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Efficacy and Safety of Targeted Drugs Combined With Chemotherapy in the Treatment of Patients With Newly Diagnosed Acute T-lymphocytic Leukemia
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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 1:1 to either the treatment or control group.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• 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.
Locations
Other Locations
China
Department of Hematology,Nanfang Hospital, Southern Medical University
RECRUITING
Guangzhou
Contact Information
Primary
Olivia Jiang
18956985366@163.com
02061641611
Time Frame
Start Date:2025-10-01
Estimated Completion Date:2026-12-30
Participants
Target number of participants:154
Treatments
Experimental: experimental group
The subjects randomly assigned to the experimental group received targeted drug treatment in addition to the chemotherapy regimen during the second course. Based on the results of bone marrow PCR, subjects with molecular typing of ABL1/ABL2/PDGFRB fusion were to receive chemotherapy combined with dasatinib 100mg orally once a day; subjects with molecular typing of FLT3-ITD positive were to receive chemotherapy combined with sorafenib 400mg orally twice a day.
No_intervention: control group
Patients randomly assigned to the control group will receive standard chemotherapy treatment, but they cannot use targeted drugs in combination.