Status:
RECRUITING
Efficacy of Targeted Drugs Combined With Chemotherapy in the Treatment of T-ALL
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This prospective, randomized, controlled trial evaluates the efficacy and safety of a new targeted drug combined with chemotherapy versus standard chemotherapy alone. Eligible patients were randomized...
Detailed Description
This study is a prospective, randomized, controlled clinical trial aimed at evaluating the efficacy and safety of the new targeted drug combined with chemotherapy. After signing the informed consent f...
Eligibility Criteria
Inclusion
- The subjects were diagnosed with acute T-lymphocytic leukemia (according to the 2016 WHO classification) based on their bone marrow pathology and hematology, and sufficient bone marrow samples were available for PCR analysis;
- The subjects must have never received anti-leukemia treatment before;
- Age ≥ 18 years old, gender not restricted;
- The subjects' Eastern Cooperative Oncology Group (ECOG) performance status score is 0-2;
- The subjects or their legal representatives must provide written informed consent before undergoing the special examinations or procedures of the study.
Exclusion
- Classified as other types of leukemia according to the WHO 2016 classification;
- Previously received systemic or local treatments including chemotherapy;
- Previously underwent hematopoietic stem cell transplantation;
- Had other tumors in addition to leukemia;
- Had uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, severe infectious diseases, etc.;
- Patients with a history of allergic reactions to any drugs in this research protocol;
- Left ventricular ejection fraction ≤ 50%;
- Laboratory test values at screening (unless caused by leukemia): ALT or AST higher than twice the upper limit of normal, AKP and bilirubin higher than 1.5 times the upper limit of normal, creatinine level higher than 1.5 times the upper limit of normal;
- Other concurrent and uncontrolled medical conditions that the researcher considers will affect the patient's participation in the study;
- Psychiatric patients or other patients known or suspected to be unable to fully comply with the study protocol;
- Pregnant or lactating women;
- HIV-infected individuals.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT07203352
Start Date
October 1 2025
End Date
December 30 2026
Last Update
October 2 2025
Active Locations (1)
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1
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515