CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 28 enrolled
Drug / intervention
Deferasirox DFX, DT +2 moredrug
Likely dose
Deferasirox DFX, DT 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01868477
NCT01868477Phase 2Completed
CompareCT.gov

An Open-label, Phase II, Randomized, Pilot Study to Assess the Effect in Term of Erythroid Improvement of Deferasirox Combined With Erythropoietin Compared to Erythropoietin Alone in Patients With low-and Int-1-risk Myelodysplastic Syndrome.

Novartis Pharmaceuticals·interventional·Posted Jun 4, 2013·Updated Oct 31, 2018

In Brief

A Phase 2 clinical trial evaluating Deferasirox DFX, DT, Erythropoietin alpha, and 1 other intervention for Low and Int 1-risk Myelodysplastic Syndrome. Completed, enrolled 28 participants across 30 sites in 10 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow and Int 1-risk Myelodysplastic Syndrome
CountriesAlgeria, Argentina, Canada, China, Germany, Italy, South Korea, Spain, Sweden, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 4, 2013
Enrollment StartJan 28, 2014
Primary CompletionMar 22, 2017
Study CompletionApr 5, 2017
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 13.1 years ago

Interventions

Deferasirox DFX, DTdrug

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

Erythropoietin alphadrug

Deferasirox DFX, FCTdrug

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