NCT01956799

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2013

Longer than P75 for all trials

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

5.2 years

First QC Date

September 30, 2013

Last Update Submit

February 14, 2023

Conditions

MyelodysplasiaMyelofibrosisAplastic Anemia

Keywords

MDSPMFCMMLAA

Outcome Measures

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

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Ematologia, AO SS. Antonio e Biagio

Alessandria, AL, 15121, Italy

Location

Clinica di Ematologia, AOU Ospedale di Torrette

Ancona, AN, 60020, Italy

Location

Ematologia con trapianto, AOU Policlinico di Bari

Bari, BA, 70124, Italy

Location

Istituto di Ematologia e Oncologia Medica, Policlinico S.Orsola

Bologna, BO, 40138, Italy

Location

Ematologia, Spedali Civili

Brescia, BS, 25123, Italy

Location

Struttura complessa di Ematologia, ASO S.Croce e Carle

Cuneo, CN, 12100, Italy

Location

Cattedra di Ematologia Policlino Careggi

Florence, FI, 50134, Italy

Location

Clinica Ematologica, Università di Genova

Genova, GE, 16132, Italy

Location

U.O. Clinica Medicina Interna, IRCCS San Martino IST

Genova, GE, 16132, Italy

Location

UO Ematologia e CTMO, Ospedale Civile G. da Saliceto

Piacenza, PC, 29121, Italy

Location

Ematologia, Università di Padova

Padua, PD, 35128, Italy

Location

Struttura Cattedra di Ematologia e CTMO, AOU di Parma

Parma, PR, 43100, Italy

Location

Ematologia e Centro Trapianti, Centro di Riferimento Oncologico della Basilicata

Rionero in Vulture, PZ, 85028, Italy

Location

Medicina Interna II Divisione di Ematologia, Ospedale S. Luigi Gonzaga

Orbassano, TO, 10043, Italy

Location

Ematologia 2, AOU Città della Salute e della Scienza

Torino, TO, 10126, Italy

Location

S.C.D.U. Ematologia e Terapie cellulari, Ospedale Mauriziano

Torino, TO, 10128, Italy

Location

UOC Ematologia, Ospedale S.Eugenio

Roma, 00144, Italy

Location

Policlinico A.Gemelli

Roma, 00168, Italy

Location

UOC Ematologia, AO S. Giovanni Addolorata

Roma, 00184, Italy

Location

Ematologia, AO S. Andrea

Roma, 00189, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood and bone marrow

MeSH Terms

Conditions

Anemia, Refractory, with Excess of BlastsPrimary MyelofibrosisAnemia, Aplastic

Condition Hierarchy (Ancestors)

Anemia, RefractoryAnemiaHematologic DiseasesHemic and Lymphatic DiseasesMyelodysplastic SyndromesBone Marrow DiseasesMyeloproliferative DisordersBone Marrow Failure Disorders

Study Officials

  • Daniela Cilloni, MD

    AOU S. Luigi Gonzaga, Regione Gonzole 10, 10043 Orbassano (TO)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2013

First Posted

October 8, 2013

Study Start

May 1, 2013

Primary Completion

July 1, 2018

Study Completion

December 1, 2019

Last Updated

February 15, 2023

Record last verified: 2023-02

Locations

IT(20)