We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00452660
First Posted: March 27, 2007
Last Update Posted: June 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Hadassah Medical Organization
Tel-Aviv Sourasky Medical Center
Sheba Medical Center
Soroka University Medical Center
Information provided by (Responsible Party):
eliezer rachmilewitz, Wolfson Medical Center
  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: 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

Resource links provided by NLM:


Further study details as provided by eliezer rachmilewitz, Wolfson Medical Center:

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

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

Enrollment: 21
Study Start Date: May 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00452660


Locations
Israel
Wolfsom Medical Center
Holon, Israel, 58100
Sponsors and Collaborators
Wolfson Medical Center
Hadassah Medical Organization
Tel-Aviv Sourasky Medical Center
Sheba Medical Center
Soroka University Medical Center
Investigators
Study Chair: Rachmilewitz Eliezer, MD Wolfson Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: eliezer rachmilewitz, Head of Hematology Department , E. Wolfson Medical center ,Holon- Israel., Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT00452660     History of Changes
Other Study ID Numbers: CICL670A2412-HMO-CTIL
First Submitted: March 26, 2007
First Posted: March 27, 2007
Last Update Posted: June 16, 2014
Last Verified: June 2014

Keywords provided by eliezer rachmilewitz, Wolfson Medical Center:
IRON
oxidative stress
MDS

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