search
Back to results

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

Primary Purpose

Myelodysplastic Syndrome

Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Exjade
Sponsored by
Wolfson Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndrome focused on measuring IRON, oxidative stress, MDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wolfsom Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

evaluating the effect of -Exjade

Arm Description

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

Outcomes

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.

Full Information

First Posted
March 26, 2007
Last Updated
June 13, 2014
Sponsor
Wolfson Medical Center
Collaborators
Hadassah Medical Organization, Tel-Aviv Sourasky Medical Center, Sheba Medical Center, Soroka University Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00452660
Brief Title
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

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wolfson Medical Center
Collaborators
Hadassah Medical Organization, Tel-Aviv Sourasky Medical Center, Sheba Medical Center, Soroka University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome
Keywords
IRON, oxidative stress, MDS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
evaluating the effect of -Exjade
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Exjade
Primary Outcome Measure Information:
Title
To evaluate the antioxidative effect of Exjade therapy in MDS patients
Time Frame
one year
Title
with iron over load by evaluating oxidative stress parameters
Time Frame
one year
Title
pre and post treatment
Time Frame
one year
Secondary Outcome Measure Information:
Title
To evaluate the safety and tolerability of Exjade over the treatment period.
Time Frame
one year
Title
To analyze iron overload after Exjade treatment period.
Time Frame
one year
Title
To evaluate transfusion requirements.
Time Frame
one year
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachmilewitz Eliezer, MD
Organizational Affiliation
Wolfson Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Wolfsom Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
20421274
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs