Efficacy, Safety, and Pharmacokinetics of ThisCART19A Combined With Olverembatinib in Patients Wi… (NCT07074496) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.) ;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Complete Molecular Remission
Timeframe: 3 months
2
Incidence of adverse events (AEs)
Timeframe: 2 years
Trial details
NCT IDNCT07074496
SponsorThe First Affiliated Hospital of Soochow University
. 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);