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Anti-metabolites
Treatment Dose Level 2 (iadademstat, azacitidine, venetoclax) for Myelodysplastic Syndrome
Phase 1
Waitlist Available
Led By Curtis A Lachowiez
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up start of iada (day 1 of the monotherapy lead in, cycle 0 day 1 to the end of cycle 1 (each cycle is 28 days)
Awards & highlights
Study Summary
This trial is testing the safety and effectiveness of a new drug called iadademstat when used in combination with azacitidine and venetoclax to treat patients with newly diagnosed acute myel
Who is the study for?
This trial is for adults with newly diagnosed acute myeloid leukemia (AML) who can't have intensive chemotherapy. Participants must be in good physical condition, with no major heart problems, and not have had certain treatments before.Check my eligibility
What is being tested?
The trial tests the safety and best dose of iadademstat combined with azacitidine and venetoclax in AML patients. It studies how these drugs work together to inhibit cancer cell growth by targeting specific proteins that cancer cells need to survive.See study design
What are the potential side effects?
Potential side effects include reactions at the injection site, fatigue, nausea, low blood counts leading to increased infection risk or bleeding tendencies, organ dysfunction due to drug toxicity, and possible heart issues detected by echocardiography.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ start of iada (day 1 of the monotherapy lead in, cycle 0 day 1 to the end of cycle 1 (each cycle is 28 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start of iada (day 1 of the monotherapy lead in, cycle 0 day 1 to the end of cycle 1 (each cycle is 28 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose-limiting toxicities (DLTs) within specific iadademstat (IADA) dose levels
Secondary outcome measures
Incidence of treatment-emergent grade ≥ 3 adverse events (AEs)
Percentage of efficacy-evaluable participants achieving an overall response (ORR)
Percentage of efficacy-evaluable participants achieving composite complete remission (cCR)
Trial Design
4Treatment groups
Experimental Treatment
Group I: Treatment Dose Level 2 (iadademstat, azacitidine, venetoclax)Experimental Treatment8 Interventions
Iadademstat (150 mcg, 5+2 days, 2 out of 4 weeks per cycle), Venetoclax (400 mg, day 1-21), Azacitidine (75 mg/m2, day 1-7)
Patients receive iadademstat PO 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 and azacitidine SC QD days 1-7. Patients with CR, CRh, CRi, or 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 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or 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.
Group II: Treatment Dose Level 1 (iadademstat, azacitidine, venetoclax)Experimental Treatment8 Interventions
Iadademstat (100 mcg, 5+2 days, 2 out of 4 weeks per cycle), Venetoclax (400 mg, day 1-21), Azacitidine (75 mg/m2, day 1-7)
Patients receive iadademstat PO 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 and azacitidine SC QD days 1-7. Patients with CR, CRh, CRi, or 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 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or 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.
Group III: Treatment Dose Level -2(iadademstat, azacitidine, venetoclax)Experimental Treatment8 Interventions
Iadademstat (75 mcg, 5+2 days, 2 out of 4 weeks per cycle), Venetoclax (400 mg, day 1-7), Azacitidine (50 mg/m2, day 1-7)
Patients receive iadademstat PO 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 and azacitidine SC QD days 1-7. Patients with CR, CRh, CRi, or 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 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or 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.
Group IV: Treatment Dose Level -1 (iadademstat, azacitidine, venetoclax)Experimental Treatment8 Interventions
Iadademstat (75 mcg, 5+2 days, 2 out of 4 weeks per cycle), Venetoclax (400 mg, day 1-14), Azacitidine (75 mg/m2, day 1-7)
Patients receive iadademstat PO 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 and azacitidine SC QD days 1-7. Patients with CR, CRh, CRi, or 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 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1440
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Biospecimen Collection
2004
Completed Phase 2
~1700
Venetoclax
2019
Completed Phase 3
~1990
Echocardiography
2013
Completed Phase 4
~11670
Find a Location
Who is running the clinical trial?
Oregon Health and Science UniversityOTHER
975 Previous Clinical Trials
7,386,188 Total Patients Enrolled
OHSU Knight Cancer InstituteLead Sponsor
230 Previous Clinical Trials
2,090,702 Total Patients Enrolled
Oryzon Genomics S.A.Industry Sponsor
4 Previous Clinical Trials
272 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available vacancies for potential participants in this research study?
"As per clinicaltrials.gov, the current status of this study does not involve patient recruitment. The trial was initially listed on 5/8/2024 and last revised on 4/4/2024. Despite this specific trial being closed for enrollment, there are currently 1683 other ongoing studies seeking participants."
Answered by AI
Is there any potential harm associated with the administration of Treatment Dose Level -2 (iadademstat, azacitidine, venetoclax) on individuals' well-being?
"The safety assessment conducted by our team at Power rates the treatment dose level -2 (consisting of iadademstat, azacitidine, venetoclax) as a 1. This score reflects the Phase 1 trial status and indicates that there is minimal data supporting both safety and efficacy."
Answered by AI
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