NCT07203352

Efficacy of Targeted Drugs Combined With Chemotherapy in the Treatment of T-ALL

Efficacy and Safety of Targeted Drugs Combined With Chemotherapy in the Treatment of Patients With Newly Diagnosed Acute T-lymphocytic Leukemia

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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 form, patients who met the inclusion/exclusion criteria were randomly assigned to the treatment group and the control group at a ratio of 1:1. Both groups of subjects received standard induction chemotherapy in the first course. Patients in the treatment group would receive corresponding targeted drug combined chemotherapy based on bone marrow PCR testing, while patients in the control group would receive standard chemotherapy. Both the treatment group and the control group would select subsequent treatments based on the chemotherapy efficacy of the subjects. Each subject would undergo regular bone marrow examinations and other evaluations for the underlying disease on a regular basis.

Conditions

• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	targeted drug	Patients randomly assigned to the control group will receive standard chemotherapy treatment, but they cannot use targeted drugs in combination.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.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-12-01
• Completion: 2026-12-30
• First posted: 2025-10-02
• Last updated: 2025-10-02

Locations

1 site across 1 country: China