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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Wolfson Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Hadassah Medical Organization
Sorasky MC
Sheba Medical Center
Soroka University Medical Center
Information provided by:
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT00452660
First received: March 26, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose

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 Intervention Phase
Myelodysplastic Syndrome
Drug: Exjade
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Wolfson Medical Center:

Primary Outcome Measures:
  • To evaluate the antioxidative effect of Exjade therapy in MDS patients
  • with iron over load by evaluating oxidative stress parameters
  • pre and post treatment

Secondary Outcome Measures:
  • To evaluate the safety and tolerability of Exjade over the treatment period.
  • To analyze iron overload after Exjade treatment period.
  • To evaluate transfusion requirements.
  • 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.

Estimated Enrollment: 30
Study Start Date: May 2007
Estimated Study Completion Date: August 2008
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00452660

Contacts
Contact: Rachmilewitz Eliezer, MD +972-3-5028778 rachmilewitz@wolfson.health.gov.il
Contact: Winder Asher, MD 972 54 7542024 awinder@post.tau.ac.il

Sponsors and Collaborators
Wolfson Medical Center
Hadassah Medical Organization
Sorasky MC
Sheba Medical Center
Soroka University Medical Center
Investigators
Study Chair: Rachmilewitz Eliezer, MD Wolfson Medical Center
  More Information

No publications provided by Wolfson Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00452660     History of Changes
Other Study ID Numbers: CICL670A2412-HMO-CTIL
Study First Received: March 26, 2007
Last Updated: March 26, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Wolfson Medical Center:
IRON
oxidative stress
MDS

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Iron Overload
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Iron Metabolism Disorders
Metabolic Diseases
Deferasirox
Iron Chelating Agents
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014