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

June 13, 2014 updated by: eliezer rachmilewitz, Wolfson Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Holon, Israel, 58100
        • Wolfsom Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the antioxidative effect of Exjade therapy in MDS patients
Time Frame: one year
one year
with iron over load by evaluating oxidative stress parameters
Time Frame: one year
one year
pre and post treatment
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety and tolerability of Exjade over the treatment period.
Time Frame: one year
one year
To analyze iron overload after Exjade treatment period.
Time Frame: one year
one year
To evaluate transfusion requirements.
Time Frame: one year
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.
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wolfson Medical Center

Collaborators

Hadassah Medical Organization
Tel-Aviv Sourasky Medical Center
Sheba Medical Center
Soroka University Medical Center

Investigators

  • Study Chair: Rachmilewitz Eliezer, MD, Wolfson medical center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (ACTUAL)

August 1, 2008

Study Completion (ACTUAL)

August 1, 2008

Study Registration Dates

First Submitted

March 26, 2007

First Submitted That Met QC Criteria

March 26, 2007

First Posted (ESTIMATE)

March 27, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

June 16, 2014

Last Update Submitted That Met QC Criteria

June 13, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CICL670A2412-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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