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

NCT00452660 | Completed Phase 4 DMC

• 1 other identifier: CICL670A2412-HMO-CTIL
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Myelodysplastic Syndrome

Keywords

IRON; oxidative stress; MDS

Outcome Measures

Primary Outcomes (3)

• To evaluate the antioxidative effect of Exjade therapy in MDS patients

  one year

• with iron over load by evaluating oxidative stress parameters

  one year

• pre and post treatment

  one year

Secondary Outcomes (4)

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

  one year

• To analyze iron overload after Exjade treatment period.

  one year

• To evaluate transfusion requirements.

  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.

  one year

Study Arms (1)

evaluating the effect of -Exjade

EXPERIMENTAL

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

Interventions

Exjade DRUG

evaluating the effect of -Exjade

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wolfson Medical Center: lead
• Hadassah Medical Organization: collaborator
• Tel-Aviv Sourasky Medical Center: collaborator
• Sheba Medical Center: collaborator
• Soroka University Medical Center: collaborator

Study Sites (1)

Wolfsom Medical Center

Holon, 58100, Israel

Location

Related Publications (1)

• 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.

  PMID: 20421274 DERIVED

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Deferasirox

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Rachmilewitz Eliezer, MD

  Wolfson Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Hematology Department , E. Wolfson Medical center ,Holon- Israel.

Study Record Dates

• First Submitted: March 26, 2007
• First Posted: March 27, 2007
• Study Start: May 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: June 16, 2014

Record last verified: 2014-06

Locations

IL (1)