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

Sponsor

Wolfson Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00452660

Collaborator

Hadassah Medical Organization (Other), Tel-Aviv Sourasky Medical Center (Other), Sheba Medical Center (Other), Soroka University Medical Center (Other)

Enrollment

Location

Arm

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndrome	Drug: Exjade	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase IV , Multicenter ,Open Label ,Non Comparative ,Investigator Initiated Study , Evaluating the Effect of Exjade on Oxidative Stress in Low Risk Myelodysplastic Syndrome Patients With Iron Over Load

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

Aug 1, 2008

Actual Study Completion Date :

Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: evaluating the effect of -Exjade evaluating the effect of -Exjade (Deferasirox)_on oxidative stress parameters of blood cells in patients with Low risk Mylodysplastic syndrome ( MDS) with Iron over load	Drug: Exjade

Arm

Intervention/Treatment

Experimental: evaluating the effect of -Exjade

evaluating the effect of -Exjade (Deferasirox)_on oxidative stress parameters of blood cells in patients with Low risk Mylodysplastic syndrome ( MDS) with Iron over load

Drug: Exjade

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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