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NCT Number: NCT00452660

Evaluation 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.

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Key information

Conditions

Myelodysplastic Syndrome Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myelodysplastic Syndromes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wolfsom Medical Center

Holon, 58100, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exjade

Drug

Primary outcomes

  1. To evaluate the antioxidative effect of Exjade therapy in MDS patients

    Time frame: one year

  2. with iron over load by evaluating oxidative stress parameters

    Time frame: one year

  3. pre and post treatment

    Time frame: one year

Secondary outcomes

  1. To evaluate the safety and tolerability of Exjade over the treatment period.

    Time frame: one year

  2. To analyze iron overload after Exjade treatment period.

    Time frame: one year

  3. To evaluate transfusion requirements.

    Time frame: one year

  4. 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

Sponsors and collaborators

Lead sponsor

Wolfson Medical Center

Other Gov

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 27, 2007
Registry last updated
Jun 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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