Autoantibodies Against Human Recombinant Erythropoietin in Myelodysplatic Syndrome Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Myelodysplatic Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Followed up hematological patients Pateint recieving rHuEPO treatment (except control group) Pateint signed informed consent Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Responded to rHuEPO treatment<br>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<br>No rise in hemoglobine consentration at normal and high dose rHuEPO treatment | |
| Responded to high level rHuEPO<br>Responded to more than 80,000UI of rHuEPO treatment | |
| No rHuEPO treatment<br> | |

What is the study measuring?
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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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MDS, Autoantibodies, Erythropoietin, Autoantibodies in MDS patients treated with EPO