Multicentric Study Comparison Between Erythropoietin and Erythropoietin Associated to Differentiating Therapy With Acid 13-cis-retinoic and Dihydroxyvitamin D3 in Myelodysplastic Syndromes Without Excess of Blasts
NCT ID: NCT00804050
Last Updated: 2011-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
184 participants
INTERVENTIONAL
2007-03-31
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Infusion A: rEPO
rEPO for 4 mounths consequently
infusion A: rEPO
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.
Infusion B combined r-EPO
rEPO in association with acid 13-cis-retinoic acid and Dihydroxyvitamin D3 for 4 mounths consequently
B Infusion rEPO combined with vitamins pills
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
Interventions
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infusion A: rEPO
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.
B Infusion rEPO combined with vitamins pills
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
Eligibility Criteria
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Inclusion Criteria
2. Confirmed diagnosis by osseous biopsy and bone marrow cyto-morphologic counts of blast cells, of Myelodysplastic syndrome without excess of blasts: "refractary anemia", "refractary anemia with rings sideroblasts", "refractary citopenya with multilineage dysplasia", " refractary citopenya with multilineage dysplasia and rings sideroblasts" or "5q-syndrome" without excess of blasts based on WHO classification (appendix).
3. Low or intermediate-1 IPSS (appendix).
4. Hb \< 11g/dl.
5. rEPO serum level \< 500mU/L.
6. Women in menopause from at least one year.
7. Informed consent
Exclusion Criteria
2. IPSS score intermediate-2 or high (appendix).
3. Forecasted allogeneic bone marrow transplant within 1 year after diagnosis(patients younger than 60 years, transfusion dependents or with serious leuko/thrombocytopenia and HLA compatible family donor).Considering the time needed to perform this procedure, the indication of a transplant from non-consanguineous donor has no contraindication to the inclusion in this protocol of the response to rEPO therapy ± differentiating therapy.
4. Renal failure with creatininemia value greater than 3 times the normal limit.
5. Chronic hepatophaty with bilirubinemia value greater than 3 times the normal limit and/or AST or ALT or ALP values greater than 5 times the normal limit.
6. Presence of second tumor or other serious pathology with life expectancy lower than one year.
7. Presence of neurologic or psychiatric pathologies that make the patient unreliable in the acquisition of drugs.
8. Allergy/intolerance known to use drugs.
9. Pregnant women.
10. Women of childbearing age or in menopause from less than one year.
11. Age \< 18 years old.
12. HIV positive.
18 Years
ALL
No
Sponsors
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Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
OTHER
Fondazione Italiana Sindromi Mielodisplastiche-ETS
OTHER
Responsible Party
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University of Torino - Ospedale S Giovanni Battista
Principal Investigators
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Dario Ferrero, MD
Role: STUDY_DIRECTOR
University of Torino - Ospedale San Giovanni Battista
Alessandro Levis, MD
Role: STUDY_DIRECTOR
Ospedale SS. Antonio, Biagio e Cesare Arrigo
Locations
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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
Ospedale San Gerardo
Monza (MI), , Italy
Ospedale Maggiore della Carità
Novara, , Italy
Ospedale Civile
Ovada (AL), , Italy
Istituto clinico Humanitas
Rozzano (MI), , Italy
Ospedale San Giovanni Battista Molinette
Torino, , Italy
Ospedale Cardinale Panico
Tricase (LE), , Italy
Ospedale Sant'Andrea
Vercelli, , Italy
Ospedale San Bortolo
Vicenza, , Italy
Countries
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Other Identifiers
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2006-006482-16
Identifier Type: -
Identifier Source: secondary_id
EPO2006-AISSM04
Identifier Type: -
Identifier Source: org_study_id
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