Patients with Ph/BCR::ABL1-positive acute lymphoblastic leukemia or accelerated phase of chronic myeloid leukemia harboring the T315I mutation
Conditions
Interventions
Olverembatinib treatment group:Olverembatinib combined with the VP regimen
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age>=18 years old; 2. Ph/BCR::ABL1 ALL patients with T315I mutation; 3. Patients with acute gonorrhea of chronic myeloid leukemia can also be included; 4. Sound liver and kidney function (ALT<=3*ULN, AST<=3*ULN, total bilirubin<=3*ULN, creatinine<=3*ULN, BUN<=3*ULN); 5. Able to understand and comply with the requirements of the clinical trial protocol; 6. Sign informed consent;
Exclusion criteria
Exclusion criteria: 1.Patients who have previously received olverembatinib but failed to respond; 2.Patients who have experienced allergic reactions to olverembatinib or other drugs contained in the regimen; 3.Patients with clinically significant, uncontrolled or active cardiovascular disease, or those who need to take drugs known to potentially cause QT interval prolongation on electrocardiogram, are excluded; patients with primary hypertension who can maintain stable blood pressure with antihypertensive drugs can be enrolled; 4.During the previous treatment with TKI, there were serious cardiovascular disease conditions (including myocardial infarction, unstable angina pectoris, severe arrhythmia and congestive heart failure, etc.); 5.Female patients who are either pregnant or lactating; 6.As known to the subjects and the researchers, the subjects may be unable to complete all the study visits or procedures required by the study protocol, including follow-up visits, and/or may be unable to comply with all the required study procedures; 7.Any other clinically significant medical history or current medical condition (other than those listed above), which, in the investigator's judgment, may pose a risk to the subject's safety or interfere with the study evaluation or completion of procedures;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CR/CRi rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Minimal residual disease negativity rate;Transplantation;Event-free survival;The negative rate of T315I mutation;Overall survival;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactMi Jianqing;Wang Jin
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed