New drug combo aims to finish off hidden leukemia cells in high-risk patients
NCT ID NCT07301138
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug called BEBT-908 combined with chemotherapy in adults with a rare, high-risk form of acute lymphoblastic leukemia (ALL) who are in remission but still have tiny amounts of cancer cells detectable. The goal is to see if the combo can clear those leftover cells and improve long-term outcomes. About 23 participants will receive the treatment at multiple hospitals in China.
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 23 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- 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 to 75 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. The subject voluntarily agrees to participate in this trial and signs the informed consent form, and is able to understand and comply with all study requirements; 2. Age between ≥18 and ≤75 years at screening, with no gender restrictions; 3. Meets the diagnostic criteria for BCP-ALL (according to the 2022 WHO classification) and fulfills any one of the following conditions: 1\) Positive for MEF2D rearrangement 2) Philadelphia chromosome negative and consistent with a Pre-B immunophenotype (according to the EGIL 1995 immunophenotyping criteria, cytoplasmic IgM+); 4. Diagnosed with BCP-ALL in complete remission but with positive minimal residual disease (MRD), defined as: achieving hematologic complete remission (CR) after treatment (bone marrow blast count \<5% by morphology) but with positive MRD (MRD ≥10-⁴, as detected by flow cytometry and/or PCR); 5. ECOG performance status score of 0-2 at screening; 6. Expected survival is more than 3 months. 7. Satisfactory organ function, meeting the following criteria: 1. Serum creatinine ≤1.5 times the upper limit of normal(ULN); 2. Left ventricular ejection fraction (LVEF) \>50%; 3)Total bilirubin ≤2 times ULN;Alanine aminotransferase (ALT) ≤3 times ULN; Aspartate aminotransferase (AST) ≤3 times ULN Exclusion Criteria: 1. Known allergy to the study drug or its excipients. 2. Presence of severe and/or uncontrolled infection. 3. Severe cardiac disease, including: heart failure classified as New York Heart Association (NYHA) functional class III or IV; history of acute myocardial infarction within 6 months prior to screening; uncontrolled arrhythmias or electrophysiological abnormalities such as sick sinus syndrome, third degree atrioventricular block, QTc \> 480 ms, ventricular tachycardia, persistent atrial fibrillation with rapid ventricular response, etc.; or severe structural cardiac abnormalities on echocardiography or left ventricular ejection fraction (LVEF) \< 50 %. 4. Primary central nervous system diseases, including cerebrovascular accident, intracranial infection, etc., within six months before screening. 5. Severe primary pulmonary diseases, including significant impairment of pulmonary ventilation/diffusion function, respiratory failure, etc. 6. Severe hepatic impairment: total bilirubin (TB), gamma glutamyl transferase (γGT), ALT, or AST \> 3 times ULN at baseline or after hepatoprotective therapy; or conditions such as severe hepatitis, cirrhosis, etc. 7. Severe renal impairment: serum creatinine \> 1.5 × ULN; or uncorrected acute kidney injury. 8. Acute or chronic pancreatitis, with serum amylase \> 3 × ULN. 9. Pregnancy or lactation. 10. History of other prior malignancies that may affect protocol compliance or interpretation of study results. 11. Diagnosed major psychiatric disorder or predisposition to psychiatric illness that would significantly impair the ability to participate in the clinical study. 12. Any other condition deemed by the investigator as unsuitable for study enrollment.
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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, Shanghai Municipality, 200025, China
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