MyelodysplasiaBIOFER12NCT01956799
Identification of Mechanism in the Erythroid Response in Patients With Myelodysplasia Undergoing Chelation Therapy
An observational study of Myelodysplasia and Myelofibrosis, run by Fondazione Italiana Sindromi Mielodisplastiche-ETS at 20 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplasia, Myelofibrosis, Aplastic Anemia
- How many people
- 100 participants
- Where
- 20 sitesItaly
- Study dates
- May 2013to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diagnosis of Myelodysplasia, myelofibrosis or aplastic anemia undergoing chelation therapy with deferasirox or deferoxamine
Who may be able to join
- Patients aged 18 and older
- Diagnosis of Myelodysplasia, myelofibrosis or aplastic anemia
- transfusion-dependent anemia undergoing chelation therapy with deferasirox or deferoxamine
Who cannot join
- none
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Italy20 sites
Ematologia, AO SS. Antonio e Biagio
Alessandria, AL, 15121
Clinica di Ematologia, AOU Ospedale di Torrette
Ancona, AN, 60020
Ematologia con trapianto, AOU Policlinico di Bari
Bari, BA, 70124
Istituto di Ematologia e Oncologia Medica, Policlinico S.Orsola
Bologna, BO, 40138
Ematologia, Spedali Civili
Brescia, BS, 25123
Struttura complessa di Ematologia, ASO S.Croce e Carle
Cuneo, CN, 12100
Cattedra di Ematologia Policlino Careggi
Florence, FI, 50134
Clinica Ematologica, Università di Genova
Genova, GE, 16132
U.O. Clinica Medicina Interna, IRCCS San Martino IST
Genova, GE, 16132
Medicina Interna II Divisione di Ematologia, Ospedale S. Luigi Gonzaga
Orbassano, TO, 10043
Ematologia, Università di Padova
Padova, PD, 35128
Struttura Cattedra di Ematologia e CTMO, AOU di Parma
Parma, PR, 43100
UO Ematologia e CTMO, Ospedale Civile G. da Saliceto
Piacenza, PC, 29121
Ematologia e Centro Trapianti, Centro di Riferimento Oncologico della Basilicata
Rionero in Vulture, PZ, 85028
UOC Ematologia, Ospedale S.Eugenio
Roma, 00144
Policlinico A.Gemelli
Roma, 00168
UOC Ematologia, AO S. Giovanni Addolorata
Roma, 00184
Ematologia, AO S. Andrea
Roma, 00189
Ematologia 2, AOU Città della Salute e della Scienza
Torino, TO, 10126
S.C.D.U. Ematologia e Terapie cellulari, Ospedale Mauriziano
Torino, TO, 10128
About this study
Official title: Identification of Mechanisms in the Erythroid Response in Patients With Myelodysplasia Undergoing Chelation Therapy
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.
- Conditions
- Myelodysplasia, Myelofibrosis, Aplastic Anemia
- Keywords
- MDS, PMF, CMML, AA
- Medical subject headings
- Anemia, Refractory, with Excess of Blasts, Primary Myelofibrosis, Anemia, Aplastic
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2018
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelodysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Sindromi Mielodisplastiche-ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniela Cilloni, MD, Principal investigator, AOU S. Luigi Gonzaga, Regione Gonzole 10, 10043 Orbassano (TO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956799
- Sponsor's protocol ID
- FISM-BIOFER12
- Acronym
- BIOFER12
- Status last verified
- Feb 2023
- First submitted
- 30 Sep 2013
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Mechanisms in the Erythroid Response in Patients With Myelodysplasia Undergoing Chelation Therapy
- ClinicalTrials.gov ID
- NCT01956799
- Acronym / sponsor ID
- BIOFER12 / FISM-BIOFER12
- Conditions
- Myelodysplasia, Myelofibrosis, Aplastic Anemia
- Keywords
- MDS, PMF, CMML, AA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Italiana Sindromi Mielodisplastiche-ETSUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jul 2018 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of Myelodysplasia, myelofibrosis or aplastic anemia undergoing chelation therapy with deferasirox or deferoxamine
Key inclusion criteria (3 listed)
- Patients aged 18 and older
- Diagnosis of Myelodysplasia, myelofibrosis or aplastic anemia
- transfusion-dependent anemia undergoing chelation therapy with deferasirox or deferoxamine
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the molecular mechanism underlying the erythroid response
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniela Cilloni, MD principal investigator
AOU S. Luigi Gonzaga, Regione Gonzole 10, 10043 Orbassano (TO)
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplasia and Myelofibrosis, run by Fondazione Italiana Sindromi Mielodisplastiche-ETS at 20 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the molecular mechanism underlying the erythroid response (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.