Acute Myeloid LeukemiaPhase 2NCT07304011
Olutasidenib With Azacitidine Followed by Olutasidenib Maintenance for the Treatment of IDH1-mutated Acute Myeloid Leukemia in Patients With Prior Treatment With Venetoclax Plus a Hypomethylating Agent
A Phase 2 study testing Azacitidine and Olutasidenib in people with Acute Myeloid Leukemia, run by University of California, Davis at 2 sites in United States.
Trial summary
This phase II trial studies how well giving olutasidenib with azacitidine, followed by olutasidenib maintenance, works in treating patients with IDH1-mutated acute myeloid leukemia (AML) who have received prior treatment with venetoclax plus a hypomethylating agent (HMA-Ven). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Azacitidine and Olutasidenib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Dec 2025to 1 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically documented AML (except acute promyelocytic leukemia with the t(15;17) translocation) as defined by the World Health Organization (WHO) or International Consensus Classification criteria
- Achieved complete response (CR)/complete remission with incomplete count recovery (CRi) response to first line HMA-Ven according to the European Leukemia Net (ELN) recommendations for diagnosis as determined by investigator review
- Documented IDH1-R132 mutations (≥ 0.01%) detected in the bone marrow or blood. Mutation must be present at the time of AML diagnosis or after initiating HMA-Ven
- Receiving first-line HMA-Ven with less than or equal to 4 cycles of HMA-Ven at the time of enrollment. Participants must discontinue venetoclax (Ven) at least 1 week (or 5 half-lives, whichever is shorter) from initiating study treatment
- Candidate for standard of care azacitidine
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 50%)
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- No prior solid organ allograft
- Recovery from the non-hematologic toxic effects of prior treatment to grade ≤ 1, or baseline value according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) classification (excluding infertility or alopecia)
- Aged ≥ 18 at the time of consent
- Creatinine clearance ≥ 40 mL/min (calculated by the Cockcroft-Gault formula or measured by 24-hour urine collection)
- Serum alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN)
- Serum aspartate aminotransferase (AST) ≤ 3 × ULN
- Bilirubin ≤ 2 x ULN unless due to Gilbert's syndrome or controlled autoimmune hemolytic anemia (not requiring immunosuppressive other than ≤ 20 mg of prednisolone daily)
- Note: Patients with Gilbert's syndrome may be included if total bilirubin is ≤ 3 × ULN and direct bilirubin is ≤ 2 × ULN
- Prothrombin time (PT) or international normalized ratio (INR)/activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN
- Women of child-bearing potential, men, and their respective partners, must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose of olutasidenib
- Must sign and date the informed consent form prior to undergoing any study procedures
Who cannot join
- Prior IDH1 inhibitor (IDH1i) targeted therapy
- Prior AML therapy except for HMA-Ven
- History of a different malignancy unless they have been disease-free for at least 12 months and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with a history of other malignancies within 12 months and without any evidence of disease progression or requiring therapy may be considered, but only after consideration and approval by the Overall Principal Investigator (PI). Individuals with the following cancers are eligible if diagnosed and/or treated within the past 12 months: cervical cancer in situ, breast ductal carcinoma in situ (DCIS), and basal cell or squamous cell carcinoma of the skin
- Patients with symptomatic central nervous system (CNS) metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy
- Patients with previous allogeneic hematopoietic stem cell transplantation (HSCT) for non-AML indications, if they meet any of the following criteria: < 100 days from time of HSCT; active acute or chronic graft versus (vs.) host disease (GvHD); or receiving immunosuppressive therapy as treatment or prophylaxis against GvHD
- Note: Doses < 20 mg methylprednisolone (or its equivalent) daily are not an exclusion criterion
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- Treatment with radiation therapy or major surgery (requiring general anesthesia) within 2 weeks prior to study drug dosing
- Patients unable to swallow oral medications, or patients with gastrointestinal conditions (e.g., malabsorption, resection, etc.) deemed by the Investigator to jeopardize intestinal absorption
- Congestive heart failure (New York Heart Association Class III or IV) or unstable angina pectoris; previous history of myocardial infarction within one year prior to study entry, uncontrolled hypertension, or uncontrolled arrhythmias
- Patients with a baseline corrected QT interval by Fridericia's formula (QTcF) of > 480 msec
- Note: This criterion does not apply to patients with a bundle branch block (BBB); for participants with BBB, a cardiology consult is recommended to ensure that QTcF is not prolonged
- Concomitant medication(s) known to cause Torsades de Pointes (TdP) initiated less than the duration required to reach steady-state plasma concentration (approximately five half-lives) before first dose of study drug. Medications used as needed (PRN), e.g. Zofran, and common AML supportive care drugs (e.g. levofloxacin, azoles, etc.) are exempt
- Concurrent treatment with chronic corticosteroids except if chronic treatment with < 20 mg of methylprednisolone daily or equivalent (pulse steroids for treatment or prophylaxis are allowed [e.g., for transfusion or medication reactions])
- Known history of seropositivity for HIV infection
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy (prophylactic systemic antimicrobials permitted)
- Uncontrolled disease-related metabolic disorder (e.g., hypercalcemia)
- Pregnant, breastfeeding, or planning to become pregnant while enrolled in this trial or within 90 days after the last dose of olutasidenib. Pregnant or breastfeeding
- NOTE: Breast milk cannot be stored for future use while the mother is being treated on study)
- Plans to donate sperm or conceive a child through intercourse while enrolled in this trial or within 90 days after the last dose of olutasidenib
- Unwillingness or inability to comply with procedures either required in this protocol or considered standard of care
- Medical, uncontrolled disease-related metabolic disorder, psychiatric, cognitive, or other conditions that may, in the opinion of the investigator, compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol, or complete the study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
UCI Health Chao Family Comprehensive Cancer Center
Orange, California, 92868
Deepa Jeyakumar, MD, 877-827-8839, ucstudy@hs.uci.edu
Deepa Jeyakumar, MD
- Recruiting
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
Office of Clinical Research, 916-382-6970, OCRReferral@health.ucdavis.edu
Brian Jonas, MD
About this study
Official title: A Phase 2 Study of Olutasidenib in Combination With Azacitidine Followed by Olutasidenib Maintenance After Venetoclax Plus a Hypomethylating Agent Regimen (HMA-VEN) for IDH1-Mutated Acute Myeloid Leukemia (AML)
This phase II trial studies how well giving olutasidenib with azacitidine, followed by olutasidenib maintenance, works in treating patients with IDH1-mutated acute myeloid leukemia (AML) who have received prior treatment with venetoclax plus a hypomethylating agent (HMA-Ven). Olutasidenib and azacitidine may inhibit the growth of cancer cells by blocking certain enzymes required for cell growth. Maintenance therapy can help prevent or delay cancer from coming back. Olutasidenib with azacitidine followed by olutasidenib maintenance may be effective in treating patients with IDH1-mutated AML who have received prior HMA-Ven.
Read the detailed description
Participants receive olutasidenib orally (PO) twice daily (BID) on days 1-28 of each cycle and azacitidine intravenously (IV) or subcutaneously (SC) for seven days of each cycle as per schedule determined by the investigator. Cycles repeat every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive olutasidenib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and biopsy, and blood sample collection throughout the study.
After completion of study treatment, patients are followed up within 30 days and then every 4 months until withdrawal of consent, lost to follow-up, study termination, or death.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Azacitidine, Olutasidenib
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzacitidineDrug
Also called 5 AZC, 5-AC, 5-Azacitidine, 5-Azacytidine
Given IV or SC
OlutasidenibDrug
Also called FT 2102, FT-2102, FT2102, IDH1-R132 Inhibitor FT-2102
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (olutasidenib, azacitidine) | Experimental | Patients receive olutasidenib PO BID on days 1-28 of each cycle and azacitidine IV or SC for seven days of each cycle as per schedule determined by investigator. Cycles repeat every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive olutasidenib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and biopsy and blood sample collection throughout the study. Receives: Drug: Azacitidine; Drug: Olutasidenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure
Defined as the percent of patients who reached death due to acute myeloid leukemia (AML), relapse, or discontinuation of treatment due to an adverse event, at 12 months from the time of CR/CRi in patients with AML who begin first line venetoclax plus a hypomethylating agent regimen and subsequently transition to olutasidenib maintenance. The Kaplan-Meier method will be employed to summarize the duration from the initiation of study treatment to treatment failure and to report the probability of being event-free at one year. The 1-year treatment failure rate will be reported along with its 95% confidence interval.
Measured: At 12 months from complete response (CR)/complete remission with incomplete count recovery (CRi)
Median time to treatment failure
Will be reported along with its 95% confidence interval.
Measured: From CR/CRi through death due to AML, relapse, or treatment discontinuation due to adverse event, assessed up to 4 years
Secondary outcomes (5)
Incidence of adverse events (AEs)
All AEs will be listed, documenting the course, outcome, severity, and relationship to the study treatment. The proportion of participants experiencing AEs, serious adverse events, and treatment delays will be reported. Incidence rates of AEs and the proportion of participants prematurely withdrawn from the study due to AEs will be reported. AEs will be classified by severity and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Measured: Up to 30 days after last dose of study drug
Relapse free survival
Relapse categorized as CR, complete remission with partial hematologic recovery (CRh), or CRi, will be determined according to the European Leukemia Net (ELN) guidelines. Will be summarized using the Kaplan-Meier method. Will be reported along with its 95% confidence interval.
Measured: From the date of remission until the occurrence of hematologic relapse or death from any cause, assessed up to 4 years
Duration of remission
Remission categorized as CR, CRh, or CRi, will be determined according to the ELN guidelines. Will be summarized using the Kaplan-Meier method. Will be reported along with its 95% confidence interval.
Measured: From the achievement of remission to hematologic relapse or death due to AML, assessed up to 4 years
Overall survival
Will be summarized using the Kaplan-Meier method. Will be reported along with its 95% confidence interval.
Measured: From remission until death due to any cause, assessed up to 4 years
Rate of allogeneic hematopoietic cell transplants
The proportion of patients receiving allogeneic hematopoietic cell transplants during the study period will be reported, along with its 95% confidence interval.
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start17 Dec 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Brian Jonas, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304011
- Sponsor's protocol ID
- UCDCC320
- Other IDs
- NCI-2025-09023, UCDCC320, P30CA093373
- Status last verified
- Oct 2026
- First submitted
- 23 Dec 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Olutasidenib in Combination With Azacitidine Followed by Olutasidenib Maintenance After Venetoclax Plus a Hypomethylating Agent Regimen (HMA-VEN) for IDH1-Mutated Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT07304011
- Acronym / sponsor ID
- UCDCC320
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well giving olutasidenib with azacitidine, followed by olutasidenib maintenance, works in treating patients with IDH1-mutated acute myeloid leukemia (AML) who have received prior treatment with venetoclax plus a hypomethylating agent (HMA-Ven). Olutasidenib and azacitidine may inhibit the growth of cancer cells by blocking certain enzymes required for cell growth. Maintenance therapy can help prevent or delay cancer from coming back. Olutasidenib with azacitidine followed by olutasidenib maintenance may be effective in treating patients with IDH1-mutated AML who have received prior HMA-Ven.
Detailed description
Participants receive olutasidenib orally (PO) twice daily (BID) on days 1-28 of each cycle and azacitidine intravenously (IV) or subcutaneously (SC) for seven days of each cycle as per schedule determined by the investigator. Cycles repeat every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive olutasidenib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and biopsy, and blood sample collection throughout the study.
After completion of study treatment, patients are followed up within 30 days and then every 4 months until withdrawal of consent, lost to follow-up, study termination, or death.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (olutasidenib, azacitidine) | Experimental | Drug: Azacitidine, Drug: OlutasidenibPatients receive olutasidenib PO BID on days 1-28 of each cycle and azacitidine IV or SC for seven days of each cycle as per schedule determined by investigator. Cycles repeat every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive olutasidenib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and biopsy and blood sample collection throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Pathologically documented AML (except acute promyelocytic leukemia with the t(15;17) translocation) as defined by the World Health Organization (WHO) or International Consensus Classification criteria
- Achieved complete response (CR)/complete remission with incomplete count recovery (CRi) response to first line HMA-Ven according to the European Leukemia Net (ELN) recommendations for diagnosis as determined by investigator review
- Documented IDH1-R132 mutations (≥ 0.01%) detected in the bone marrow or blood. Mutation must be present at the time of AML diagnosis or after initiating HMA-Ven
- Receiving first-line HMA-Ven with less than or equal to 4 cycles of HMA-Ven at the time of enrollment. Participants must discontinue venetoclax (Ven) at least 1 week (or 5 half-lives, whichever is shorter) from initiating study treatment
- Candidate for standard of care azacitidine
Key exclusion criteria (21 listed)
- Prior IDH1 inhibitor (IDH1i) targeted therapy
- Prior AML therapy except for HMA-Ven
- History of a different malignancy unless they have been disease-free for at least 12 months and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with a history of other malignancies within 12 months and without any evidence of disease progression or requiring therapy may be considered, but only after consideration and approval by the Overall Principal Investigator (PI). Individuals with the following cancers are eligible if diagnosed and/or treated within the past 12 months: cervical cancer in situ, breast ductal carcinoma in situ (DCIS), and basal cell or squamous cell carcinoma of the skin
- Patients with symptomatic central nervous system (CNS) metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy
- Patients with previous allogeneic hematopoietic stem cell transplantation (HSCT) for non-AML indications, if they meet any of the following criteria: < 100 days from time of HSCT; active acute or chronic graft versus (vs.) host disease (GvHD); or receiving immunosuppressive therapy as treatment or prophylaxis against GvHD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzacitidineAlso: 5 AZC, 5-AC, 5-Azacitidine, 5-AzacytidineGiven IV or SC | Drug | Treatment (olutasidenib, azacitidine) |
| OlutasidenibAlso: FT 2102, FT-2102, FT2102, IDH1-R132 Inhibitor FT-2102Given PO | Drug | Treatment (olutasidenib, azacitidine) |
Primary outcome
Treatment failure
Time frame: At 12 months from complete response (CR)/complete remission with incomplete count recovery (CRi)
Defined as the percent of patients who reached death due to acute myeloid leukemia (AML), relapse, or discontinuation of treatment due to an adverse event, at 12 months from the time of CR/CRi in patients with AML who begin first line venetoclax plus a hypomethylating agent regimen and subsequently transition to olutasidenib maintenance. The Kaplan-Meier method will be employed to summarize the duration from the initiation of study treatment to treatment failure and to report the probability of being event-free at one year. The 1-year treatment failure rate will be reported along with its 95% confidence interval.
Median time to treatment failure
Time frame: From CR/CRi through death due to AML, relapse, or treatment discontinuation due to adverse event, assessed up to 4 years
Will be reported along with its 95% confidence interval.
5 secondary outcomes
Incidence of adverse events (AEs)
Time frame: Up to 30 days after last dose of study drug
Relapse free survival
Time frame: From the date of remission until the occurrence of hematologic relapse or death from any cause, assessed up to 4 years
Duration of remission
Time frame: From the achievement of remission to hematologic relapse or death due to AML, assessed up to 4 years
Overall survival
Time frame: From remission until death due to any cause, assessed up to 4 years
Rate of allogeneic hematopoietic cell transplants
Time frame: Up to 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brian Jonas, MD principal investigator
University of California, Davis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azacitidine and Olutasidenib in people with Acute Myeloid Leukemia, run by University of California, Davis at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Office of Clinical Research (916-382-6970, OCRReferral@health.ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure (time frame: At 12 months from complete response (CR)/complete remission with incomplete count recovery (CRi)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.