Actively Recruiting
Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for Intensive Induction Chemotherapy
Led by Justin Watts, MD · Updated on 2026-04-16
16
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
J
Justin Watts, MD
Lead Sponsor
R
Rigel Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is as follows: 1. Determine whether people receiving the combination treatment of olutasidenib, venetoclax, and azacitidine have the same, more, or fewer side effects compared to the usual chemotherapy treatment that people with this condition receive. 2. Determine how well the combination treatment of olutasidenib, venetoclax, and azacitidine works compared to the usual chemotherapy treatment that people with this condition receive.
CONDITIONS
Official Title
Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for Intensive Induction Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult male or female aged 18 to 75 years eligible for intensive induction chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Confirmed newly diagnosed acute myeloid leukemia with IDH1 R132 mutation
- Secondary AML allowed including prior hypomethylating agents exposure
- Adequate organ function: AST and ALT 3 times upper limit of normal (ULN) or 5 times ULN if leukemic involvement
- Bilirubin 2 ULN or 3 ULN with Gilbert Syndrome or leukemic involvement
- Creatinine clearance 30 mL/min or serum creatinine 1.5 times ULN
- At least 7 days since prior treatment for antecedent hematologic disorder
- Allowed use of intrathecal chemotherapy for CNS leukemia or hydroxyurea for proliferative disease
- Recovery to Grade 1 or baseline of non-hematologic toxicities from prior treatment
- Baseline QTcF 480 msec or cardiology consult if bundle branch block present
- Women of childbearing potential with negative pregnancy tests before treatment
- Agree to use highly effective contraception during and 3 months after study
- Agree to refrain from egg/ova or sperm donation during and 3 months after study
- Willing and able to comply with study requirements and provide informed consent
You will not qualify if you...
- Relapsed or refractory acute myeloid leukemia
- Favorable risk AML except nucleophosmin 1 (NPM1) mutated AML
- Acute promyelocytic leukemia (APL)
- Positive FLT3-ITD mutation
- Active central nervous system involvement by leukemia
- Age below 18 or above 75 years
- Pregnant or breastfeeding female participants
- Planning pregnancy or fathering a child during or within 3 months after study
- Known allergy or hypersensitivity to study drugs or excipients
- Previous therapy with olutasidenib, ivosidenib, venetoclax, or other BCL-2/IDH1 inhibitors
- Unstable medical conditions such as uncontrolled infections or severe psychiatric illness
- Recent use of strong CYP3A inhibitors or inducers without adequate washout
- Active graft-versus-host disease requiring immunosuppression beyond prednisone 10 mg daily
- Concurrent active malignancy under treatment
- Active hepatitis B, hepatitis C, or HIV infection with detectable viral load
- Major surgery within 28 days prior to treatment without recovery
- Impaired decision-making capacity
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
J
Justin Watts, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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