BEBT-908 Plus Chemotherapy Treatment for CR MRD-Positive MEF2D-Rearranged and Pre-B Acute Lymphob… (NCT07301138) | Clinical Trial Compass
Not Yet RecruitingPhase 2
BEBT-908 Plus Chemotherapy Treatment for CR MRD-Positive MEF2D-Rearranged and Pre-B Acute Lymphoblastic Leukemia Patients
China23 participantsStarted 2025-12-15
Plain-language summary
This investigator-initiated, prospective, single-arm, multicenter clinical trial aims to evaluate the efficacy and safety of BEBT-908 (a HDAC/PI3Kα inhibitor provided by BeBetter Med Inc ,Guangzhou, China) combined with chemotherapy in patients with MEF2D-rearranged and pre-B acute lymphoblastic leukemia who are in complete remission (CR) but remain minimal residual disease (MRD) positive.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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;
✓. Age between ≥18 and ≤75 years at screening, with no gender restrictions;
✓. Meets the diagnostic criteria for BCP-ALL (according to the 2022 WHO classification) and fulfills any one of the following conditions:
✓. Serum creatinine ≤1.5 times the upper limit of normal（ULN）；
✓. 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
✕. Known allergy to the study drug or its excipients.
✕. Presence of severe and/or uncontrolled infection.
✕. 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 %.
✕. Primary central nervous system diseases, including cerebrovascular accident, intracranial infection, etc., within six months before screening.
What they're measuring
1
MRD negativity rate
Timeframe: At the end of Cycle 2 of BEBT-908 combined chemotherapy treatment (each cycle is 28 days)
. Severe primary pulmonary diseases, including significant impairment of pulmonary ventilation/diffusion function, respiratory failure, etc.
✕. 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.
✕. Severe renal impairment: serum creatinine \> 1.5 × ULN; or uncorrected acute kidney injury.
✕. Acute or chronic pancreatitis, with serum amylase \> 3 × ULN.