Identification of Mechanism in the Erythroid Response in Patients With Myelodysplasia Undergoing Chelation Therapy (BIOFER12)

February 14, 2023 updated by: Fondazione Italiana Sindromi Mielodisplastiche-ETS

Identification of Mechanisms in the Erythroid Response in Patients With Myelodysplasia Undergoing Chelation Therapy

The study aims to evaluate the molecular mechanism underlying the erythroid response observed in some patients with myelodysplasia, myelofibrosis and aplastic anemia treated with Deferasirox or Deferoxamina.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00144
        • UOC Ematologia, Ospedale S.Eugenio
      • Roma, Italy, 00168
        • Policlinico A.Gemelli
      • Roma, Italy, 00184
        • UOC Ematologia, AO S. Giovanni Addolorata
      • Roma, Italy, 00189
        • Ematologia, AO S. Andrea
    • AL
      • Alessandria, AL, Italy, 15121
        • Ematologia, AO SS. Antonio e Biagio
    • AN
      • Ancona, AN, Italy, 60020
        • Clinica di Ematologia, AOU Ospedale di Torrette
    • BA
      • Bari, BA, Italy, 70124
        • Ematologia con trapianto, AOU Policlinico di Bari
    • BO
      • Bologna, BO, Italy, 40138
        • Istituto di Ematologia e Oncologia Medica, Policlinico S.Orsola
    • BS
      • Brescia, BS, Italy, 25123
        • Ematologia, Spedali Civili
    • CN
      • Cuneo, CN, Italy, 12100
        • Struttura complessa di Ematologia, ASO S.Croce e Carle
    • FI
      • Firenze, FI, Italy, 50134
        • Cattedra di Ematologia Policlino Careggi
    • GE
      • Genova, GE, Italy, 16132
        • Clinica Ematologica, Università di Genova
      • Genova, GE, Italy, 16132
        • U.O. Clinica Medicina Interna, IRCCS San Martino IST
    • PC
      • Piacenza, PC, Italy, 29121
        • UO Ematologia e CTMO, Ospedale Civile G. da Saliceto
    • PD
      • Padova, PD, Italy, 35128
        • Ematologia, Università di Padova
    • PR
      • Parma, PR, Italy, 43100
        • Struttura Cattedra di Ematologia e CTMO, AOU di Parma
    • PZ
      • Rionero in Vulture, PZ, Italy, 85028
        • Ematologia e Centro Trapianti, Centro di Riferimento Oncologico della Basilicata
    • TO
      • Orbassano, TO, Italy, 10043
        • Medicina Interna II Divisione di Ematologia, Ospedale S. Luigi Gonzaga
      • Torino, TO, Italy, 10126
        • Ematologia 2, AOU Città della Salute e della Scienza
      • Torino, TO, Italy, 10128
        • S.C.D.U. Ematologia e Terapie cellulari, Ospedale Mauriziano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with diagnosis of Myelodysplasia, myelofibrosis or aplastic anemia undergoing chelation therapy with deferasirox or deferoxamine

Description

Inclusion Criteria:

  1. Patients aged 18 and older
  2. Diagnosis of Myelodysplasia, myelofibrosis or aplastic anemia
  3. transfusion-dependent anemia undergoing chelation therapy with deferasirox or deferoxamine

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the molecular mechanism underlying the erythroid response
Time Frame: 12 months
The primary outcome is to evaluate the molecular mechanism underlying the erythroid response (hemogoblin increase and reduction or elimination of trasfusion dependence) observed in some patients with myelodysplasia, myelofibrosis and aplastic anemia treated with Deferasirox or Deferoxamina
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Italiana Sindromi Mielodisplastiche-ETS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

September 30, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (Estimate)

October 8, 2013

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FISM-BIOFER12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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