Myelodysplastic SyndromesPhase 2EPO-QoLNCT02428686
Treatment of Anemia With Epoetin Beta in Low Risk Myelodysplastic Syndrome (MDS)
A Phase 2 study testing Epoetin beta (NeoRecormon) in people with Myelodysplastic Syndromes, run by Groupe Francophone des Myelodysplasies at 31 sites in France.
Trial summary
Chronic anemia is the symptom most frequently found at diagnosis in low risk myelodysplastic syndrome. It generates an increased rate of morbidity and mortality in this population of patients whose median age is high and the rate of co-mobidities important. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- Epoetin beta (NeoRecormon)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 31 sitesFrance
- Study dates
- Jun 2010to Mar 2014
- Phase
- Phase 2
- 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
Who may be able to join
- Written informed consent
- Must be 18 years of age or older at the time of screening
- Myelodysplastic Syndrome of the following subtypes : RA, RAS, RCMD, RCMD-RS, RAEB 1, with IPSS score low or intermediate 1 (IPSS score < 1 ) and with anemia defined by Hb < 10 g/dl (with RBC transfusion requirement or not)
- For women of childbearing potential, need for effective contraception throughout the study period.
Who cannot join
- Intensive Chemotherapy within 3 months before inclusion
- Myelodysplastic Syndrome with IPSS score >1
- Treatment with rHu-Epo or rHu-GCSF within 2 months before inclusion
- EGOG > 3 ;
- Other causes of anemia (eg. , Iron deficiency, vitamin B12 or folic acid, hypothyroidism before correction)
- Uncontrolled arterial hypertension
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- Life expectancy less than 6 months
- CMML
- Pregnant or breast feeding female subjects
- Patients with creatinine clearance less than 30ml/min.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
France31 sites
CHU d'AMIENS
Amiens, 80054
CH Angers
Angers, 49 000
CH d'Avignon-305 rue Follereau-
Avignon, 84000
Hopital de la Cote Basque
Bayonne, 64100
Hôpital Avicenne
Bobigny, 93 000
Hôpital Boulogne Sur Mer
Boulogne-sur-Mer, 62321
CHU de Brest
Brest, 29609
CHU Clémenceau
Caen, 14033
CH René Dubos
Cergy-Pontoise, 95303
CHU de Bicêtre
Le Kremlin-Bicêtre, Île-de-France Region, 94275
Centre Hospitalier du Mans
Le Mans, 72037
CHRU Huriez
Lille, 59037
Hopital Saint-Vincent de Paul-
Lille, 59160
CHRU de Limoges
Limoges, 87046
centre hospitalier de Mantes-la-jolie
Mantes-la-Jolie, 78201
Institut Paoli Calmette
Marseille, 13273
CHU Brabois
Nancy, 54511
Hematology Dpt, Hopital de l'Hotel Dieu
Nantes, 44093
Hôpital Américain de Paris
Neuilly-sur-Seine, 92200
CHU Archet
Nice, 06202
Hôpital La Source
Orléans, 45067
Hôpital Saint Louis
Paris, 75475
Hôpital Saint-Antoine.
Paris, 75571
Hopital Cochin
Paris, 75679
Hôpital Jean Bernard
Poitiers, 86021
Centre Hospitalier de la région d'Annecy
Pringy, 74374
CHU de Reims
Reims, 51092
Centre Henri Becquerel
Rouen, 76038
Centre Hospitalier Universitaire de STRASBOURG
Strasbourg, 67098
Chu Purpan
Toulouse, 31059
Hopital Bretonneau
Tours, 37044
About this study
Official title: Treatment of Anemia With Epoetin Beta in Low Risk Myelodysplastic Syndrome With Analysis of the Impact on Quality of Life and Functional Capacity of Patients
Chronic anemia is the symptom most frequently found at diagnosis in low risk myelodysplastic syndrome. It generates an increased rate of morbidity and mortality in this population of patients whose median age is high and the rate of co-mobidities important. The historical treatment is limited to transfusion support with a significant impact on quality of life and the incidence of secondary haemosiderosis, which contributes to the emergence of co-morbidities, especially cardiovascular. Treatment with rHuEPO allows for overall erythroid response in 40-60% of patients treated.
In this trial, the investigators intend to study the interest of a treatment with epoetin beta in patients with anemia <10 g / dL in the context of a myelodysplastic syndrome with IPSS score <1.
Read more
In addition to studying the erythroid response, the investigators will measure the impact on quality of life and functional performance.
Patients will receive epoetin beta (60 000UI/week). Response will be assessed after 12 and 24 weeks of treatment.
Read the detailed description
Objective of the trial Assess the level of haematological response according to IWG 2000 and IWG 2006 criteria with a pattern of administration of high doses epoetin beta (NeoRecormon ®) for 12 and 24 weeks of treatment;
To evaluate the predictive value of the rate of reticulocytes at Day 8 on the erythroid response;
- Assess time to response
- Assess tolerance
- Assess the impact on quality of life using the FACT-An and EQ-5D measurement scales;
- Assess functional capacity:
Cardiovascular performance on effort by the 6-minute walk test Performing the " Short Physical Performance Battery " tests
Evaluation The evaluation of response according to the IWG 2000 and IWG 2006 criteria will be held at 12 and 24 weeks of treatment
- Conditions
- Myelodysplastic Syndromes
- Being tested
- Epoetin beta (NeoRecormon)
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin beta (NeoRecormon)Drug
Also called NeoRecormon
Epoetin beta 60 000 IU/week
| Study group | Role | What they receive |
|---|---|---|
| epoetin beta | Experimental | Not described Receives: Drug: Epoetin beta (NeoRecormon) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the level of haematological response according to IWG 2006 criteria with a pattern of administration of high doses epoetin beta (NeoRecormon ®) for 12 and 24 weeks of treatment
Measured: 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startJun 2010
- Primary completionMar 2014
- Study completionMar 2014
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.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Francophone des Myelodysplasies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428686
- Sponsor's protocol ID
- GFM EPO QoL
- Acronym
- EPO-QoL
- Status last verified
- Apr 2015
- First submitted
- 24 Nov 2011
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Anemia With Epoetin Beta in Low Risk Myelodysplastic Syndrome With Analysis of the Impact on Quality of Life and Functional Capacity of Patients
- ClinicalTrials.gov ID
- NCT02428686
- Acronym / sponsor ID
- EPO-QoL / GFM EPO QoL
- Conditions
- Myelodysplastic Syndromes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Groupe Francophone des MyelodysplasiesUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 29 Apr 2015 (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.
Chronic anemia is the symptom most frequently found at diagnosis in low risk myelodysplastic syndrome. It generates an increased rate of morbidity and mortality in this population of patients whose median age is high and the rate of co-mobidities important. The historical treatment is limited to transfusion support with a significant impact on quality of life and the incidence of secondary haemosiderosis, which contributes to the emergence of co-morbidities, especially cardiovascular. Treatment with rHuEPO allows for overall erythroid response in 40-60% of patients treated.
In this trial, the investigators intend to study the interest of a treatment with epoetin beta in patients with anemia <10 g / dL in the context of a myelodysplastic syndrome with IPSS score <1.
In addition to studying the erythroid response, the investigators will measure the impact on quality of life and functional performance.
Patients will receive epoetin beta (60 000UI/week). Response will be assessed after 12 and 24 weeks of treatment.
Detailed description
Objective of the trial Assess the level of haematological response according to IWG 2000 and IWG 2006 criteria with a pattern of administration of high doses epoetin beta (NeoRecormon ®) for 12 and 24 weeks of treatment;
To evaluate the predictive value of the rate of reticulocytes at Day 8 on the erythroid response;
- Assess time to response
- Assess tolerance
- Assess the impact on quality of life using the FACT-An and EQ-5D measurement scales;
- Assess functional capacity:
Cardiovascular performance on effort by the 6-minute walk test Performing the " Short Physical Performance Battery " tests
Evaluation The evaluation of response according to the IWG 2000 and IWG 2006 criteria will be held at 12 and 24 weeks of treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| epoetin beta | Experimental | Drug: Epoetin beta (NeoRecormon) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent
- Must be 18 years of age or older at the time of screening
- Myelodysplastic Syndrome of the following subtypes : RA, RAS, RCMD, RCMD-RS, RAEB 1, with IPSS score low or intermediate 1 (IPSS score < 1 ) and with anemia defined by Hb < 10 g/dl (with RBC transfusion requirement or not)
- For women of childbearing potential, need for effective contraception throughout the study period.
Key exclusion criteria (10 listed)
- Intensive Chemotherapy within 3 months before inclusion
- Myelodysplastic Syndrome with IPSS score >1
- Treatment with rHu-Epo or rHu-GCSF within 2 months before inclusion
- EGOG > 3 ;
- Other causes of anemia (eg. , Iron deficiency, vitamin B12 or folic acid, hypothyroidism before correction)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epoetin beta (NeoRecormon)Also: NeoRecormonEpoetin beta 60 000 IU/week | Drug | epoetin beta |
Primary outcome
Assess the level of haematological response according to IWG 2006 criteria with a pattern of administration of high doses epoetin beta (NeoRecormon ®) for 12 and 24 weeks of treatment
Time frame: 12 and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epoetin beta (NeoRecormon) in people with Myelodysplastic Syndromes, run by Groupe Francophone des Myelodysplasies at 31 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assess the level of haematological response according to IWG 2006 criteria with a pattern of administration of high doses epoetin beta (NeoRecormon ®) for 12 and 24 weeks of treatment (time frame: 12 and 24 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 29 Apr 2015.