Targeted drug plus chemotherapy for adult T-cell acute lymphoblastic leukemia

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

This trial tests whether adding a targeted drug to standard chemotherapy helps adults with T-cell acute lymphoblastic leukemia have better responses than chemotherapy alone.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 154 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Nanfang Hospital, Southern Medical University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07203352 on ClinicalTrials.gov

What this trial studies

This phase 3, randomized, controlled trial enrolls adults newly diagnosed with T-ALL and randomizes them 1:1 to receive standard chemotherapy with or without a targeted agent. All participants receive standard induction chemotherapy, and the treatment arm receives a targeted drug chosen based on bone marrow PCR testing. Patients are treatment-naïve, have ECOG performance status 0–2, and undergo regular bone marrow examinations and disease monitoring to guide subsequent therapy. The trial is conducted at Nanfang Hospital, Southern Medical University, with outcomes including response, relapse, safety, and survival compared between arms.

Who should consider this trial

Good fit: Adults (≥18) with newly diagnosed, untreated T-cell acute lymphoblastic leukemia, ECOG 0–2, and sufficient bone marrow samples for PCR who can provide informed consent and attend follow-up.

Not a fit: Patients with other leukemia types, prior systemic leukemia treatment or hematopoietic stem cell transplant, uncontrolled major comorbidities, or without an actionable PCR target are unlikely to benefit.

Why it matters

Potential benefit: If successful, adding a PCR-guided targeted drug could increase remission rates and reduce relapse for adults with T-ALL.

How similar studies have performed: Targeted agents combined with chemotherapy have improved outcomes in some ALL subtypes (for example Ph+ B-ALL), but targeted approaches in T-ALL are less well established and relatively novel.

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.

Where this trial is running

Guangzhou, Guangdong

• Department of Hematology,Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Qifa Liu — Nanfang Hospital, Southern Medical University
• Study coordinator: Olivia Jiang

Conditions Acute Lymphoblastic Leukemia