Spots Global Cancer Trial Database for Oral Azacitidine Combined With Venetoclax in Previously Untreated Higher-risk Myelodysplastic Syndromes
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Trial Identification
Brief Title: Oral Azacitidine Combined With Venetoclax in Previously Untreated Higher-risk Myelodysplastic Syndromes
Official Title: A Phase I/II, Open-label, Single Arm, Multicenter Dose-finding Study Assess the Safety and Preliminary Efficacy of Oral Azacitidine CC-486 (ONUREG) in Combination With Venetoclax (VENCLYXTO) in Previously Untreated Higher-risk Myelodysplastic Syndromes Ineligible for Allogenic Transplantation
Study ID: NCT05782127
Conditions
Interventions
Study Description
Brief Summary: This phase I/II open-label, dose-finding, multi-center study will assess safety and primary efficacy of Onureg and Venetoclax combination, to define the optimal biological dose and optimal treatment duration of Onureg to be used along with Venetoclax for further studies in previously untreated patients with higher-risk myelodysplastic syndromes (HR-MDS) not eligible to transplant.
Detailed Description: During phase I, three dose features of Onureg will be tested in combination with a fixed dose of Venetoclax to define the optimal biological dose for phase II. The phase II will assess safety and primary efficacy of Onureg and Venetoclax combination, to define the optimal biological dose and optimal treatment duration of Onureg to be used along with Venetoclax for further studies in previously untreated patients with HR-MDS not eligible to transplant.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CHU d'Amiens Picardie - Site sud, Amiens, , France
CHU d'Angers, Angers, , France
Hôpital Avicenne, Bobigny, , France
CHU de Grenoble, Grenoble, , France
CH Le Mans, Le Mans, , France
Hôpital Saint Vincent de Paul, Lille, , France
CHU de Limoges - Hôpital Dupuytren, Limoges, , France
CH Lyon sud, Lyon, , France
Institut Paoli Calmettes, Marseille, , France
CHI Mont-de-Marsan, Mont-de-Marsan, , France
CHU Saint Eloi, Montpellier, , France
CHU Hôtel Dieu, Nantes, , France
Hôpital Archet 1, Nice, , France
Hôpital Saint Louis, Paris, , France
Hôpital Cochin, Paris, , France
CHU de Haut-Lévèque, Pessac, , France
CHU de Poitiers, Poitiers, , France
Centre Henri Becquerel, Rouen, , France
IUCT Oncopole, Toulouse, , France
CHU de Tours - Hôpital Bretonneau, Tours, , France
CH Valence, Valence, , France
Hôpital Brabois, Vandœuvre-lès-Nancy, , France
CH Annecy Genevois, Épagny, , France
Contact Details
Name: Colombe SAILLARD, MD
Affiliation: Institut Paoli-Calmettes
Role: PRINCIPAL_INVESTIGATOR
Name: Norbert VEY, MD/PhD
Affiliation: Institut Paoli-Calmettes
Role: PRINCIPAL_INVESTIGATOR
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