Comparison Between Erythropoietin and Erythropoietin Associated to Differentiating Therapy With Acid 13-cis-retinoic and Dihydroxyvitamin D3 in Myelodysplastic Syndromes Without Excess of Blasts

Fondazione Italiana Sindromi Mielodisplastiche-ETS18 sites in 1 country184 target enrollmentMarch 2007

ConditionsMyelodysplastic Syndromes

InterventionsB Infusion rEPO combined with vitamins pills

Drugsinfusion A: rEPO B Infusion rEPO combined with vitamins pills

Overview

Phase: Phase 3
Intervention: B Infusion rEPO combined with vitamins pills
Conditions: Myelodysplastic Syndromes
Sponsor: Fondazione Italiana Sindromi Mielodisplastiche-ETS
Enrollment: 184
Locations: 18
Primary Endpoint: 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
Status: Terminated
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

March 2007

End Date

March 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Fondazione Italiana Sindromi Mielodisplastiche-ETS

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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.

Arms & Interventions

Infusion B combined r-EPO

rEPO in association with acid 13-cis-retinoic acid and Dihydroxyvitamin D3 for 4 mounths consequently

Intervention: B Infusion rEPO combined with vitamins pills

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)