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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Meir Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
yair levy, Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01548495
First received: February 28, 2012
Last updated: March 8, 2012
Last verified: March 2012
  Purpose

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.


Condition
Myelodysplatic Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating Recombinant Human Erythropoietin (rHuEPO) Treatment Efficacy Depending on the Presence of Erythropoietin Autoantibodies in Myelodysplatic Syndrome (MDS) Patients

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Correlate the Presence of Erythropoietin autoantibodies titer in MDS patients with an inadequate response (IR) to Human Recombinant Erythropoietin treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

MDS patient from meir health care center

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01548495

Locations
Israel
Meir Medical center Not yet recruiting
Kfar- Saba, Israel, 44531
Contact: Yair Levy, prop    972-09-7472952    levy.yair@clalit.org.il   
Contact: yael hava eizikovits, mrs    972-0546573015    yael.eizikovits@clalit.org.il   
Principal Investigator: yaei levy, prop         
Principal Investigator: yair levy, prop         
Sponsors and Collaborators
yair levy
  More Information

No publications provided

Responsible Party: yair levy, director of internal medicin E department, Meir Medical Center
ClinicalTrials.gov Identifier: NCT01548495     History of Changes
Other Study ID Numbers: MDS-2011
Study First Received: February 28, 2012
Last Updated: March 8, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Meir Medical Center:
MDS
Autoantibodies
Erythropoietin
Autoantibodies in MDS patients treated with EPO

Additional relevant MeSH terms:
Autoantibodies
Epoetin alfa
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014