Study on the Efficacy and Safety of the TmBU Conditioning Regimen in High-risk or Relapsed/Refractory Acute Leukemia

Launched by THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · Feb 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach called the TmBU conditioning regimen for patients with high-risk or relapsed acute leukemia, specifically Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL). The goal is to see how effective and safe this treatment is when given before a stem cell transplant, which is a procedure that helps restore healthy blood cells. Researchers will be tracking how many patients experience a relapse of their leukemia after two years, as well as their overall survival and how well they remain free from disease progression.

To participate in this trial, patients must be between 15 and 65 years old and have a confirmed diagnosis of AML or ALL that fits certain criteria, such as being high-risk or having previously not responded to treatment. Participants will receive close monitoring and care throughout the study to ensure their safety and well-being. It's important to note that individuals with certain health conditions, previous cancers, or active infections may not be eligible to join. If you or someone you know is considering this study, it could be a valuable opportunity to explore new treatment options for leukemia.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Confirmed diagnosis of AML or ALL according to WHO 2022 guideline criteria, with indications for allo-HSCT list below:
• • 1. Relapsed/primary refractory (definitions refer to NCCN 2025) or genetic high-risk group AML at diagnosis (risk stratification refers to ELN 2022)
• • 2. High-risk at diagnosis (risk stratification refers to ELN 2022) or MRD positive before transplantation B-ALL
• • 3. Confirmed diagnosis of T-ALL
• • 4. History of central nervous system leukemia (CNSL) or histopathologically confirmed extramedullary manifestation (EMD) during the course of the AML or ALL
• • Age 15-65 years old (≤ 65 years old)
• • HCT-CI score \< 2 points ECOG 0-2 points
• * Adequate organ function:
• • 1. Cardiac NYHA grade ≤ 2, left ventricular ejection fraction ≥55%
• • 2. Creatinine clearance ≥ 50ml/min
• • 3. ALT and AST ≤ 2.5 times the upper limit of the normal range, and total bilirubin ≤ 1.5 times the upper limit of the normal range
• • 4. Oxygen saturation \> 92% without oxygen
• • Expected survival time ≥ 3 months
• • Ability to understand and voluntarily sign the informed consent form
• Exclusion Criteria:
• • With other malignant tumors and have received any treatment for this tumor within the past 3 years
• • Previous or current other CNS disease (such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis) or any CNS-related autoimmune disease
• • HIV/Syphilis infection or uncontrolled active other infections (bacteria or fungus or virus is included)
• • With active hepatitis B or hepatitis C infection
• • Patients received cardiac angioplasty or stent implantation within 12 months before signing the informed consent form, or have symptoms requiring medical treatment for coronary heart disease
• • With primary immunodeficiency or active autoimmune disease
• • Previous history of severe immediate hypersensitivity reactions to any of the drugs to be used in this study
• • Received a live vaccine within 6 weeks prior to screening
• • Pregnant, lactating females and patients of childbearing potential who are unwilling to use contraception
• • Inability to cooperate with the requirements of study, treatment and monitoring due to psychiatric illness or other conditions
• • Patients not suitable for the study according to the investigator's assessment