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NCT01956799 Clinical Trial

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

Myelofibrosis Clinical Trial

— BIOFER12  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01956799
Other study ID # FISM-BIOFER12
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2013
Est. completion date December 2019

Study information
Verified date February 2023
Source Fondazione Italiana Sindromi Mielodisplastiche-ETS
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 2019
Est. primary completion date July 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

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

Sponsors (1)
Lead Sponsor Collaborator
Fondazione Italiana Sindromi Mielodisplastiche-ETS

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary To assess the molecular mechanism underlying the erythroid response 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
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