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Can a new drug combo reset the immune system to beat relapsed leukemia?
NCT ID NCT07757672
First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time
Summary
This trial tests whether a combination of sonrotoclax, cladribine, and cytarabine, followed by a stem cell transplant, can improve survival in adults with relapsed or refractory acute myeloid leukemia (AML). Participants receive the chemotherapy regimen, then undergo an allogeneic stem cell transplant within weeks, and may continue sonrotoclax as maintenance. The study aims to see if this strategy improves 2-year survival and reduces relapse, while monitoring safety and side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of sonrotoclax, cladribine, and cytarabine, followed by an allogeneic stem cell transplant
- What this could lead to
- If successful, this approach could offer a path to long-term remission or even a cure for people with hard-to-treat AML.
- What could go wrong
- This is an early-phase, single-arm trial with no comparison group, so results may not be definitive. The chemotherapy and transplant carry significant risks, including infection and treatment-related mortality.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2029
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 to 65 years
- 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: * 1.Patients with a confirmed diagnosis of relapsed or refractory acute myeloid leukemia (AML) based on bone marrow morphology, immunophenotyping, and cytogenetics. * 2\. Patients who are planned to undergo allogeneic hematopoietic stem cell transplantation, including HLA-matched or HLA-mismatched related allogeneic transplantation, as well as unrelated donor transplantation. * 3\. Age between 18 and 65 years, inclusive, regardless of gender. * 4\. Eastern Cooperative Oncology Group performance status (ECOG) of 0-2. * 5\. Written informed consent must be obtained prior to the initiation of any study-related procedures. For patients aged 18 years or older, the consent form may be signed by the patient or by a direct relative. Should the patient's own signature be judged to be potentially harmful to their clinical care, consent may instead be given by a legal guardian or a direct relative. Exclusion Criteria: * 1\. Uncontrolled active infection (bacterial, fungal, or viral). * 2\. Known positive serology for human immunodeficiency virus (HIV) or active hepatitis C virus (HCV). * 3\. Psychiatric disorders or other medical conditions that preclude compliance with the study treatment and monitoring requirements. * 4\. Pregnant patients, or patients who are unwilling or unable to use adequate contraceptive measures during the treatment period. * 5\. Prior hematopoietic stem cell transplantation. * 6\. Active cardiac disease, defined as one or more of the following: History of uncontrolled or symptomatic angina pectoris; Myocardial infarction within 6 months prior to study enrollment; History of arrhythmia requiring medication or clinically significant symptomatic arrhythmia; Uncontrolled or symptomatic congestive heart failure (\> New York Heart Association \[NYHA\] class 2); Ejection fraction below the lower limit of normal; Previous coronary angioplasty or stent implantation. * 7\. Severe hepatic impairment, defined as liver function parameters (ALT, TBIL) \> 3 × upper limit of normal (ULN); or severe renal impairment, defined as serum creatinine (Cr) \> 2 × ULN, or 24-hour urine creatinine clearance \< 50 mL/min; or any other condition that, in the investigator's opinion, renders the patient unsuitable for treatment with the study drug. * 8\. Any other condition that, in the investigator's opinion, makes the patient ineligible for study participation.
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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 official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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.
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