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

Sponsor
Nanfang Hospital, Southern Medical University
Study ID
NCT07203352
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • targeted drug — 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.

Study Details

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.

Key Dates

First listed
Oct 2, 2025
Start date
Oct 1, 2025
Status verified
Sep 2025
Primary completion
Dec 1, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
154 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Overall survival [ Time Frame: 2-year ]

Central Contacts

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