Azacitidine Combined to Epoetin Beta in International Prognostic Scoring System (IPSS) Low-risk and Intermediate-1 Myelodysplastic Syndrome (MDS) Patients, Resistant to Erythropoetin-stimulating Agents (ESA)
NCT ID: NCT01015352
Last Updated: 2014-03-19
Study Results
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Basic Information
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COMPLETED
PHASE2
98 participants
INTERVENTIONAL
2009-02-28
2014-03-31
Brief Summary
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Detailed Description
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The Primary Endpoint of this study is to determine the major erythroid response rate after 6 courses, assessed according to IWG 2000 criteria.
The Secondary Endpoints are to determine the percentage of major HI-E and minor HI-E after 4 and 6 courses according to IWG 2000, the HI-E IWG 2006 criteria, the duration of erythroid response, the red blood cell transfusion independence at 4 and 6 months, the overall survival and time to IPSS progression and the toxicity (NCI-CTAE).
The trial will enroll 98 patients (49 patients per arm)
Treatment in arm A:
Azacitidine 75mg/sqm SQ per day for 5 days every 28 days for 6 courses Dosing of each subsequent course will be adapted according to extrahematological toxicity and cytopenias.
In responders after 6 courses of azacitidine according to IWG 2000 criteria (both minor and major erythroid responses of HI-E) 12 identical additional maintenance courses will be delivered every 28 days, unless relapse occurs (according to IWG 2000 criteria).
Treatment in arm B:
• Azacitidine 75mg/sqm SQ per day for 5 days every 28 days for 6 courses.
(dosing of each subsequent course will be adapted according to extra hematological toxicity and cytopenias) AND
• Epoetin beta : 60000U weekly SQ injections Dosing of epoetin beta will be adapted according to current ASH-ASCO guidelines and black box warning of epoetin beta. Epoetin beta therapy may therefore be interrupted, in case of response to azacitidine, as soon as a hemoglobin level of 12g/dl is achieved on two sequential bimonthly blood count measurements.
A 40% dose reduction of epoetin beta will be required if:
* Hb level rise of 1 g/dl is observed within two weeks
* Hb level exceeds 11g/dl
In responders after 6 courses of azacitidine + epoetin beta, according to IWG 2000 criteria (both minor and major erythroid responses of HI-E) 12 identical additional maintenance courses of azacitidine will be delivered every 28 days, unless relapse occurs (according to IWG 2000 criteria) Epoetin beta will be administered as described above.
In both arms, each subsequent course will be delivered
* In absence of persistent grade \>2 non-hematological toxicity
* In absence of rehospitalisation for severe bleeding, infection or febrile neutropenia and non-hematological toxicity following the previous course
* If neutrophil counts are \> 1G/l or \> 50% of baseline neutrophil counts
* If platelets are \> 75G/l or \> 50% of baseline platelets counts
In case of persistent cytopenia, blood counts will be at least checked every 2 weeks, and the next course delayed until resolution of cytopenia, as defined above.
In case of persistence of cytopenia beyond day 56 of the preceding course, an new evaluation of the disease, using clinical examination, blood and bone marrow examinations +/- cytogenetics will be mandatory before eventually pursuing azacitidine at lower dosing levels.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Azacitidine 75mg/sqm SQ per day for 5 days every 28 days for 6 courses and 12 additional maintenance courses in responders.
Azacitidine
Azacitidine 75mg/sqm SQ per day for 5 days every 28 days
Arm B
Azacitidine: 75mg/sqm SQ per day for 5 days every 28 days for 6 courses AND
Epoetin beta : 60000U weekly SQ injections (to be adapted according to Hb as described above)
12 additional maintenance courses are planned in responders
Azacitidine
Azacitidine 75mg/sqm SQ per day for 5 days every 28 days
Epoetin beta
Epoetin beta : 60000U weekly SQ injections
NeoRecormon®
Interventions
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Azacitidine
Azacitidine 75mg/sqm SQ per day for 5 days every 28 days
Epoetin beta
Epoetin beta : 60000U weekly SQ injections
NeoRecormon®
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* RCMD, RA with or without ring sideroblasts
* RAEB 1, or CMML 1, if WBC \< 13 G /l according to the WHO classification
* with a low or int-1 IPSS score AND
* primary or secondary resistance to epoetin alpha/ beta (\> 60000 U/w) or darbepoetin (\> 250ug/w), administered for at least 12 weeks
* requirement of RBC transfusions \> 4 U in the previous 8 weeks
* Aged 18 years or more
* Adequate contraception, if relevant
* Negative pregnancy test if relevant
* Written Informed consent
* Ability to participate to a clinical trial and adhere to study procedures
* Health insurance
Exclusion Criteria
* Patients with a planned allogeneic bone marrow transplantation
* Creatininemia \>1.5 upper normal value or estimated Ccr less than 30ml/mn
* ALAT and ASAT \>2.5 upper normal value
* Bilirubin \>2N, except unconjugated hyperbilirubinemia due to MDS-related dyserythropoiesis
* Heart failure NYHA \> II
* Known allergy to mannitol
* Other tumor, unstable for the last three years, except in situ uterine carcinoma or basal skin tumor
* ECOG \> 2
* Life expectancy less than 3 months
18 Years
ALL
No
Sponsors
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Celgene Corporation
INDUSTRY
Roche Pharma AG
INDUSTRY
Groupe Francophone des Myelodysplasies
OTHER
Responsible Party
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Principal Investigators
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Simone Boehrer, MD
Role: PRINCIPAL_INVESTIGATOR
Groupe Francophone des Myélodysplasies
Claude Gardin, MD
Role: PRINCIPAL_INVESTIGATOR
Groupe Francophone des Myélodysplasies
Locations
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CHU d'Amiens
Amiens, , France
Hôpital Angers
Angers, , France
Hôpital Avignon
Avignon, , France
Hôpital de la Côte Basque
Bayonne, , France
Hopital Avicenne
Bobigny, , France
Hôpital Boulogne Sur Mer
Boulogne-sur-Mer, , France
Hopital Clémenceau
Caen, , France
Hôpital le Bocage
Dijon, , France
Hôpital Versailles
Le Chesnay, , France
Hôpital kremlin Bicêtre
Le Kremlin-Bicêtre, , France
Hôpital Saint Vincent
Lille, , France
Hôpital Huriez
Lille, , France
Hôpital Limoges
Limoges, , France
Hôpital Edouard Herriot
Lyon, , France
Hôpital Paoli-Calmettes
Marseille, , France
Hôpital Brabois
Nancy, , France
Hôpital Hôtel Dieu
Nantes, , France
Hôpital Archet1
Nice, , France
Hôpital La Source
Orléans, , France
Hôpital Lariboisière
Paris, , France
Hôpital Saint Louis
Paris, , France
Hôpital Saint Antoine
Paris, , France
Hôpital Cochin
Paris, , France
Hôpital Maréchal Joffre
Perpignan, , France
Hôpital Jean-Bernard
Poitiers, , France
Hôpital Reims
Reims, , France
Hôpital Henri Becquerel
Rouen, , France
Hôpital Hautepierre
Strasbourg, , France
Hôpital Purpan
Toulouse, , France
Countries
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References
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Thepot S, Ben Abdelali R, Chevret S, Renneville A, Beyne-Rauzy O, Prebet T, Park S, Stamatoullas A, Guerci-Bresler A, Cheze S, Tertian G, Choufi B, Legros L, Bastie JN, Delaunay J, Chaury MP, Sanhes L, Wattel E, Dreyfus F, Vey N, Chermat F, Preudhomme C, Fenaux P, Gardin C; Groupe Francophone des Myelodysplasies (GFM). A randomized phase II trial of azacitidine +/- epoetin-beta in lower-risk myelodysplastic syndromes resistant to erythropoietic stimulating agents. Haematologica. 2016 Aug;101(8):918-25. doi: 10.3324/haematol.2015.140988. Epub 2016 May 26.
Related Links
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(Website of the french group of MDS)
Other Identifiers
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GFM-Aza-Epo-2008-01
Identifier Type: -
Identifier Source: org_study_id
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