Combining CAR-T therapy with chemotherapy for newly diagnosed Ph+ acute lymphoblastic leukemia

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 study evaluates a treatment regimen that combines CAR-T cell therapy with chemotherapy and targeted agents for adults with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). The approach aims to achieve complete remission using overembatinib and venetoclax alongside reduced-intensity chemotherapy, followed by CAR-T cell infusion as a consolidation method. The goal is to reduce chemotherapy cycles and associated toxicities, shorten hospitalization, and ultimately enhance survival and quality of life for patients. The CAR-T cells used are second-generation CD19 CAR-T cells designed to target leukemia cells effectively.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female patients aged 18 years or older
2. Newly diagnosed Philadelphia chromosome positive(either t(9;22) and/or BCR-ABL positive and/ or FISH positive) acute lymphoblastic leukemia
3. CD19 expression on blasts
4. Expected survival time greater than 3 months
5. Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal（ULN）; serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤5 x ULN if leukemic involvement of the liver is present; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; normal electrolytes: Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN; Cardiac color Doppler ultrasound ejection fraction ≥ 45%
6. Subject has provided written informed consent prior to any screening procedure

Exclusion Criteria:

1. Lymphoid blast crisis of chronic myelocytic leukemia (CML)
2. Previous or ongoing systemic anti-ALL therapy (including but not restricted to TKI and/or radiotherapy, except for appropriate pre-treatment)
3. Patients with a history of myocardial infarction within 12 months or clinically significant cardiac disorders disease (e.g., unstable angina, congestive heart failure, uncontrollable hypertension, uncontrollable arrhythmia, etc.)
4. Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment
5. Known HIV seropositivity
6. History of acute pancreatitis within 1 year of study screening or history of chronic pancreatitis
7. Uncontrolled hypertriglyceridemia (triglycerides \>450 mg/dL)
8. Another malignancy diagnosed and treated within 5 years prior to diagnosis or previously diagnosed with another malignancy with evidence of residual disease. Patients with non-melanoma skin cancer or any type of carcinoma in situ that has been completely excised should not be excluded
9. Female patients who are pregnant or breast feeding
10. Clinical manifestations of active CNS or extramedullary involvement with ALL
11. Poorly controlled diabetes, defined as glycosylated hemoglobin (HbA1c) values of \>7.5%. Patients with preexisting, well-controlled diabetes are not excluded
12. Any serious psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment
13. Other conditions assessed by the investigators to be inappropriate for this study

Where it's running

• Institute of Hematology & Blood Diseases Hospital
  Tianjin, China Recruiting

Study contacts

• Principal investigator: Jianxiang Wang, Dr — Institute of Hematology & Blood Diseases Hospital, China
• Study coordinator: Jianxiang Wang, Dr
• Email: wangjx@ihcams.ac.cn
• Phone: 86-22-23608451

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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.