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Search for Predictive Markers of Efficacy of ESAs in Patients With Non-myeloid Malignancies or Myelodysplastic Syndrome (EPO)

This study has been terminated.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01546337
First received: March 1, 2012
Last updated: March 6, 2012
Last verified: March 2012
History of Changes
  Purpose

Anemia is common among cancer patients and the treatment of choice is now Erythropoiesis-Stimulating Agents (ESAs). However, some patients do not respond to treatment. The purpose of this study is to evaluate the predictive value of endogenous erythropoietin rate on the response to erythropoietin beta. First, by confirming the predictive value of endogenous erythropoietin observed / predicted ratio on this response. Then if it is confirmed by establishing the optimal value of this ratio.


Condition
Myelodysplastic Syndromes
Anemia
Hemopathies

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Search for Predictive Markers of Efficacy of Epoetin Beta (NEORECORMON) in the Treatment of Anemia in Patients With Non-myeloid Malignancies Receiving Chemotherapy or Myelodysplastic Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • response to erythropoietin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    • Complete response : increase of 2g/dl of erythropoietin rate or stopping of transfusion requirements.
    • Partial response : increase of 1 to 2g/dl rate of erythropoietin or 50% reduction of transfusion requirements.


Secondary Outcome Measures:
  • endogenous erythropoietin rate [ Time Frame: Within 8 days before inclusion ] [ Designated as safety issue: No ]
  • hemoglobin rate [ Time Frame: Weeks 0,4,8 and 12 ] [ Designated as safety issue: No ]
    Weeks 0 = first ESAs injection

  • Number of transfusions during the duration of the study [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: May 2008
Study Completion Date: November 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Detailed Description:

Anemia is common among cancer patients and the treatment of choice is now Erythropoiesis-Stimulating Agents (ESAs). However, some patients do not respond to treatment. Thus, only 50-60% of patients with multiple myeloma or non-Hodgkin lymphoma respond to ESAs. The purpose of this study is to evaluate the predictive value of endogenous erythropoietin rate on the response to erythropoietin beta. First, by confirming the predictive value of endogenous erythropoietin observed / predicted ratio on this response. Then if it is confirmed by establishing the optimal value of this ratio.

  Eligibility

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

Non-myeloid haemopathy or Myelodysplastic Syndromes patients with anemia, who needs ESAs treatment

Criteria

Inclusion Criteria:

  • Patients over 18
  • patients with non-myeloid haemopathy receiving chemotherapy or myelodysplastic syndrome
  • indication of ESAs therapy with Hb < 11g/dl

Exclusion Criteria:

  • uncontrolled hypertension
  • anemia due to deficiency
  • pregnant and lactating women
  • patient who received treatment with erythropoiesis-activating factors in the two months preceding inclusion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546337

Locations
France
Laval Hospital
Laval, France, 53015
Rennes University Hospital
Rennes, France, 35033
Yves Le Foll Hospital
Saint-Brieuc, France, 22027
Saint-Malo Hospital
Saint-Malo, France, 35403
Bretagne Atlantic Hospital
Vannes, France, 56017
Sponsors and Collaborators
Rennes University Hospital
Ministry of Health, France
Investigators
Principal Investigator: Escoffre-Barbe Martine, MD Rennes University Hospital
Study Chair: Laviolle Bruno, MD Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01546337     History of Changes
Other Study ID Numbers: CCTIRS908111
Study First Received: March 1, 2012
Last Updated: March 6, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Rennes University Hospital:
anemia
non-myeloid haemopathy
myelodysplastic syndrome
Erythropoiesis stimulating agents
predictive markers

Additional relevant MeSH terms:
Anemia
Myelodysplastic Syndromes
Preleukemia
Hematologic Diseases
Bone Marrow Diseases
Precancerous Conditions
 Neoplasms
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013