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CompletedNCT01956799BIOFER12Updated Feb 15, 2023

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

An observational study in Myelodysplasia, Myelofibrosis and Aplastic Anemia, sponsored by Fondazione Italiana Sindromi Mielodisplastiche-ETS. Completed at 20 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-15.

Sponsored by Fondazione Italiana Sindromi Mielodisplastiche-ETS · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Myelodysplasia
  • Myelofibrosis
  • Aplastic Anemia

Keywords

  • MDS
  • PMF
  • CMML
  • AA
03

In context

Preleukemia

1,317 studies on the registry are indexed under Preleukemia; 57 are open to participants now.

This study's planned enrollment of 100 is below the median of 114 across 116 observational studies indexed under Preleukemia.

Browse Preleukemia studies →

Lead sponsor

Fondazione Italiana Sindromi Mielodisplastiche-ETS is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • none
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 months

07

Study locations

20 sites
  • Ematologia, AO SS. Antonio e Biagio
    Alessandria, AL 15121, Italy
  • Clinica di Ematologia, AOU Ospedale di Torrette
    Ancona, AN 60020, Italy
  • Ematologia con trapianto, AOU Policlinico di Bari
    Bari, BA 70124, Italy
  • Istituto di Ematologia e Oncologia Medica, Policlinico S.Orsola
    Bologna, BO 40138, Italy
  • Ematologia, Spedali Civili
    Brescia, BS 25123, Italy
  • Struttura complessa di Ematologia, ASO S.Croce e Carle
    Cuneo, CN 12100, Italy
  • Cattedra di Ematologia Policlino Careggi
    Firenze, FI 50134, Italy
  • Clinica Ematologica, Università di Genova
    Genova, GE 16132, Italy
  • U.O. Clinica Medicina Interna, IRCCS San Martino IST
    Genova, GE 16132, Italy
  • UO Ematologia e CTMO, Ospedale Civile G. da Saliceto
    Piacenza, PC 29121, Italy
  • Ematologia, Università di Padova
    Padova, PD 35128, Italy
  • Struttura Cattedra di Ematologia e CTMO, AOU di Parma
    Parma, PR 43100, Italy
  • Ematologia e Centro Trapianti, Centro di Riferimento Oncologico della Basilicata
    Rionero in Vulture, PZ 85028, Italy
  • Medicina Interna II Divisione di Ematologia, Ospedale S. Luigi Gonzaga
    Orbassano, TO 10043, Italy
  • Ematologia 2, AOU Città della Salute e della Scienza
    Torino, TO 10126, Italy
  • S.C.D.U. Ematologia e Terapie cellulari, Ospedale Mauriziano
    Torino, TO 10128, Italy
  • UOC Ematologia, Ospedale S.Eugenio
    Roma, 00144, Italy
  • Policlinico A.Gemelli
    Roma, 00168, Italy
  • UOC Ematologia, AO S. Giovanni Addolorata
    Roma, 00184, Italy
  • Ematologia, AO S. Andrea
    Roma, 00189, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01956799
Lead sponsor
Fondazione Italiana Sindromi Mielodisplastiche-ETS
Responsible party
Sponsor
First posted
Oct 8, 2013
Start date
May 2013
Primary completion
Jul 2018
Completion
Dec 2019
Last update
Feb 15, 2023

Study contacts

Daniela Cilloni, MD
principal investigator · AOU S. Luigi Gonzaga, Regione Gonzole 10, 10043 Orbassano (TO)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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