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TerminatedNCT01546337EPOUpdated Mar 7, 2012

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

An observational study in Myelodysplastic Syndromes, Anemia and Hemopathies, sponsored by Rennes University Hospital. Terminated at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-07.

Sponsored by Rennes University Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Myelodysplastic Syndromes
  • Anemia
  • Hemopathies

Keywords

  • anemia
  • non-myeloid haemopathy
  • myelodysplastic syndrome
  • Erythropoiesis stimulating agents
  • predictive markers
03

In context

Preleukemia

1,317 studies on the registry are indexed under Preleukemia; 57 are open to participants now.

This study's enrollment of 30 is below the median of 114 across 116 observational studies indexed under Preleukemia.

Browse Preleukemia studies →

Lead sponsor

Rennes University Hospital is the lead sponsor of 440 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (actual)
06

What researchers measure

Primary outcomes

  1. response to erythropoietin

    * 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.

    Time frame: 12 weeks

Secondary outcomes

  1. endogenous erythropoietin rate

    Time frame: Within 8 days before inclusion

  2. hemoglobin rate

    Weeks 0 = first ESAs injection

    Time frame: Weeks 0,4,8 and 12

  3. Number of transfusions during the duration of the study

    Time frame: 12 weeks

07

Study locations

5 sites
  • Laval Hospital
    Laval, 53015, France
  • Rennes University Hospital
    Rennes, 35033, France
  • Yves Le Foll Hospital
    Saint-Brieuc, 22027, France
  • Saint-Malo Hospital
    Saint-Malo, 35403, France
  • Bretagne Atlantic Hospital
    Vannes, 56017, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01546337
Lead sponsor
Rennes University Hospital
Collaborators
Ministry of Health, France
Responsible party
Sponsor
First posted
Mar 7, 2012
Start date
May 2008
Primary completion
May 2009
Completion
Nov 2009
Last update
Mar 7, 2012

Study contacts

Escoffre-Barbe Martine, MD
principal investigator · Rennes University Hospital
Laviolle Bruno, MD
study chair · Rennes University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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