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NOT YET RECRUITING
NCT07301138
PHASE2

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

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

23

Start Date

2025-12-15

Completion Date

2028-12-31

Last Updated

2025-12-24

Healthy Volunteers

No

Interventions

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.

Locations (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China