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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

NCT00804050 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2011-06-28

No results posted yet for this study

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

Conditions

Interventions

DRUG

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.

DRUG

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

Sponsors & Collaborators

  • Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

    collaborator OTHER

  • Fondazione Italiana Sindromi Mielodisplastiche-ETS

    lead OTHER

Principal Investigators

  • Dario Ferrero, MD · University of Torino - Ospedale San Giovanni Battista

  • Alessandro Levis, MD · Ospedale SS. Antonio, Biagio e Cesare Arrigo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-03-31
Completion
2010-03-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00804050 on ClinicalTrials.gov