Ignite Creation Date:
2024-05-06 @ 6:47 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05782127
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2023-02-23
Brief Title:
Oral Azacitidine Combined with Venetoclax in Previously Untreated Higher-risk Myelodysplastic Syndromes
Sponsor:
Groupe Francophone des Myelodysplasies
Organization:
Groupe Francophone des Myelodysplasies
Study Overview
Official Title:
A Phase III 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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-000634-41 | EUDRACT_NUMBER | None | None |