A Phase 2 interventional study of Ivosidenib, Sonrotoclax, Chidamide in Acute Myeloid Leukemia, sponsored by First Affiliated Hospital of Zhejiang University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by First Affiliated Hospital of Zhejiang University · Phase 2, Interventional, and Treatment
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Among 16 studies in Leukemia, Myeloid, Acute by First Affiliated Hospital of Zhejiang University — 15 open to participants now, 15 under way, 2 of them phase 3. Leukemia, Myeloid, Acute · First Affiliated Hospital of Zhejiang University.
Among the 16 studies in Leukemia, Myeloid, Acute by First Affiliated Hospital of Zhejiang University, this one is the 12th largest by planned enrollment, is one of 5 that started in 2026, is one of 9 in phase 2, reaches primary completion later than 11 of the 14 other live ones, and was the 16th registered.
3,668 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.
Browse Leukemia, Myeloid, Acute studies →15 of the 16 studies in Leukemia, Myeloid, Acute by First Affiliated Hospital of Zhejiang University are open now, in 1 country. Recruiting first, the newest first:
First Affiliated Hospital of Zhejiang University · Sites in China
Ages 18–59
First Affiliated Hospital of Zhejiang University · Sites in China
Ages 18–75
First Affiliated Hospital of Zhejiang University · Sites in China
Ages 18+
First Affiliated Hospital of Zhejiang University · Sites in China
Ages 12–60
First Affiliated Hospital of Zhejiang University · Sites in China
Ages 18+
By country, each count listing its studies:
Of the 625 Leukemia, Myeloid, Acute studies recruiting now, 363 (58%) set no upper age limit and 222 (36%) stop at 75 or younger; 145 take children under 18; 29 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 11 · Phase 3 2
First in 2022; this study’s year is marked. 5 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 40 across 3,006 interventional studies indexed under Leukemia, Myeloid, Acute.
Median enrollment 63 across the 16 interventional studies. Of the 1 that completed or were terminated, 0 (0%) have results posted.
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First Affiliated Hospital of Zhejiang University is the lead sponsor of 264 studies on the registry; 145 are open to participants now.
4 of the studies in Leukemia, Myeloid, Acute by First Affiliated Hospital of Zhejiang University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07198867First Affiliated Hospital of Zhejiang UniversityA Study of A-CAR028 Treatment in Subjects With Relapsed or Refractory Acute Myeloid Leukemia | 2026-12-30 |
| NCT06621212First Affiliated Hospital of Zhejiang UniversityMitoxantrone Hydrochloride Liposome, Standard-dose of Cytarabine and Venetoclax in the Treatment of R/R AML | 2026-12-31 |
| NCT07172204First Affiliated Hospital of Zhejiang UniversityAlternating Regimen of VA and Low-dose CHA in the Treatment of Unfit Newly Diagnosed AML | 2027-07-31 |
| NCT07183878First Affiliated Hospital of Zhejiang UniversityVenetoclax-Enhanced BUCY vs. Standard BUCY Conditioning in High-Risk AML and MDS Patients Undergoing Allo-HSCT (Ven-BUCY Study) | 2027-08-20 |
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Among the 16 studies in Leukemia, Myeloid, Acute by First Affiliated Hospital of Zhejiang University, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This prospective, multicenter, exploratory clinical study is designed to evaluate the efficacy and safety of an all-oral combination of ivosidenib, sonrotoclax, and chidamide in adults with newly diagnosed acute myeloid leukemia (AML) harboring an IDH1 R132 mutation.
Approximately 30 participants aged 18 years or older will be enrolled. Eligible participants must have previously untreated AML with a confirmed IDH1 R132 mutation and adequate heart, liver, and kidney function. Ivosidenib targets the abnormal IDH1 protein, sonrotoclax blocks BCL-2, a protein that helps leukemia cells survive, and chidamide affects gene regulation and may increase the sensitivity of leukemia cells to treatment. The study hypothesis is that combining these three medicines may produce deep and durable remissions with an acceptable safety profile while providing a treatment that can be taken entirely by mouth.
Treatment will be given in 28-day cycles. During induction treatment, all participants will receive oral ivosidenib, sonrotoclax, and chidamide. In the initial exploratory stage, participants will be assigned in a 1:1:1 ratio to one of three induction schedules. The schedules differ in the planned duration of sonrotoclax and chidamide treatment. A bone marrow examination will be performed on Day 10 or Day 14, depending on the assigned schedule, to determine whether sonrotoclax and/or chidamide should be continued through Day 28. Early remission results, adverse events, and overall tolerability will be reviewed to select a recommended induction schedule for the expansion stage.
Participants who achieve a response will receive at least three 28-day cycles of consolidation treatment with the three-drug combination. Treatment duration may be shortened or the next cycle may be delayed if blood cell counts recover slowly or other clinically important side effects occur. After consolidation, measurable residual disease (MRD) will be assessed. MRD refers to the small number of leukemia cells that may remain after treatment even when remission has been achieved. Participants who become negative for IDH1 MRD will proceed to maintenance treatment with oral ivosidenib for up to 2 years. Participants with persistent IDH1 MRD may receive additional consolidation treatment, and allogeneic hematopoietic stem cell transplantation may be considered according to the protocol and clinical assessment.
The primary outcome is the 1-year event-free survival rate, defined by whether participants remain alive without relapse or disease progression. Secondary outcomes include the composite complete remission rate after induction treatment, MRD clearance and the time to MRD clearance, relapse-free survival, overall survival, and exploratory biological markers. Safety will be evaluated by recording adverse events and monitoring blood counts, bone marrow findings, liver and kidney function, electrocardiograms, and other clinically indicated tests. Participants will be followed regularly during treatment and follow-up.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ivosidenib, Chidamide, Sonrotoclax
Drug: Ivosidenib, Sonrotoclax, Chidamide
Cohort 1: Ivosidenib 500 mg qd po d1-28; Chidamide 10 mg qd po d1-28; Sonrotoclax 40 mg d1, 80 mg d2, 160 mg d3, 320 mg d4-10 po. On d10, Sonrotoclax is adjusted according to bone marrow findings: if blasts \<5%, stop from d11; otherwise, continue 320 mg qd po to d28. Cohort 2: Ivosidenib 500 mg qd po d1-28; Chidamide 10 mg qd po d1-28; Sonrotoclax 40 mg d1, 80 mg d2, 160 mg d3, 320 mg d4-14 po. On d14, Sonrotoclax is adjusted: if blasts \<5%, stop from d15; otherwise, continue 320 mg qd po to d28. Cohort 3: Ivosidenib 500 mg qd po d1-28; Chidamide 10 mg qd po d1-14; Sonrotoclax 40 mg d1, 80 mg d2, 160 mg d3, 320 mg d4-14 po. On d14, Chidamide and Sonrotoclax are adjusted: if blasts \<5%, stop both from d15; otherwise, continue both to d28. The recommended induction schedule will be selected based on CRc, adverse events, and overall tolerability for the expansion stage.
1-Year Event-Free Survival Rate (EFS)
Event-free survival is defined as the time from the date of initiation of study treatment to the earliest occurrence of documented relapse after remission, disease progression, or death from any cause. The 1-year EFS rate will be estimated using the Kaplan-Meier method. Participants without an event will be censored at the date of their last disease assessment.
Time frame: From treatment initiation through 1 year.
Composite Complete Remission Rate After Two Cycles (CRc=CR+CRi)
After completion of two induction treatment cycles, CR and CRi will be assessed according to bone marrow morphology, peripheral blood cell counts, and the response criteria specified in the protocol. CRc is defined as CR plus CRi.
Time frame: At the end of Cycle 2（each cycle is 28 days）
Minimal Residual Disease (MRD) Negativity Rate
MRD will be dynamically assessed using multiparameter flow cytometry, quantitative PCR, and/or NGS. Flow cytometric MRD negativity is defined as \<0.01%, while molecular MRD negativity is determined according to the corresponding assay result.
Time frame: At the end of each Cycle（each cycle is 28 days），up to 2 years
Relapse-Free Survival (RFS)
RFS is defined as the time from the first achievement of CR or CRi to disease relapse or death from any cause. Patients without an event are censored at the date of the last disease assessment. RFS will be analyzed using the Kaplan-Meier method.
Time frame: up to 2 years
Overall Survival (OS)
OS is defined as the time from treatment initiation to death from any cause. Patients who remain alive at the end of the study are censored at the last date known to be alive. OS will be analyzed using the Kaplan-Meier method.
Time frame: up to 5 years
Incidence of Adverse Events and Serious Adverse Events
Adverse events and serious adverse events will be recorded according to their incidence, severity, relationship to the study drugs, and outcomes, and will be graded according to CTCAE Version 5.0.
Time frame: From day 1 of treatment to 28 days after the last dose
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared because this is an investigator-initiated exploratory study with a small sample size, and the data include sensitive clinical and genomic information. De-identified aggregate study results may be reported in publications or scientific presentations.
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2028, 23 months later.
Of 386 non-industry phase 2 interventional studies under Leukemia, Myeloid, Acute, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 108. This study's planned 23 months is below that.
Counting every sponsor, half of 443 studies reached it within 60 months; a quarter within 38 and three quarters within 104.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital of Zhejiang University →