Myelodysplastic Syndrome
Conditions
Keywords
IRON, oxidative stress, MDS
Brief summary
Certain percentage of MDS patients develop iron overload. Iron is known to participate in intracellular reactions that generate free radicals, inducing oxidative stress and apoptosis, which was found to be increased in MDS patients and consequently resulted in ineffective hematopoiesis. The aim of this study is to evaluate the antioxidant effect of the oral iron chelator Deferasirox -Exjade in low risk MDS patients with iron over load by evaluating changes in several oxidative stress parameters Certain percentage of MDS patients develop iron overload.
Interventions
DRUGExjade
Sponsors
Hadassah Medical Organization
Tel-Aviv Sourasky Medical Center
Sheba Medical Center
Soroka University Medical Center
Wolfson Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with myelodysplastic syndrome with an IPSS score being Intermediate-1 or low. * Patients who already received ≥20 unit (100 mL/kg) of packed red blood cells and showing evidence of iron overload (serum ferritin \>1000 µg/L). * Patients post stem cells transplantation with disease recurrence with MDS IPSS score low or intermediate 1. * Patients who have given consent personally in writing
Exclusion criteria
* Patients with myelodysplastic syndrome with an IPSS score being Intermediate-2 or High. * Patients with serum creatinine \>2.0 x ULN * Patients with ALT(SGPT) levels \> 5 x ULN * Significant proteinuria as indicated by a urinary protein/creatinine ratio \>0.5 mg/mg in a non-first void urine sample on two assessments during the screening period. * History of HIV positive test result. When there are any signs or symptoms indicative of the disease even if the diagnosis is not made, additional test should be conducted. * History of clinical or laboratory evidence of active Hepatitis B or Hepatitis C (HBsAg in the absence of HBsAb OR HCV Ab positive with HCV RNA positive and ALT above the normal range) * Patients with systemic uncontrolled hypertension * Patients with unstable cardiac disease not controlled by standard medical therapy * Systemic disease (cardiovascular, renal, hepatic, etc.) which would prevent study treatment * Pregnancy or breast feeding. Female of child-bearing potential should conduct contraception during the clinical trial. * Patients treated with systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days * Other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drug * Patients being considered by the investigator potentially unreliable and/or not cooperative with regard to the study protocol * History of hypersensitivity to any of the study drug or excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the antioxidative effect of Exjade therapy in MDS patients | one year |
| with iron over load by evaluating oxidative stress parameters | one year |
| pre and post treatment | one year |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of Exjade over the treatment period. | one year |
| To analyze iron overload after Exjade treatment period. | one year |
| To evaluate transfusion requirements. | one year |
| To confirm the value of LPI, LIP, and Hepcidin as a marker for accurate monitoring of chelation therapy in MDS patients with iron over load. | one year |
Countries
Israel
Outcome results
None listed