Combining CAR-T therapy with chemotherapy for newly diagnosed Ph+ acute lymphoblastic leukemia
Efficacy and Safety of Molecular Targeted Therapy Combined With Chemotherapy and Sequential CAR-T Cells in Newly Diagnosed Adult Patients With Philadelphia Chromosome-Positive B-cell Acute Lymphoblastic Leukemia
This study is testing a new treatment that combines CAR-T therapy with chemotherapy to see if it can help adults with newly diagnosed Ph+ acute lymphoblastic leukemia feel better and live longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Drugs / interventions | blinatumomab, inotuzumab, overembatinib, CAR-T, chemotherapy, immunotherapy |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT06481228 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia.
Not a fit: Patients with lymphoid blast crisis of chronic myelocytic leukemia or those with previous systemic therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with Ph+ ALL.
How similar studies have performed: Other studies have shown promising results with CAR-T cell therapies in relapsed/refractory B-ALL, suggesting potential success in this novel frontline approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Tianjin
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.