Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
99 participants
INTERVENTIONAL
2006-12-31
2008-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Study drug: Darbepoetin alfa (Aranesp) 500 microg every two weeks subcutaneously during 12 weeks, combined to filgrastim 300 microg twice weekly for an additional 12 weeks in non responders.
Response will be evaluated at 12 weeks. Patients with major or minor erythroid response (HI-E major or minor according to IWG 2000 criteria) will be continued on Aranesp. In non-responders, an additional 12 weeks of Aranesp at the same dosing, combined to Filgrastim (300 ug twice weekly, then adjusted to maintain WBC between 5000 and 10000/mm3) will be proposed. In case of response, the treatment will be continued for a total duration of 24 months. If Hb level reaches levels \> 13 g/dl at any time, Aranesp should be discontinued until Hb levels are less than 12 g/dl. Aranesp should then be resumed at 500 µg/injection every 3 weeks. Intervals between injections should be further increased by one week every time they lead to Hb levels \> 13 g/dl. The purpose of this dose adjustment is to reach the Aranesp schedule allowing a maintenance Hb level between 11 and 12 g/dl.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Darbepoetin
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* RA, RAS, RAEB with marrow blasts \< 10% (according to FAB),
* RA, RARS, RCMD, RAEB 1, CMML 1 with ≤ 10% WBC counts \< 13000/mm3 (according to WHO classification)
* Anemia, defined by Hb \< 10 g/dl or RBC transfusion requirement in the absence of other causes of anemia (especially renal failure, iron, or folate deficiency)
* IPSS ≤ 1(ie IPSS low or intermediate 1)
* EPO level \< 500 UI/L
* Ability to perform physical tests of exercise tolerance
* No renal failure (creatinine ≤ 120% normal upper value for the center)
* No underlying severe condition
* ECOG performance status score of 0, 1, or 2
* Must be 18 years of age or older at the time of screening
* Written informed consent
Exclusion Criteria
* MDS with IPSS \> 1 (int 2 or high score)
* Chronic myelomonocytic leukemia with \> 10% marrow blasts or WBC \> 13000/mm3
* Uncontrolled systemic hypertension
* Cardiac condition: uncontrolled angina, congestive heart failure, or uncontrolled cardiac arrhythmia
* Creatinine level \> 120% upper normal value for the center.
* Clinically significant systemic infection or chronic inflammatory disease (eg, rheumatoid arthritis) present at the time of screening
* Serum folate ≤ 2.0 ng/mL or vitamin B12 ≤ 200 pg/mL (anemia related to nutritional deficiencies)
* Other causes of anemia (eg, hemolysis, bleeding, sickle cell anemia, renal disease)
* Pregnant (ie, positive βhCG test) or breast feeding female subjects
* Women of childbearing potential and not using adequate contraceptives
* Known positive antibody response to an erythropoietic growth factor
* Known hypersensitivity to darbepoetin alpha or any of its excipients, or to recombinant erythropoietins
* Patient unable to understand the protocol or to be adequately followed up.
* History of seizures
* Previous history of thrombotic events
* Concomitant treatment with thalidomide
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Groupe Francophone des Myelodysplasies
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Charikleia KELAIDI, MD
Role: PRINCIPAL_INVESTIGATOR
Groupe Francophone des Myelodysplasies
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU d'Amiens
Amiens, , France
CHU d'Angers
Angers, , France
CHU d'Avignon
Avignon, , France
CH de la Cote Basque
Bayonne, , France
CHU de Brest - Hopital Morvan
Brest, , France
CHU de Caen
Caen, , France
Hopital Percy
Clamart, , France
Hopital Henri Mondor
Créteil, , France
CHU de Dijon
Dijon, , France
CHU Albert Michallon
Grenoble, , France
CHRU Hurriez
Lille, , France
CHRU Limoges
Limoges, , France
Hopital Edouard Herriot
Lyon, , France
Hopital Paoli Calmette
Marseille, , France
Hopital Hotel Dieu
Nantes, , France
CHU Archet
Nice, , France
Hopital Hotel Dieu
Paris, , France
Hopital Hotel Dieu
Paris, , France
Hopital St Louis
Paris, , France
Hopital Saint Antoine
Paris, , France
Hopital Cochin
Paris, , France
Hopital Jean-Bernard
Poitiers, , France
CHU Robert Debre
Reims, , France
CHU Pontchaillou
Rennes, , France
Hopital Henri Becquerel
Rouen, , France
Hopital Hautepierre
Strasbourg, , France
Hopital Purpan
Toulouse, , France
Hopital Bretonneau
Tours, , France
CHU Nancy-Brabois
Vandœuvre-lès-Nancy, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Denis CAILLOT
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Kelaidi C, Beyne-Rauzy O, Braun T, Sapena R, Cougoul P, Ades L, Pillard F, Lamberto C, Charniot JC, Guerci A, Choufi B, Stamatoullas A, Slama B, De Renzis B, Ame S, Damaj G, Boyer F, Chaury MP, Legros L, Cheze S, Testu A, Gyan E, Bene MC, Rose C, Dreyfus F, Fenaux P. High response rate and improved exercise capacity and quality of life with a new regimen of darbepoetin alfa with or without filgrastim in lower-risk myelodysplastic syndromes: a phase II study by the GFM. Ann Hematol. 2013 May;92(5):621-31. doi: 10.1007/s00277-013-1686-4. Epub 2013 Jan 29.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GFM-DAR500-2006-01
Identifier Type: -
Identifier Source: org_study_id