Efficacy and Safety of TKI Combined With Chemotherapy and Sequential CAR-T Cells in ND Adult Patients With Ph+ ALL

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Jun 28, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for adults with Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), a type of blood cancer. The researchers want to see if combining a targeted therapy (TKI) with chemotherapy and a special kind of immune therapy called CAR-T cells can help patients who have just been diagnosed. The goal is to help these patients achieve complete remission (meaning no signs of cancer) while reducing the amount of chemotherapy they need, which can lessen side effects and improve their overall quality of life.

To participate in this trial, patients must be at least 18 years old and newly diagnosed with Ph+ ALL. They should have certain indicators in their blood that show they are eligible, and they need to be in good overall health to start treatment. If chosen for the study, participants can expect to receive a combination of treatments aimed at fighting their leukemia while being monitored closely for safety and effectiveness. This trial is currently recruiting participants and aims to provide new hope for those facing this challenging diagnosis.

Gender

ALL

Eligibility 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