO (40.000unit/week) and association therapy between rEPO (40.000unit/week)plus Acid 13-Cis-Retinoic and Dihydroxyvitamin D3
Time frame: After 8 months
TO evaluate if,the patients without eritroyd response at the end of the 4° month of therapy, the increase of dose of rEPO to 80.000 U / week allows to get an increase of valued response at the end of the 8° month.
Time frame: 8 months
To evaluate if there is a difference of duration in the eritroyd response with standard therapy rEPO in comparison with association therapy rEPO plus Acid 13-Cis-Retinoic and Dihydroxyvitamin D3.
Time frame: 20 mounths
To evaluate the existing relationships among eritroyd response and clinical-biological parameters at baseline of anemia, subclass of MDS, silky dosing of the EPO etc.
Time frame: 20 mounths
To evaluate the quality of life improvement due to therapy.
Time frame: 8 mounths
To evaluate the percentage of leukemic progression.
Time frame: 20 mounths
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