RecruitingPhase 3NCT07203352

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


Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

154 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new combination of targeted drugs and chemotherapy for adults with a rare and aggressive blood cancer called T-cell acute lymphoblastic leukemia (T-ALL). The goal is to find more effective treatment options for people who have just been diagnosed and have not yet received any treatment. **You may be eligible if...** - You are 18 or older and have been newly diagnosed with T-ALL based on bone marrow testing - You have never received any treatment for leukemia before - Your overall health and ability to function is rated as adequate (ECOG 0–2) - Your heart, liver, and kidney function meet the required levels - You have enough bone marrow sample available for genetic testing **You may NOT be eligible if...** - You have a different type of leukemia - You have previously received any cancer treatment - You have had a stem cell or bone marrow transplant before - You have another active cancer - You have uncontrolled heart disease, severe infection, or bleeding problems - You have a known allergy to any drugs used in this study - Your heart pumping function (ejection fraction) is below 50% Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGtargeted 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.


Locations(1)

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

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NCT07203352


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