๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 โฅ 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 โค 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.