Autoantibodies Against Human Recombinant Erythropoietin in Myelodysplatic Syndrome Patients (MDS)

March 8, 2012 updated by: yair levy

Investigating Recombinant Human Erythropoietin (rHuEPO) Treatment Efficacy Depending on the Presence of Erythropoietin Autoantibodies in Myelodysplatic Syndrome (MDS) Patients

The purpose of this study is to verify the presents of autoantibodies in serums of MDS serum patients who had an inadequate response or did not respond to Recombinant human erythropoietin (rHuEPO) treatment.

Study Overview

Status

Unknown

Conditions

Detailed Description

MDS are a heterogeneous group of hematologic disorders broadly characterized by cytopenias associated with a dimorphic and usually cellular bone marrow, and by consequent ineffective blood cell production. 85% of patients have a severe anemia which is Associated with lowering quality of life and Often requires blood transfusions. Historically, only stem cell transplantation offers cure. however, multiple new drugs have been approved for treatment, such as to Recombinant human erythropoietin (rHuEPO) treatment for dealing with the anemia. rHuEPO treatment can improve hematocrit level in 25% of patient which leaves the rest with the need of other treatment solution. Studies have shown presents of anti- rHuEPO in blood serums which followed Treatment of other diseases. These findings can indicate the possibility of the presence of antibodies in MDS patients as well.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar- Saba, Israel, 44531
        • Meir Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

MDS patient from meir health care center

Description

Inclusion Criteria:

  • Followed up hematological patients
  • Pateint recieving rHuEPO treatment (except control group)
  • Pateint signed informed consent

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Responded to rHuEPO treatment
response to EPO was defined as a rise in untransfused hemoglobin concentration of at least 2 g/dl or a 50% decrease in transfusion requirements over the treatment period
IR to rHuEPO treatment
No rise in hemoglobine consentration at normal and high dose rHuEPO treatment
Responded to high level rHuEPO
Responded to more than 80,000UI of rHuEPO treatment
No rHuEPO treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlate the Presence of Erythropoietin autoantibodies titer in MDS patients with an inadequate response (IR) to Human Recombinant Erythropoietin treatment
Time Frame: 1 year

Response to Erythropoietine (EPO) was defined as a rise in untransfused hemoglobin concentration of at least 2 g/dl or a 50% decrease in transfusion requirements over the treatment period.

Detection of Erythropoietin autoantibodies was performed by "Home-made ELISA" test.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

yair levy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Anticipated)

May 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

February 28, 2012

First Submitted That Met QC Criteria

March 7, 2012

First Posted (Estimate)

March 8, 2012

Study Record Updates

Last Update Posted (Estimate)

March 9, 2012

Last Update Submitted That Met QC Criteria

March 8, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDS-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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