NCT07203352RecruitingPhase 3
Efficacy of Targeted Drugs Combined With Chemotherapy in the Treatment of T-ALL
Efficacy and Safety of Targeted Drugs Combined With Chemotherapy in the Treatment of Patients With Newly Diagnosed Acute T-lymphocytic Leukemia
Source: ClinicalTrials.gov · Last updated 2 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 154 (estimated)
- First submitted
- 23 Sept 2025
- Start date
- Oct 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Diseases
- Acute lymphoblastic leukaemia
- NCT number
- NCT07203352
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 154
- From Oct 2025 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously received systemic or local treatments including chemotherapy;
- Previously underwent hematopoietic stem cell transplantation;
- Other concurrent and uncontrolled medical conditions that the researcher considers will affect the patient's participation in the study;
Other illness
- 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;
- Psychiatric patients or other patients known or suspected to be unable to fully comply with the study protocol;
- HIV-infected individuals.
Lab values
- 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
- Classified as other types of leukemia according to the WHO 2016 classification;
- Had other tumors in addition to leukemia;
- Pregnant or lactating women;
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Hematology,Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.