NCT07301138

BEBT-908 Plus Chemotherapy Treatment for CR MRD-Positive MEF2D-Rearranged and Pre-B Acute Lymphoblastic Leukemia Patients

A Prospective Study of BEBT-908 in Combination With Chemotherapy for Patients With MEF2D-Rearranged and Pre-B Acute Lymphoblastic Leukemia in Complete Remission With Minimal Residual Disease Positivity

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

MEF2D-rearranged and pre-B acute lymphoblastic leukemia patients achieving CR after chemotherapy and have MRD+ will be given BEBT-908 (12.3 mg/m2) combined with Mini-Hyper-CVD and Mini-MTX/Ara-C chemotherapy for two cycles. After two cycles, If MRD negativity is achieved and the patient is eligible for transplantation, hematopoietic stem cell transplantation will be performed; if MRD negativity is achieved but the patient is not suitable for transplantation, an additional six courses of BEBT-908-based combination chemotherapy will be given. Patients who fail to reach MRD negativity will be withdrawn from the study. A total of 23 patients will be enrolled

Conditions

• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	BEBT-908	BEBT-908 for Injection, dosage of administration: 12.3mg/m2，frequency and duration of administration: on the 1st,3rd,5th,8th,10th and 12th days of each cycle, and 28 days as a cycle.
DRUG	Cyclophosphamide	Cyclophosphamide Injection, dosage of administration: 150 mg/m2 every 12 hours on days 1 to 3 of odd cycles, and 28 days as a cycle.
DRUG	Vincristine	Vincristine Injection, dosage of administration: 1.4mg/m2 on day 4 and 11 of odd cycles, and 28 days as a cycle.
DRUG	Dexamethasone	Dexamethasone Injection, dosage of administration: 20 mg per day on days 1 to 4 and 11 to 14 of odd cycles, and 28 days as a cycle.
DRUG	Methotrexate	Methotrexate Injection, dosage of administration: 1g/m2 on day 1 of even cycles, and 28 days as a cycle.
DRUG	Cytarabine	Cytarabine Injection, dosage of administration: 0.5 g/m2 given every 12 hours on day 2 and 3 of even cycles, and 28 days as a cycle.

Timeline

• Start date: 2025-12-15
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2025-12-24
• Last updated: 2025-12-24

Locations

1 site across 1 country: China