Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06384261
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-18
Brief Title:
A Study Comparing Venetoclax and Azacitidine Plus Cusatuzumab to Venetoclax and Azacitidine in Newly Diagnosed AML Ineligible for Intensive Therapy
Sponsor:
OncoVerity Inc
Organization:
OncoVerity Inc
Study Overview
Official Title:
Multicenter Open-label Randomized Phase 2 Study of Venetoclax and Azacitidine Plus Cusatuzumab Versus Venetoclax and Azacitidine Alone in Newly Diagnosed AML Patients Who Are Not Candidates for Intensive Therapy
Status:
RECRUITING
Status Verified Date:
2024-08
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:
The goal of this clinical trial is to learn if participants treated with the experimental drug cusatuzumab added to venetoclax and azacitidine works to treat acute myeloid leukemia AML compared to venetoclax and azacitidine Venetoclax and azacitidine are drugs commonly used to treat AML in patients that are unable to receive chemotherapy to treat AML The main question the clinical trial aims to answer is does cusatuzumab added to venetoclax and azacitidine prolong the length of time participants live compared to venetoclax and azacitidine
Detailed Description:
This is a randomized open-label multicenter Phase 2 trial to evaluate the efficacy safety and pharmacodynamics of cusatuzumab in combination with venetoclax and azacitidine compared to venetoclax and azacitidine in persons with newly diagnosed AML who are deemed ineligible for intensive chemotherapy
Potential participants will be considered ineligible for intensive chemotherapy and therefore eligible for the study if they meet the trial eligibility criteria Potential participants will undergo a diagnostic bone marrow biopsy and aspirate collected for pathology review cytogenetics fluorescence in situ hybridization FISH and polymerase chain reaction PCR analysis and other studies for confirmation of a diagnosis of AML and to define whether participants have adverse intermediate or favorable AML risk features
The enrolled trial population will be enriched for participants with adverse risk features by enrolling adverse intermediate and favorable risk participants at a ratio of 311 respectively ie 72 adverse risk 24 intermediate risk and 24 favorable risk participants will be enrolled Enrolled participants will then be randomized 21 to either the experimental arm or the active comparator arm
Potential participants will be considered ineligible for intensive chemotherapy and therefore eligible for the study if they meet the trial eligibility criteria Potential participants will undergo a diagnostic bone marrow biopsy and aspirate collected for pathology review cytogenetics fluorescence in situ hybridization FISH and polymerase chain reaction PCR analysis and other studies for confirmation of a diagnosis of AML and to define whether participants have adverse intermediate or favorable AML risk features
The enrolled trial population will be enriched for participants with adverse risk features by enrolling adverse intermediate and favorable risk participants at a ratio of 311 respectively ie 72 adverse risk 24 intermediate risk and 24 favorable risk participants will be enrolled Enrolled participants will then be randomized 21 to either the experimental arm or the active comparator arm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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