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

yair levy

Status: Unknown

Conditions: Myelodysplatic Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT01548495

MDS-2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• None

Trial design

100 participants in 4 patient groups

Responded to rHuEPO treatment

Description:

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

Description:

No rise in hemoglobine consentration at normal and high dose rHuEPO treatment

Responded to high level rHuEPO

Description:

Responded to more than 80,000UI of rHuEPO treatment

No rHuEPO treatment