Efficacy, Safety, and Pharmacokinetics of ThisCART19A Combined With Olverembatinib in Patients Wi… (NCT07074496) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Efficacy, Safety, and Pharmacokinetics of ThisCART19A Combined With Olverembatinib in Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia.
China20 participantsStarted 2024-01-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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:
Exclusion criteria
✕. 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;
✕
What they're measuring
1
Number of Participants with Complete Molecular Remission
Timeframe: 4 weeks
2
Incidence of adverse events (AEs)
Timeframe: 2 years
Trial details
NCT IDNCT07074496
SponsorThe First Affiliated Hospital of Soochow University