Identification of Mechanisms in the Erythroid Response in Patients With Myelodysplasia Undergoing Chelation Therapy
Identification of Mechanism in the Erythroid Response in Patients With Myelodysplasia Undergoing Chelation Therapy
Sponsors
Source
Fondazione Italiana Sindromi Mielodisplastiche Onlus
Oversight Info
Has Dmc
No
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.
Overall Status
Active, not recruiting
Start Date
2013-05-01
Completion Date
2018-12-01
Primary Completion Date
2018-07-01
Study Type
Observational
Primary Outcome
Measure |
Time Frame |
|
To assess the molecular mechanism underlying the erythroid response |
12 months |
Enrollment
100
Conditions
Eligibility
Study Pop
Patients with diagnosis of Myelodysplasia, myelofibrosis or aplastic anemia undergoing
chelation therapy with deferasirox or deferoxamine
Sampling Method
Non-Probability Sample
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:
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Daniela Cilloni, MD |
Principal Investigator |
AOU S. Luigi Gonzaga, Regione Gonzole 10, 10043 Orbassano (TO) |
Location
Facility |
|
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 |
Location Countries
Country
Italy
Verification Date
2018-06-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Firstreceived Results Date
N/A
Biospec Retention
Samples With DNA
Biospec Descr
Peripheral blood and bone marrow
Acronym
BIOFER12
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Cohort
Time Perspective
Prospective
Study First Submitted
September 30, 2013
Study First Submitted Qc
October 7, 2013
Study First Posted
October 8, 2013
Last Update Submitted
July 31, 2018
Last Update Submitted Qc
July 31, 2018
Last Update Posted
August 1, 2018
ClinicalTrials.gov processed this data on August 31, 2018
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.