Status:
TERMINATED
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
Lead Sponsor:
Fondazione Italiana Sindromi Mielodisplastiche-ETS
Collaborating Sponsors:
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 Differentiatin...
Eligibility Criteria
Inclusion
- Age higher than 18;
- 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).
- Low or intermediate-1 IPSS (appendix).
- Hb \< 11g/dl.
- rEPO serum level \< 500mU/L.
- Women in menopause from at least one year.
- Informed consent
Exclusion
- Myelodisplastic syndrome with excess of blasts (RAEB).
- IPSS score intermediate-2 or high (appendix).
- 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.
- Renal failure with creatininemia value greater than 3 times the normal limit.
- 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.
- Presence of second tumor or other serious pathology with life expectancy lower than one year.
- Presence of neurologic or psychiatric pathologies that make the patient unreliable in the acquisition of drugs.
- Allergy/intolerance known to use drugs.
- Pregnant women.
- Women of childbearing age or in menopause from less than one year.
- Age \< 18 years old.
- HIV positive.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT00804050
Start Date
March 1 2007
End Date
March 1 2010
Last Update
June 28 2011
Active Locations (18)
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1
Ospedale SS. Antonio, Biagio e Cesare Arrigo
Alessandria, Italy
2
Ospedale degli Infermi
Biella, Italy
3
Spedali civili
Brescia, Italy
4
Ospedale Santo Spirito
Casale (AL), Italy