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

NCT07203352 | Recruiting Phase 3

• 1 other identifier: NFEC-2025-241
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• Overall survival

  2-year

Secondary Outcomes (2)

• Progress-free survival

  2-year

• Cumulative incidence of relapse

  2-year

Study Arms (2)

experimental group

EXPERIMENTAL

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.

Drug: targeted drug

control group

NO INTERVENTION

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

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.

experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Qifa Liu

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivia Jiang

CONTACT

02061641611; 18956985366@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 2, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

CN (1)