NCT00804050 is a Phase 3 clinical trial of infusion A: rEPO in Myelodysplastic Syndromes, sponsored by Fondazione Italiana Sindromi Mielodisplastiche-ETS.

Who is sponsoring NCT00804050?

NCT00804050 is sponsored by Fondazione Italiana Sindromi Mielodisplastiche-ETS.

What drugs are being tested in NCT00804050?

Interventions in NCT00804050: infusion A: rEPO, B Infusion rEPO combined with vitamins pills.

What condition does NCT00804050 study?

NCT00804050 studies Myelodysplastic Syndromes.

Is NCT00804050 still recruiting?

NCT00804050 is currently terminated. Last updated 27 June 2011.

Last reviewed 2011-06-27 · How we verify

NCT00804050

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 3 Last updated 27 June 2011

What this trial tests

Phase 3 trial testing infusion A: rEPO in Myelodysplastic Syndromes in 184 participants. Terminated before completion.

Timeline

1 March 2007

Primary endpoint
1 March 2009

1 March 2010

Quick facts

Lead sponsor	Fondazione Italiana Sindromi Mielodisplastiche-ETS
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	184
Start date	1 March 2007
Primary completion	1 March 2009
Estimated completion	1 March 2010
Sites	18 locations across Italy

Drugs / interventions tested

infusion A: rEPO — full drug profile →
B Infusion rEPO combined with vitamins pills — full drug profile →

Conditions studied

Myelodysplastic Syndromes — all drugs for Myelodysplastic Syndromes →

Sponsor

Fondazione Italiana Sindromi Mielodisplastiche-ETS — full company profile →

Who can join

18 and older, any sex, with Myelodysplastic Syndromes. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

The Potential of Vitamin D-Regulated Intracellular Signaling Pathways as Targets for Myeloid Leukemia Therapy.
Gocek E, Studzinski GP. · · 2015 · cited 14× · PMID 26239344 · DOI 10.3390/jcm4040504

Verify or expand the search:

Other recruiting trials for Myelodysplastic Syndromes

Currently open trials in the same condition.

NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
NCT06303193 — Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or · Phase 1, PHASE2 · recruiting
NCT07071155 — Momelotinib in Combination With Hypomethylating Agent for Chronic Phase Myelodysplastic Syndromes/Myeloproliferative Ove · EARLY_PHASE1 · recruiting
NCT07283900 — Ascorbate in Myelodysplastic Syndrome · Phase 2 · recruiting
NCT06487247 — HEME Home Transfusion Program · NA · recruiting

Other Fondazione Italiana Sindromi Mielodisplastiche-ETS trials

Trials by the same sponsor.

NCT05520749 — Efficacy and Safety of Luspatercept: a Study by Fondazione Italiana Sindromi Mielodisplastiche · completed
NCT04212390 — Personalized Medicine Program on Myelodysplastic Syndromes: Characterization of the Patient's Genome for Clinical Decisi · completed
NCT03920657 — Early and Low Dose Deferasirox (3.5 mg/kg FCT) to Suppress NTBI and LPI as Early Intervention to Prevent Tissue Iron Ove · Phase 2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00804050 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fondazione Italiana Sindromi Mielodisplastiche-ETS
Last refreshed: 27 June 2011

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00804050.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing