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

Phase 3

Terminated

• Conditions: Myelodysplastic Syndromes
• Interventions: Drug: B Infusion rEPO combined with vitamins pills

• Registration Number: NCT00804050
• Lead Sponsor: Fondazione Italiana Sindromi Mielodisplastiche-ETS

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 Differentiating Therapy With Acid 13-Cis-Retinoic and Dihydroxyvitamin D3 in Myelodysplastic Syndromes Without Excess of Blasts

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2008-12-05
• Study First Submitted QC: 2008-12-05
• Study First Posted: 2008-12-08
• Primary Completion: 2009-03
• Study Completion: 2010-03
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-27
• Last Update Posted: 2011-06-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

1. Age higher than 18;
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

1. Myelodisplastic syndrome with excess of blasts (RAEB).
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infusion B combined r-EPO	B Infusion rEPO combined with vitamins pills	rEPO in association with acid 13-cis-retinoic acid and Dihydroxyvitamin D3 for 4 mounths consequently

Primary Outcome Measures

Name	Time	Method
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	After 8 months

Secondary Outcome Measures

Name	Time	Method
To evaluate the quality of life improvement due to therapy.	8 mounths
To evaluate the percentage of leukemic progression.	20 mounths
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.	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.	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.	20 mounths

Trial Locations

Locations (18)

Ospedale San Gerardo; 🇮🇹 Monza (MI), Italy

Istituto clinico Humanitas; 🇮🇹 Rozzano (MI), Italy

Ospedale San Giovanni Battista Molinette; 🇮🇹 Torino, Italy

Ospedale Civile; 🇮🇹 Ovada (AL), Italy

Ospedale civile; 🇮🇹 Ivrea (TO), Italy

Ospedale Maggiore della Carità; 🇮🇹 Novara, Italy

Ospedale SS. Antonio, Biagio e Cesare Arrigo; 🇮🇹 Alessandria, Italy

Ospedale degli Infermi; 🇮🇹 Biella, Italy

Ospedale Santo Spirito; 🇮🇹 Casale (AL), Italy

Spedali civili; 🇮🇹 Brescia, 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 Sant'Andrea; 🇮🇹 Vercelli, Italy

Ospedale San Bortolo; 🇮🇹 Vicenza, Italy

Ospedale Cardinale Panico; 🇮🇹 Tricase (LE), Italy