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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Myelodysplastic Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Exjade

Intervention Type DRUG

Interventions

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Exjade

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No