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

Sponsor
Fondazione Italiana Sindromi Mielodisplastiche-ETS (Other)
Overall Status
Unknown status
CT.gov ID
NCT01956799
Collaborator
(none)
100
Enrollment
20
Locations
79
Duration (Months)
5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Identification of Mechanisms in the Erythroid Response in Patients With Myelodysplasia Undergoing Chelation Therapy
    Study Start Date :
    May 1, 2013
    Actual Primary Completion Date :
    Jul 1, 2018
    Anticipated Study Completion Date :
    Dec 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. To assess the molecular mechanism underlying the erythroid response [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Fondazione Italiana Sindromi Mielodisplastiche-ETS

    Investigators

    • Principal Investigator: Daniela Cilloni, MD, AOU S. Luigi Gonzaga, Regione Gonzole 10, 10043 Orbassano (TO)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fondazione Italiana Sindromi Mielodisplastiche-ETS
    ClinicalTrials.gov Identifier:
    NCT01956799
    Other Study ID Numbers:
    • FISM-BIOFER12
    First Posted:
    Oct 8, 2013
    Last Update Posted:
    Jul 30, 2019
    Last Verified:
    Jul 1, 2019
    Keywords provided by Fondazione Italiana Sindromi Mielodisplastiche-ETS
    MDS
    PMF
    CMML
    AA
    Additional relevant MeSH terms:
    Preleukemia
    Anemia, Aplastic
    Myelodysplastic Syndromes

    Study Results

    No Results Posted as of Jul 30, 2019