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

NCT07301138 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-12-24

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-15
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07301138 on ClinicalTrials.gov