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Combination Study of Deferasirox and Erythropoietin in Patients With Low- and Int-1-risk Myelodysplastic Syndrome.

NCT01868477 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2018-10-31

Study results available
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Summary

The primary purpose of this trial was is to assess the effect of treatment with deferasirox combined with erythropoietin vs. erythropoietin alone on erythropoiesis in patients with low- and int-1-risk myelodysplastic syndrome. The addition of deferasirox to erythropoietin can lead to a potential synergism with the reduction of reactive oxygen species, through both the NF-kB pathway and the control of free toxic iron. This may create a better environment in the bone marrow for a better response with erythropoietin.

This study was designed to test in a prospective way the combination of deferasirox with erythropoietin in terms of their effect on hematopoiesis.

Conditions

  • Low and Int 1-risk Myelodysplastic Syndrome

Interventions

DRUG

Deferasirox DFX, DT

provided as dispersible tablets for oral use in 125 and 250, 500 mg

DRUG

Erythropoietin alpha

DRUG

Deferasirox DFX, FCT

provided as film-coated tablet for oral use in 90, 180, 360 mg strengths

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-28
Primary Completion
2017-03-22
Completion
2017-04-05

Countries

  • Algeria
  • Argentina
  • Canada
  • China
  • Germany
  • Italy
  • South Korea
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT01868477 on ClinicalTrials.gov