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Recruiting NCT07203352

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

Phase III Interventional Acute Lymphoblastic Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: targeted drug.
Who it may be relevant to
Registry conditions: Acute Lymphoblastic Leukemia. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Overall survival [Time frame: 2-year]
Secondary outcome measures (2)
  • Progress-free survival [Time frame: 2-year]
  • Cumulative incidence of relapse [Time frame: 2-year]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Department of Hematology,Nanfang Hospital, Southern Medical University — Guangzhou

Identifiers

NCT: NCT07203352 · NFEC-2025-241

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗