Myelodysplastic SyndromesEPONCT01546337
Search for Predictive Markers of Efficacy of ESAs in Patients With Non-myeloid Malignancies or Myelodysplastic Syndrome
An observational study of Myelodysplastic Syndromes and Anemia, run by Rennes University Hospital at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes, Anemia, Hemopathies
- How many people
- 30 participants
- Where
- 5 sitesFrance
- Study dates
- May 2008to Nov 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non-myeloid haemopathy or Myelodysplastic Syndromes patients with anemia, who needs ESAs treatment
Who may be able to join
- Patients over 18
- patients with non-myeloid haemopathy receiving chemotherapy or myelodysplastic syndrome
- indication of ESAs therapy with Hb < 11g/dl
Who cannot join
- uncontrolled hypertension
- anemia due to deficiency
- pregnant and lactating women
- patient who received treatment with erythropoiesis-activating factors in the two months preceding inclusion
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Laval Hospital
Laval, 53015
Rennes University Hospital
Rennes, 35033
Yves Le Foll Hospital
Saint-Brieuc, 22027
Saint-Malo Hospital
St-Malo, 35403
Bretagne Atlantic Hospital
Vannes, 56017
About this study
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
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.
- Conditions
- Myelodysplastic Syndromes, Anemia, Hemopathies
- Keywords
- anemia, non-myeloid haemopathy, myelodysplastic syndrome, Erythropoiesis stimulating agents, predictive markers
- Medical subject headings
- Myelodysplastic Syndromes, Anemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (3)
endogenous erythropoietin rate
Measured: Within 8 days before inclusion
hemoglobin rate
Weeks 0 = first ESAs injection
Measured: Weeks 0,4,8 and 12
Number of transfusions during the duration of the study
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startMay 2008
- Primary completionMay 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Escoffre-Barbe Martine, MD, Principal investigator, Rennes University HospitalLaviolle Bruno, MD, Study chair, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546337
- Sponsor's protocol ID
- CCTIRS908111
- Acronym
- EPO
- Status last verified
- Mar 2012
- First submitted
- 1 Mar 2012
- Last updated
- 7 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01546337
- Acronym / sponsor ID
- EPO / CCTIRS908111
- Conditions
- Myelodysplastic Syndromes, Anemia, Hemopathies
- Keywords
- anemia, non-myeloid haemopathy, myelodysplastic syndrome, Erythropoiesis stimulating agents, predictive markers
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- May 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-myeloid haemopathy or Myelodysplastic Syndromes patients with anemia, who needs ESAs treatment
Key inclusion criteria (3 listed)
- Patients over 18
- patients with non-myeloid haemopathy receiving chemotherapy or myelodysplastic syndrome
- indication of ESAs therapy with Hb < 11g/dl
Key exclusion criteria (4 listed)
- uncontrolled hypertension
- anemia due to deficiency
- pregnant and lactating women
- patient who received treatment with erythropoiesis-activating factors in the two months preceding inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
response to erythropoietin
Time frame: 12 weeks
* 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.
3 secondary outcomes
endogenous erythropoietin rate
Time frame: Within 8 days before inclusion
hemoglobin rate
Time frame: Weeks 0,4,8 and 12
Number of transfusions during the duration of the study
Time frame: 12 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Escoffre-Barbe Martine, MD principal investigator
Rennes University Hospital
Laviolle Bruno, MD study chair
Rennes University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndromes and Anemia, run by Rennes University Hospital at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response to erythropoietin (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2012.