Evaluation the Effect of Exjade on Oxidative Stress in Low Risk Myelodysplastic Syndrome Patients With Iron Over Load

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wolfson Medical Center
• Collaborators: Hadassah Medical Organization; Sheba Medical Center; Soroka University Medical Center; Tel-Aviv Sourasky Medical Center
• Treatments: Deferasirox

Criteria

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