Contact information
Type
Scientific
Primary contact
Dr Pilar Giraldo Castellano
ORCID ID
Contact details
Servicio de Hematología
Hospital Universitario Miguel Servet
Paseo Isabel La Católica 1-3
Zaragoza
50009
Spain
+34 670285339
giraldo.p@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
TRA-158 (EC09/080)
Study information
Scientific title
A single-centre, prospective, randomised, phase III clinical study to evaluate the efficacy and safety indicators of two different iron chelators in patients with iron overload
Acronym
QuelaFer
Study hypothesis
The main aim of this study is to evaluate the efficacy of Deferasirox versus Deferoxamine in reducing serum ferritin levels and iron liver deposits in iron overload patients.
Excess iron in blood and tissues causes irreversible tissue damage. The removal of excess iron as response to treatment positively influences on the survival of patients with overload. Currently, there are two types of iron chelating agents authorised, each one with different route of administration (Deferoxamine-parenteral and Deferasirox-oral) but the superiority of one over another is not defined in relation to the intensity of the response, time to be reached or the severity and frequency of associated adverse effects or its impact on quality of life.
Ethics approval
Clinical Research Ethics Committee of Aragon (Comité Ético de Investigación Clínica de Aragón) (CEICA).
Ref: C.I. EC09/080 11/08/2010
Study design
Phase III single-centre prospective randomised clinical study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Haemosiderosis
Intervention
1. Group A: Deferasirox 20 mg/kg/day oral capsules for 4 months
2. Group B: Desferoxamine 30 mg/kg/day, slow Subcutaneous (SC) infusion administered over 8 hours by a portable infusion pump 3 times/week for 4 months
3. Patients from both groups will be followed for 1-month period.
4. The following tests should be performed:
4.1. Peripheral blood creatinine (weekly in the 1st month and then monthly), serum transaminases, bilirubin and alkaline phosphatase (on day 1 of treatment, every 2 weeks in the 1st month, then monthly, and at the end of treatment)
4.2. Serum ferritin (at screening, at baseline and at the beginning of each month of treatment)
4.3. Liver magnetic resonance imaging (MRI) and quantification of tissue iron (at screening visit and at the end of 4 months of treatment)
4.4. Computerised tomography (CT), CCL18 and proBNP activity (at screening, before the 2nd month of treatment and after treatment)
4.5. Eastern Cooperative Oncology Group (ECOG) performance status (at screening, and on day 1 of each new cycle of treatment)
4.6. Electrocardiogram (at screening and whenever the investigator deems it appropriate, SF36 quality of life questionnaire (at screening, before the 2nd month of treatment and after treatment).
Intervention type
Drug
Phase
Phase III
Drug names
1. Deferoxamine
2. Deferasirox
Primary outcome measures
Treatment efficacy was determined by measuring the serum ferritin at screening, at baseline and at the beginning of each month of treatment
Secondary outcome measures
1. Identify whether blood biomarkers of macrophage activation (chitotriosidase, CCL-18) are higher in patients with iron overload than in the population with normal serum ferritin levels stratified by age and sex and if they can be used as markers of response to chelation therapy
2. To study if the biomarkers concentration correlates with the serum ferritin level, liver MRI, cardiac function assessed by ultrasound and its own changes after 4-month treatment with iron chelators
3.To assess the quality of life of patients undergoing both these treatments
Overall trial start date
01/03/2011
Overall trial end date
30/09/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age ≥ 18 years
2. Diagnosis of myelodysplastic syndrome
3. Have received a hematopoietic stem cell transplantation in the last 6 months
4. Gaucher's disease diagnosis
5. Serum ferritin concentration >500 mcg/L
6. To not have received previous iron chelation therapy
7. No severe renal failure (creatinine clearance >30 ml/min/1.73 m2)
8. No severe liver failure (liver enzymes under twice the upper normal limit)
9. Life expectancy of at least 6 months
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
32
Participant exclusion criteria
1. To not accept to use reliable contraception throughout the study and during three months after cessation of treatment
2. Pregnancy or breast-feeding
3. History of cataracts or increasing risk of cataract formation
4. Severe renal failure (creatinine clearance <30 ml/min/1.73 m2)
5. Active chronic disease such as human immunodeficiency virus (HIV) or hepatitis B or C
6. To have received treatment with iron chelators in the last 6 months
7. Suspected or known hypersensitivity to the drug under study or any of the excipients
8. Dependence or current abuse of drugs or alcohol
9. Treatment with another investigational product in the last 6 months prior to baseline
Recruitment start date
01/03/2011
Recruitment end date
30/09/2012
Locations
Countries of recruitment
Spain
Trial participating centre
Servicio de Hematología
Zaragoza
50009
Spain
Sponsor information
Organisation
Aragon Institute of Health Sciences [Instituto Aragonés de Ciencias de la Salud] (Spain)
Sponsor details
c/o Esteban de Manuel Kenoy
Instituto Aragonés de Ciencias de la Salud
Avenida Gómez Laguna
25
Zaragoza
50009
Spain
emlopezh.iacs@aragon.es
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Aragon Institute of Health Sciences [Instituto Aragonés de Ciencias de la Salud] (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary