Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06357182
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-02-29
Brief Title:
Iadademstat in Combination With Azacitidine and Venetoclax in Treating Newly Diagnosed Acute Myeloid Leukemia
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
A Phase Ib Investigation of the LSD1 Inhibitor Iadademstat ORY-1001 in Combination With Azacitidine and Venetoclax in Newly Diagnosed AML
Status:
RECRUITING
Status Verified Date:
2024-07
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 I trial tests the safety side effects and best dose of iadademstat when given together with azacitidine and venetoclax in treating patients with newly diagnosed acute myeloid leukemia AML Iadademstat inhibits the LSD1 protein and may lead to inhibition of cell growth in LSD1-overexpressing cancer cells Chemotherapy drugs such as azacitidine work in different ways to stop the growth of cancer cells either by killing the cells by stopping them from dividing or by stopping them from spreading Venetoclax is in a class of medications called B-cell lymphoma-2 Bcl-2 inhibitors It may stop the growth of cancer cells by blocking Bcl-2 a protein needed for cancer cell survival Giving iadademstat with azacitidine and venetoclax may be safe tolerable andor effective in treating patients with newly diagnosed AML who cannot undergo intensive chemotherapy
Detailed Description:
PRIMARY OBJECTIVE
I Determine the maximum tolerated dose MTD andor recommended phase 2 dose RP2D of iadademstat IADA when administered as part of the investigational combination ie iadademstat azacitidine venetoclax IADAAZAVEN
SECONDARY OBJECTIVES
I Assess the preliminary efficacy of the investigational regimen based on disease remission
II Assess the preliminary efficacy of the investigational regimen based on clinical response
III Assess the safety of the investigational regimen
EXPLORATORY OBJECTIVES
I Assess survival in the absence of treatment failure hematologic relapse or progressive disease
II Assess overall survival
III Assess duration of response based on morphological assessments
IV Identify mechanisms of transcriptional reprogramming and cell death
V Identify predictive biomarkers of response to LSD1 inhibition
VI Assess participant quality of life using Patient-Reported Outcomes Common Terminology Criteria for Adverse Events PRO-CTCAE
OUTLINE This is a dose-escalation study of iadademstat in combination with azacitidine and venetoclax
Patients receive iadademstat orally PO once daily QD on days 1-5 of cycle 0 and then days 1-5 8-12 and 15-19 Patients also receive venetoclax PO QD days 1-21 or 1-28 and azacitidine subcutaneously SC QD days 1-7 Patients with complete remission CR CR with partial hematologic recovery CRh CR with incomplete blood count recovery CRi or morphologic leukemia-free state MLFS after cycle 1 continue to receive IADA PO QD on days 1-5 8-12 and 15-19 azacitidine SC QD days 1-7 and venetoclax PO QD days 1-21 or 1-28 of subsequent cycles Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients undergo echocardiography ECHO or multigated acquisition scan MUGA during screening as clinically indicated on study Patients under bone marrow biopsy throughout the trial Additionally patients undergo blood sample collection during screening and on the trial
After completion of study treatment patients are followed up every 3 months for 2 years
I Determine the maximum tolerated dose MTD andor recommended phase 2 dose RP2D of iadademstat IADA when administered as part of the investigational combination ie iadademstat azacitidine venetoclax IADAAZAVEN
SECONDARY OBJECTIVES
I Assess the preliminary efficacy of the investigational regimen based on disease remission
II Assess the preliminary efficacy of the investigational regimen based on clinical response
III Assess the safety of the investigational regimen
EXPLORATORY OBJECTIVES
I Assess survival in the absence of treatment failure hematologic relapse or progressive disease
II Assess overall survival
III Assess duration of response based on morphological assessments
IV Identify mechanisms of transcriptional reprogramming and cell death
V Identify predictive biomarkers of response to LSD1 inhibition
VI Assess participant quality of life using Patient-Reported Outcomes Common Terminology Criteria for Adverse Events PRO-CTCAE
OUTLINE This is a dose-escalation study of iadademstat in combination with azacitidine and venetoclax
Patients receive iadademstat orally PO once daily QD on days 1-5 of cycle 0 and then days 1-5 8-12 and 15-19 Patients also receive venetoclax PO QD days 1-21 or 1-28 and azacitidine subcutaneously SC QD days 1-7 Patients with complete remission CR CR with partial hematologic recovery CRh CR with incomplete blood count recovery CRi or morphologic leukemia-free state MLFS after cycle 1 continue to receive IADA PO QD on days 1-5 8-12 and 15-19 azacitidine SC QD days 1-7 and venetoclax PO QD days 1-21 or 1-28 of subsequent cycles Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients undergo echocardiography ECHO or multigated acquisition scan MUGA during screening as clinically indicated on study Patients under bone marrow biopsy throughout the trial Additionally patients undergo blood sample collection during screening and on the trial
After completion of study treatment patients are followed up every 3 months for 2 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| STUDY00026136 | OTHER | OHSU Knight Cancer Institute | None |
| NCI-2024-01262 | REGISTRY | None | None |