Pre-B lymphoblastic leukemia
Conditions
Interventions
Intervention group:BEBT-908 combined chemotherapy treatment
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this trial and sign the informed consent form, and be able to understand and comply with the study requirements; 2. Aged 18-75 years; both males and females are eligible; 3. Meet the diagnostic criteria for BCP-ALL (referencing the 2022 WHO classification) and satisfy at least one of the following conditions: (1) MEF2D rearrangement positive (positive by first- or second-generation gene sequencing); (2) Ph negative (confirmed by first- or second-generation gene sequencing or chromosome testing) and conforming to the Pre-B immunophenotype (referencing EGIL 1995 immunophenotyping, cytoplasmic IgM); 4. Diagnosed with complete remission and minimal residual disease-positive BCP-ALL (1) Achieved hematologic complete remission (CR) after treatment (morphology shows bone marrow blasts = 10^-4, including flow cytometry and/or PCR detection); 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 6. Expected survival time of at least 3 months; 7. Cardiac, liver, and renal function meet the following requirements: (1) Serum creatinine 50%; (3) Total bilirubin <= 2 × ULN; ALT and AST <= 3 × ULN (as judged by the investigator, if ALT and AST elevation is caused by ALL itself, ALT and AST <= 5 × ULN).
Exclusion criteria
Exclusion criteria: 1.Known allergy to the investigational drug or its excipient; 2.There are serious and/or uncontrolled infected patients; 3.Serious heart disease: heart failure according to the New York Heart Association (NYHA) functional classification of grade 3 or 4 heart failure; Or have a history of acute myocardial infarction within the 6 months prior to screening; Or uncontrolled arrhythmias and cardiac electrophysiological abnormalities such as sick sinus syndrome, third degree atrioventricular block QTc>480 ms Ventricular tachycardia, persistent rapid ventricular rate atrial fibrillation, etc; Or patients with severe abnormalities in cardiac structure or left ventricular ejection fraction3 times the upper limit of normal, as well as patients with severe hepatitis and cirrhosis; 7.Patients with severe kidney disease: serum creatinine>1.5 × ULN; Or there may be uncorrected acute kidney injury; 8.Acute and chronic pancreatitis, subjects with serum amylase levels greater than the upper limit of 3 normal values; 9.Pregnancy and lactation period; 10.Previous history of other malignant tumors that may affect protocol compliance or outcome interpretation; 11.Diagnosed with significant mental illness or a tendency towards mental illness, which will seriously affect the ability to participate in clinical research; 12.Other researchers believe that it is not suitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRD negativity rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Progress-Free Survival;Relapse-Free Survival;Safety: Hematological and non hematological toxicity; | — |
Countries
China
Contacts
Public ContactWang Jin
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed