Efficacy, Safety, and Pharmacokinetics of ThisCART19A Combined With Olverembatinib in Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia.
About this study
This is an Open, Prospective, Single-arm Study, which is designed to evaluate the efficacy, safety and pharmacokinetics of ThisCART19A Combined With Olverembatinib for the treatment of Newly Diagnosed Ph-positive lymphoblastic leukemia.
- Condition
- Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
- Tested
- ThisCART19A, Fludarabine, Cyclophosphamide, Olverembatinib
- Sponsor
- The First Affiliated Hospital of Soochow University
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 7
- Minimum age: 18 years
- Study condition: Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
- Male or non-pregnant, non-lactating female patients who are 18 years of age or older.
- Newly diagnosed Philadelphia chromosome-positive (Ph+) or BCR-ABL1-positive ALL, as defined by the 2016-WHO criteria. Participants should not be treated with any kind of TKIs or chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, and expected survival period ≥ 3 months.
- Organ function as indicated by the following laboratory indicators must be met:
- \. Alanine aminotransferase (ALT) ≤ 5×upper limit of normal (ULN), aspartate aminotransferase (AST) ≤ 5×ULN; 2. Total bilirubin\<2×ULN; 3. 24-hour calculated creatinine clearance\>30 mL/min; 4. SpO2≥92%; 5. Cardiac ejection fraction (EF)≥40%;
Exclusion 13
- Active hepatitis B virus (defined as serum HBV-DNA ≥ 2000 IU/mL), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or active syphilis infection prior to enrollment.
- (Subjects with HBV-DNA \< 2000 IU/mL can be enrolled, but should be administered antiviral drugs such as entecavir and tenofovir with relative clinical indicators monitored simultaneously during the treatment.) ;
- Uncontrolled active infection;
- Patients who are currently suffering from active autoimmune disease or a history of autoimmune disease potentially involving the CNS;
- Patients who have any history of heart or vascular disease, such as hypertension (systolic blood pressure(HBP) \> 140mmHg and/or diastolic blood pressure \> 90mmHg);
- Cardiac ultrasonography indicates that pulmonary artery systolic blood pressure is \>50 mmHg; or there are clinical symptoms related to pulmonary arterial hypertension;
- Patients who suffer from severe bleeding disorders unrelated to Ph+ ALL;
- Patients who have any other malignant tumors that require treatment;
- Patients who have severe hypertriglyceridemia (triglyceride ≥ 5.6mmol/L);
- Patients who are pregnant, planning to become pregnant or breastfeeding;
- Patients who underwent major surgery (except for minor surgery such as catheter placement or bone marrow biopsy) within 14 days before the first drug;
- Patients who may not be able to complete all study visits or procedures required by the study protocol, including follow-up visits, and/or fail to comply with all required study procedures;
- Patients who suffer from any condition or illness that, in the opinion of the Investigator, would compromise patient safety or interfere with the evaluation of the safety of the research drug.
Where
2 sites, 2 recruiting
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Suzhou, Jiangsu, China
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Suzhou, Jiangsu, China
Contact
-
Suning Chen, professor
+86-13814881746 chensuning@sina.com
Potential match only. Final eligibility is determined by the study team.