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

NCT ID: NCT07203352

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-12-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

targeted drug

Intervention Type: 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.

control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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;

2. The subjects must have never received anti-leukemia treatment before;

3. Age ≥ 18 years old, gender not restricted;

4. The subjects' Eastern Cooperative Oncology Group (ECOG) performance status score is 0-2;

5. The subjects or their legal representatives must provide written informed consent before undergoing the special examinations or procedures of the study.

Exclusion Criteria

1. Classified as other types of leukemia according to the WHO 2016 classification;

2. Previously received systemic or local treatments including chemotherapy;

3. Previously underwent hematopoietic stem cell transplantation;

4. Had other tumors in addition to leukemia;

5. Had uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, severe infectious diseases, etc.;

6. Patients with a history of allergic reactions to any drugs in this research protocol;

7. Left ventricular ejection fraction ≤ 50%;

8. 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;

9. Other concurrent and uncontrolled medical conditions that the researcher considers will affect the patient's participation in the study;

10. Psychiatric patients or other patients known or suspected to be unable to fully comply with the study protocol;

11. Pregnant or lactating women;

12. HIV-infected individuals.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qifa Liu

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Locations

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Olivia Jiang

Role: CONTACT

18956985366@163.com

02061641611

Facility Contacts

Li Xuan

Role: primary

356135708@qq.com

15521251270

Other Identifiers

NFEC-2025-241

Identifier Type: -

Identifier Source: org_study_id