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

Myelodysplastic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00452660
• Other study ID #: CICL670A2412-HMO-CTIL
• Status: Completed
• Phase: Phase 4
• First received: March 26, 2007
• Last updated: June 13, 2014
• Start date: May 2007
• Est. completion date: August 2008

Study information

• Verified date: June 2014
• Source: Wolfson Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Iron Overload
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• Exjade

Locations

Country	Name	City	State
Israel	Wolfsom Medical Center	Holon

Sponsors (5)

Lead Sponsor	Collaborator
Wolfson Medical Center	Hadassah Medical Organization, Sheba Medical Center, Soroka University Medical Center, Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the antioxidative effect of Exjade therapy in MDS patients		one year	No
Primary	with iron over load by evaluating oxidative stress parameters		one year	No
Primary	pre and post treatment		one year	No
Secondary	To evaluate the safety and tolerability of Exjade over the treatment period.		one year	No
Secondary	To analyze iron overload after Exjade treatment period.		one year	No
Secondary	To evaluate transfusion requirements.		one year	No
Secondary	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.		one year	No