Acute Lymphocytic Leukemia
Conditions
Interventions
Experimental group:Lisaftoclax combined with the CALGB 10403 pediatric-inspired chemotherapy regimen for the treatment of newly diagnosed Philadelphia chromosome-negative Acute Lymphoblastic Leukemia
Maintenance therapy (24 months total), employing the POMP regimen (Mercaptopurine + Methotrexate), with patients having the option to self-decide on combining it with Lisaftoclax (400 mg daily, 21 day
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
14 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Age: 14 to 60 years old; 2.Diagnosis of Philadelphia chromosome-negative precursor B-cell or T-cell Acute Lymphoblastic Leukemia (ALL) confirmed by bone marrow morphology and immunophenotyping, according to the WHO diagnostic criteria; 3.Newly diagnosed ALL, with no prior anti-leukemic therapy except for corticosteroids/hydroxyurea used for controlling hyperleukocytosis, superior vena cava syndrome, or other emergencies. One prior intrathecal chemotherapy for prophylaxis is allowed; 4.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2; 5.Adequate organ function:Total bilirubin 50 mL/min.Left ventricular ejection fraction (LVEF) > 40%.Coagulation profile within normal limits. 6.Ability to understand and sign a written informed consent form, demonstrate good compliance, and be able to complete the entire treatment course and follow-up.
Exclusion criteria
Exclusion criteria: 1.Ph-positive ALL (BCR-ABL1 fusion gene positive), Mixed-phenotype acute leukemia (MPAL), or Chronic myeloid leukemia in lymphoid blast crisis; 2.Any prior chemotherapy for ALL or prior treatment with any BCL-2 inhibitor (with the exception of dexamethasone and hydroxyurea); 3.Known hypersensitivity to Lisaftoclax, or any component of the chemotherapy agents (cyclophosphamide, vindesine, dexamethasone, methotrexate, cytarabine) or their excipients; 4.Relevant comorbidities: (1).Active, uncontrolled infection (e.g., sepsis, uncontrolled pneumonia, active tuberculosis) requiring systemic anti-infective therapy for >=7 days without adequate control; (2).Severe hepatic or renal insufficiency (exceeding the limits specified in the inclusion criteria); (3).Active peptic ulcer disease or bleeding diathesis (e.g., active gastrointestinal bleeding, history of intracranial hemorrhage); 5.Other: Any psychiatric illness or cognitive impairment that would compromise the patient's ability to participate in the study, or any other situation deemed by the investigator as inappropriate for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Tolerated Dose;Recommended Phase II Dose;Dose-Limiting Toxicity;Adverse Events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate;Measurable Residual Disease (MRD) Negative Rate;Duration of Response;Disease-Free Survival;Overall Survival;Treatment Completion Rate; | — |
Countries
China
Contacts
Public ContactYan Xiaojing
The First Hospital of China Medical University
Outcome results
None listed