New combo therapy aims to improve leukemia remission
NCT ID NCT07548710
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 4 times
Summary
This study tests a new drug called sonrotoclax combined with standard chemotherapy and other targeted medicines for adults newly diagnosed with acute myeloid leukemia (AML). About 205 participants will receive different treatments based on their genetic markers. The goal is to see if this combination leads to complete remission and to check for side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 205 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Newly diagnosed AML confirmed by bone marrow morphology and immunophenotyping (5th edition WHO diagnostic criteria) * Subjects with APL excluded according to fusion gene and chromosome results * ECOG performance status 0-3 * Age ≥ 18 years * White blood cell count must be \< 25 × 10⁹/L at the start of study treatment (can be reduced by leukapheresis and/or hydroxyurea) * Subjects must have adequate organ function, defined as follows: Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN), unless elevated due to leukemic organ involvement; serum total bilirubin \< 3 × ULN; higher levels are acceptable if attributable to ineffective erythropoiesis, leukemic organ involvement, or Gilbert syndrome; serum creatinine \< 3 × ULN, or estimated creatinine clearance ≥ 30 mL/min by Cockcroft-Gault formula * Written informed consent obtained from the subject or legal representative Exclusion Criteria: * FAB classification as M3, or molecularly confirmed APL * Refractory / relapsed subjects * Subjects with a history of myeloproliferative neoplasms (MPN); * Subjects with a history of chronic myeloid leukemia (CML); * Subjects with mixed phenotype acute leukemia (MPAL); * Documented central nervous system leukemia; * Hypersensitivity or allergy to any of the study drugs; * Physical conditions or organ system dysfunction that impairs the ability to swallow capsules or tablets, or significantly affects gastrointestinal function and/or absorption (including malabsorption syndrome, small bowel resection, or uncontrolled inflammatory bowel disease); * Cardiac conditions meeting any of the following:a) Long QT syndrome or QTc interval \> 480 ms;b) Second- or third-degree atrioventricular block; severe, uncontrolled arrhythmia requiring medical treatment;c) History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia, or any other treatable arrhythmia, clinically significant pericardial disease within 6 months prior to enrollment; or electrocardiographic evidence of acute ischemia or active conduction system abnormalities; * Current concurrent malignancy other than adequately controlled non-melanoma skin basal cell carcinoma, in situ breast/cervical carcinoma, or other malignancies adequately controlled without treatment for more than 6 months; * Significantly abnormal liver or renal function (serum bilirubin, AST, ALT, or serum creatinine \> 3 × upper limit of normal; excluding those deemed by the investigator to be related to AML); * Subjects who have received previous anti-AML therapies other than hydroxyurea for cytoreduction, including but not limited to BCL-2, FLT3, IDH1 inhibitors, or other investigational agents; * Coagulopathy unrelated to AML; * HIV infection, syphilis infection, HCV infection, or active HBV infection (HBsAg positive; or HBsAg negative / HBcAb positive with HBV DNA \> 1.0 × ULN); Patients with previously documented such infections who have achieved undetectable viral load or sustained viral load reduction after treatment may be enrolled at the investigator's discretion; * Other uncontrolled active infection (as judged by the investigator); * Pregnant or breastfeeding women; * Unable to understand or comply with the study protocol; * Participation in other relevant clinical studies within 30 days (excluding diagnostic studies); * Subjects deemed inappropriate for study participation by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai
RECRUITINGShanghai, Shanghai Municipality, 200025, China
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