Anemia in Myelodysplastic SyndromesPhase 2NCT00437450
Treatment of the Anemia of Myelodysplastic Syndromes by the Association of Epoetin Beta and All Trans Retinoic Acid
A Phase 2 study testing Epoetin/Atra in people with Anemia in Myelodysplastic Syndromes, run by Groupe Francophone des Myelodysplasies at 24 sites in France.
Trial summary
The purpose of this study is To evaluate the efficacy of association of Erythropoetin (Neorecormon) and ATRA in patients with low risk myelodysplastic syndromes To evaluate the tolerance of this treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia in Myelodysplastic Syndromes
- What is being tested?
- Epoetin/Atra
- How many people
- 99 participants
- Where
- 24 sitesFrance
- Study dates
- Oct 2004to Sep 2005
- 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
- Patients ≥18 years with RA, RARS, RAEB (blasts <10%)
- Hb< 10g/dl > of 2 months or transfused since less 2 months
- Hb<12g/dl > of 2 months and thrombocytopenia defined by platelets < 50 000/mm3, or neutropenia<10 000mm3
- For women of child bearing age, necessity of contraception during all the duration of the study
Who cannot join
- Patient with lung disease, cardiac, neurological, gastro-intestinal or genito - urinary disorders not connected to genito -urinary not connected to myelodysplasia
- Patient having received intensive chemotherapy in the 3 months before inclusion in the protocol
- RAEBt
- RAEB >10% blasts
- Treatment with rHu-Epo, darbepoetin ou rHu-GCSF , 2 months before inclusion
- Patient presenting an iron , B12 vitamin or folic acid uncorrected deficit
Show all 11Show fewer
- CMML
- Uncontrolled systemic hypertension
- creatinine clearance < 300 µM/L
- Pregnant patient or in period of lactation
- Life expectancy < 6 months
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
France24 sites
CHU d'Amiens
Amiens, 84054
CHU d'Angers
Angers, 43033
CHU d'Avignon
Avignon, 84000
CH de la cote Basque
Bayonne, 64100
Hopital Avicenne
Bobigny, 93009
CHU de Caen
Caen, 14033
Hopital Percy
Clamart, 92140
CHU Dijon
Dijon, 21000
CHU Albert Michallon
Grenoble, 38043
CHRU Limoges
Limoges, 87046
CHU Edouard Herriot
Lyon, 69437
Institut Paoli Calmette
Marseille, 13009
CHU Archet
Nice, 06202
Hopital Necker
Paris, 75010
Hopital Saint Antoine
Paris, 75012
HOPITAL Cochin
Paris, 75014
Hopital Hotel Dieu
Paris, 75181
CH de Cournouaille
Quimper, 29107
CHU Robert Debre
Reims, 51092
Hopital Henri Becquerel
Rouen, 76038
Hopital Hautepierre
Strasbourg, 67098
Chu Purpan
Toulouse, 31059
CHU Bretoneau
Tours, 37044
CHU Brabois
Vandœuvre-lès-Nancy, 54511
About this study
The purpose of this study is
- To evaluate the efficacy of association of Erythropoetin (Neorecormon) and ATRA in patients with low risk myelodysplastic syndromes
- To evaluate the tolerance of this treatment
- Conditions
- Anemia in Myelodysplastic Syndromes
- Being tested
- Epoetin/Atra
- Keywords
- Anemia, myelodysplastic syndromes, Low risk, Bone Marrow diseases
- Medical subject headings
- Anemia, Myelodysplastic Syndromes, Bone Marrow Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin/AtraDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of association of Erythropoetin and ATRA in patients with low risk myelodysplastic syndromes
Secondary outcomes (1)
To evaluate the tolerance of this treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study startOct 2004
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia in 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants
Sponsor and investigators
- Lead sponsor
- Groupe Francophone des Myelodysplasies
- Sponsor type
- University, hospital or other
- Investigators
- Lionel ADES, MD, Principal investigator, Groupe Francophone des Myelodysplasies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437450
- Sponsor's protocol ID
- 040759
- Status last verified
- Feb 2007
- First submitted
- 19 Feb 2007
- Last updated
- 18 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of the Anemia of Myelodysplastic Syndromes by the Association of Epoetin Beta and All Trans Retinoic Acid
- ClinicalTrials.gov ID
- NCT00437450
- Acronym / sponsor ID
- 040759
- Conditions
- Anemia in Myelodysplastic Syndromes
- Keywords
- Anemia, myelodysplastic syndromes, Low risk, Bone Marrow diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants
- Lead sponsor
- Groupe Francophone des MyelodysplasiesUniversity, hospital or other
- Study start
- Oct 2004
- Study completion
- Sep 2005
- First posted
- 21 Feb 2007 (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.
The purpose of this study is
- To evaluate the efficacy of association of Erythropoetin (Neorecormon) and ATRA in patients with low risk myelodysplastic syndromes
- To evaluate the tolerance of this treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients ≥18 years with RA, RARS, RAEB (blasts <10%)
- Hb< 10g/dl > of 2 months or transfused since less 2 months
- Hb<12g/dl > of 2 months and thrombocytopenia defined by platelets < 50 000/mm3, or neutropenia<10 000mm3
- For women of child bearing age, necessity of contraception during all the duration of the study
Key exclusion criteria (11 listed)
- Patient with lung disease, cardiac, neurological, gastro-intestinal or genito - urinary disorders not connected to genito -urinary not connected to myelodysplasia
- Patient having received intensive chemotherapy in the 3 months before inclusion in the protocol
- RAEBt
- RAEB >10% blasts
- Treatment with rHu-Epo, darbepoetin ou rHu-GCSF , 2 months before inclusion
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/Atra | Drug | – |
Primary outcome
To evaluate the efficacy of association of Erythropoetin and ATRA in patients with low risk myelodysplastic syndromes
1 secondary outcome
To evaluate the tolerance of this treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2009.
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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.
Lionel ADES, MD principal investigator
Groupe Francophone des Myelodysplasies
24 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/Atra in people with Anemia in Myelodysplastic Syndromes, run by Groupe Francophone des Myelodysplasies at 24 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 11 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: status not confirmed, as of the sponsor's last update on 18 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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?
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?
To evaluate the efficacy of association of Erythropoetin and ATRA in patients with low risk myelodysplastic syndromes. 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 18 Nov 2009.