Clinical trial NCT00452660: Evaluation the Effect of Exjade on Oxidative Stress in Low Risk Myelodysplastic Syndrome Patients With Iron Over Load
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myelodysplastic Syndrome
Keywords: IRON
oxidative stress
MDS
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Hadassah Medical Organization
name: Tel-Aviv Sourasky Medical Center
name: Sheba Medical Center
name: Soroka University Medical Center
First posted: 2007-03-27
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: To evaluate the antioxidative effect of Exjade therapy in MDS patients
timeFrame: one year
measure: with iron over load by evaluating oxidative stress parameters
timeFrame: one year
measure: pre and post treatment
timeFrame: one year
Secondary outcomes:
measure: To evaluate the safety and tolerability of Exjade over the treatment period.
timeFrame: one year
measure: To analyze iron overload after Exjade treatment period.
timeFrame: one year
measure: To evaluate transfusion requirements.
timeFrame: one year
measure: 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.
timeFrame: one year
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Wolfsom Medical Center
Study officials:
affiliation: Wolfson Medical Center
name: Rachmilewitz Eliezer, MD
role: STUDY_CHAIR
References:
citation: Ghoti H, Fibach E, Merkel D, Perez-Avraham G, Grisariu S, Rachmilewitz EA. Changes in parameters of oxidative stress and free iron biomarkers during treatment with deferasirox in iron-overloaded patients with myelodysplastic syndromes. Haematologica. 2010 Aug;95(8):1433-4. doi: 10.3324/haematol.2010.024992. Epub 2010 Apr 26. No abstract available.