ThisCART19A plus Olverembatinib for newly diagnosed Ph+ ALL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase, single-arm trial evaluates the safety, efficacy, and pharmacokinetics of ThisCART19A combined with Olverembatinib in adults with newly diagnosed Ph+ ALL. Induction uses VP chemotherapy to reduce leukocyte counts, followed by a fludarabine/cyclophosphamide regimen and ThisCART19A infusion. Olverembatinib is used as maintenance therapy after achieving hematologic remission, with potential additional ThisCART19A infusions based on MRD status; a consolidation infusion may occur for those in complete molecular remission at 6 months. CNS involvement is monitored with lumbar puncture procedures, and patients are followed for event-free and overall survival for up to 2 years.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or non-pregnant, non-lactating female patients who are 18 years of age or older.
2. 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.
3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, and expected survival period ≥ 3 months.
4. Organ function as indicated by the following laboratory indicators must be met:

1\. 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 Criteria:

1. 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.) ;
2. Uncontrolled active infection;
3. Patients who are currently suffering from active autoimmune disease or a history of autoimmune disease potentially involving the CNS;
4. Patients who have any history of heart or vascular disease, such as hypertension (systolic blood pressure(HBP) \> 140mmHg and/or diastolic blood pressure \> 90mmHg);
5. Cardiac ultrasonography indicates that pulmonary artery systolic blood pressure is \>50 mmHg; or there are clinical symptoms related to pulmonary arterial hypertension;
6. Patients who suffer from severe bleeding disorders unrelated to Ph+ ALL;
7. Patients who have any other malignant tumors that require treatment;
8. Patients who have severe hypertriglyceridemia (triglyceride ≥ 5.6mmol/L);
9. Patients who are pregnant, planning to become pregnant or breastfeeding;
10. Patients who underwent major surgery (except for minor surgery such as catheter placement or bone marrow biopsy) within 14 days before the first drug;
11. 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;
12. 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 it's running

• The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
  Suzhou, Jiangsu, China Recruiting
• The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Suning Chen, professor
• Email: chensuning@sina.com
• Phone: +86-13814881746

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Combining Venetoclax, Olverembatinib, and Prednisone for treating Ph+ B-ALL

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.