NCT07203352 Efficacy of Targeted Drugs Combined With Chemotherapy in the Treatment of T-ALL
| NCT ID | NCT07203352 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Nanfang Hospital, Southern Medical University |
| Condition | Acute Lymphoblastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 154 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 154 participants in total. It began in 2025-10-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Qifa Liu
PRINCIPAL INVESTIGATOR
Nanfang Hospital, Southern Medical University
Frequently Asked Questions
Who can join the NCT07203352 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Acute Lymphoblastic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07203352 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 154 participants.
Is NCT07203352 currently recruiting?
Yes, NCT07203352 is actively recruiting participants. Contact the research team at 18956985366@163.com for enrollment information.
Where is the NCT07203352 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07203352 clinical trial?
NCT07203352 is sponsored by Nanfang Hospital, Southern Medical University. The principal investigator is Qifa Liu at Nanfang Hospital, Southern Medical University. The trial plans to enroll 154 participants.
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