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Biological Predictive Factors of Response to ESA in Low Risk MDS Patients

NCT03598582 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2018-07-26

No results posted yet for this study

Summary

In this trial, the investigators would like to understand why a small percentage of patients will be refractory to ESA (independently of International prognostic scoring system (IPSS) and % of blasts). In a retrospective study of the "Groupe Francophone des Myélodysplasies (GFM)" , the investigators showed that about 43% of patients are refractory or will relapse after initial response to ESA and it has been shown that these patients have a poorer survival. The investigators plan to give a 12-week treatment of Epoetin alfa or zeta in low risk MDS patients and measure different biological factors to predict response to ESA:

* evaluation by flow cytometry before and after treatment of the degree of dyserythropoiesis and dysgranulopoiesis which could explain the primary resistance or loss of response of a subset of patients,
* screening by molecular biology of predictive factors of response to ESA,
* Iron homeostasis will be measured via hepcidin, GDF-15 and ferritin levels.

Conditions

Interventions

DRUG

Epoetin Zeta

Patients received epoetin zeta (Retacrit®) 40000UI/week subcutaneously during 12 weeks. Response has been evaluated at 12 weeks according to IWG 2006 criteria. Patients with response continued on epoetin zeta. In non-responders, the patients have been excluded from the protocol.

Sponsors & Collaborators

  • Association pour la recherche sur les Affections Malignes en Immunologie Sanguine

    lead OTHER

Principal Investigators

  • Sophie PARK, MD, PHD · CHU Grenoble Alpes

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-01
Primary Completion
2017-05-01
Completion
2018-05-01

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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 NCT03598582 on ClinicalTrials.gov