Spots Global Cancer Trial Database for Azacitidine With or Without Ceplene/Interleukin-2 in Patients With Higher Risk Myelodysplastic Syndromes
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Trial Identification
Brief Title: Azacitidine With or Without Ceplene/Interleukin-2 in Patients With Higher Risk Myelodysplastic Syndromes
Official Title: A Phase I and Phase II Study of the Efficacy and Safety of Maintenance Treatment With Azacitidine With or Without Ceplene/Interleukin-2 in Patients With Higher Risk Myelodysplastic Syndromes Who Achieved Hematological Response to Azacitidine
Study ID: NCT01324960
Conditions
Study Description
Brief Summary: A phase I study of azacitidine with Ceplene/interleukin-2 will first evaluate the safety and tolerability of this regimen in patients with higher risk myelodysplastic syndromes (MDS) who achieved a hematological response after 6 cycles of azacitidine. After approval by an independent Data Safety Monitoring Board (DSMB), the phase I study will be followed by an open label randomized phase II study designed to characterize the efficacy, safety, and tolerability of the addition of Ceplene/interleukin-2 to azacytidine in patients with higher risk myelodysplastic syndrome (MDS) who achieved a hematological response after 6 cycles of azacitidine.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CHU de Bicêtre, Le Kremlin-Bicêtre, Ile de France, France
CHU Cochin, Paris, Ile de France, France
CHU d'Amiens, Amiens, , France
CHU Angers, Angers, , France
CH d'Avignon, Avignon, , France
Hôpital de la Côte Basque, Bayonne, , France
Hopital Avicenne, Bobigny, , France
CHU de Caen, Caen, , France
CHU de, Clermont Ferrand, , France
Centre Hospitalier Sud-Francilien, Corbeil-Essonnes, , France
CHU Grenoble, Grenoble, , France
Hôpital Versailles, Le Chesnay, , France
Hôpital Saint Vincent, Lille, , France
CHRU Hurriez, Lille, , France
CHRU Limoges, Limoges, , France
Hôpital Edouard Heriot, dpt Hématologie Clinique, Lyon, , France
Hôpital Paoli-Calmettes, Marseille, , France
Hematology Dpt, Hopital de l'Hotel Dieu, Nantes, , France
CHU Archet, Nice, , France
Hopital Saint Louis, Paris, , France
Hôpital Saint Antoine, Paris, , France
Centre Hospitalier Joffre, Perpignan, , France
Hôpital Jean-Bernard, Poitiers, , France
CHRU de Reims, Reims, , France
Centre Henri Bequerel, Rouen, , France
Centre Hospitalier Universitaire de STRASBOURG, Strasbourg, , France
Hopital Purpan Service d'Hématologie Clinique, Toulouse, , France
Hopital Bretonneau, Tours, , France
Contact Details
Name: Céline BERTHON, MD
Affiliation: Groupe Francophone des Myelodisplasies
Role: PRINCIPAL_INVESTIGATOR
Name: Bruno QUESNEL, MD, PhD
Affiliation: Groupe Francophone des Myelodisplasies
Role: PRINCIPAL_INVESTIGATOR
Name: Pierre Fenaux, MD
Affiliation: Groupe francophone des Myelodisplasies
Role: PRINCIPAL_INVESTIGATOR
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