Efficacy of Targeted Drugs Combined With Chemotherapy in the Treatment of T-ALL
Recruiting
Phase 3Interventional Study
Acute Lymphoblastic Leukemia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
154 (estimated)
Sponsor
Nanfang Hospital, Southern Medical University · Other
Who this trial is looking for
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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.
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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-leuk…
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.
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