Clinical trial NCT01956799: Identification of Mechanism in the Erythroid Response in Patients With Myelodysplasia Undergoing Chelation Therapy
Official title: Identification of Mechanisms in the Erythroid Response in Patients With Myelodysplasia Undergoing Chelation Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelodysplasia
Myelofibrosis
Aplastic Anemia
Keywords: MDS
PMF
CMML
AA
Lead sponsor: Fondazione Italiana Sindromi Mielodisplastiche-ETS
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of Myelodysplasia, myelofibrosis or aplastic anemia undergoing chelation therapy with deferasirox or deferoxamine

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.


Eligibility criteria: 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

Primary outcomes:
measure: To assess the molecular mechanism underlying the erythroid response
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Ematologia, AO SS. Antonio e Biagio
state: AL
city: Ancona
country: Italy
facility: Clinica di Ematologia, AOU Ospedale di Torrette
state: AN
city: Bari
country: Italy
facility: Ematologia con trapianto, AOU Policlinico di Bari
state: BA
city: Bologna
country: Italy
facility: Istituto di Ematologia e Oncologia Medica, Policlinico S.Orsola
state: BO
city: Brescia
country: Italy
facility: Ematologia, Spedali Civili
state: BS
city: Cuneo
country: Italy
facility: Struttura complessa di Ematologia, ASO S.Croce e Carle
state: CN
city: Firenze
country: Italy
facility: Cattedra di Ematologia Policlino Careggi
state: FI
city: Genova
country: Italy
facility: Clinica Ematologica, Università di Genova
state: GE
city: Genova
country: Italy
facility: U.O. Clinica Medicina Interna, IRCCS San Martino IST
state: GE
city: Piacenza
country: Italy
facility: UO Ematologia e CTMO, Ospedale Civile G. da Saliceto
state: PC
city: Padova
country: Italy
facility: Ematologia, Università di Padova
state: PD
city: Parma
country: Italy
facility: Struttura Cattedra di Ematologia e CTMO, AOU di Parma
state: PR
city: Rionero in Vulture
country: Italy
facility: Ematologia e Centro Trapianti, Centro di Riferimento Oncologico della Basilicata
state: PZ
city: Orbassano
country: Italy
facility: Medicina Interna II Divisione di Ematologia, Ospedale S. Luigi Gonzaga
state: TO
city: Torino
country: Italy
facility: Ematologia 2, AOU Città della Salute e della Scienza
state: TO
city: Torino
country: Italy
facility: S.C.D.U. Ematologia e Terapie cellulari, Ospedale Mauriziano
state: TO
city: Roma
country: Italy
facility: UOC Ematologia, Ospedale S.Eugenio
city: Roma
country: Italy
facility: Policlinico A.Gemelli
city: Roma
country: Italy
facility: UOC Ematologia, AO S. Giovanni Addolorata
city: Roma
country: Italy
facility: Ematologia, AO S. Andrea
Study officials:
affiliation: AOU S. Luigi Gonzaga, Regione Gonzole 10, 10043 Orbassano (TO)
name: Daniela Cilloni, MD
role: PRINCIPAL_INVESTIGATOR
References: