Efficacy and Safety of Chemotherapy Combined With CAR-T Cells in Newly Diagnosed Adult Patients With Ph- B-ALL

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

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for adults with Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia (Ph- B-ALL), a type of blood cancer. The trial is exploring the use of CAR-T cell therapy, which is a type of immunotherapy that helps the body’s own immune system fight cancer. The goal is to combine this therapy with chemotherapy to help patients achieve complete remission, which means no signs of cancer, while also reducing the amount of chemotherapy needed and its side effects. Researchers believe this could improve patients' survival and quality of life.

To participate in this trial, individuals must be 18 years or older and have been diagnosed with Ph- B-ALL. They should show specific features in their blood cells that indicate they are suitable candidates for the treatment. Participants can expect to undergo a course of chemotherapy followed by CAR-T cell therapy, and they will be monitored closely for their health and response to the treatment. It’s important to know that certain conditions, such as active infections or serious heart problems, may prevent someone from joining the study. If you're considering participation, a healthcare provider can provide more detailed information about the eligibility criteria and the trial process.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. De novo and primary Ph/BCR-ABL1 negative acute lymphoblastic leukemia diagnosed by the bone marrow cytomorphology, immunophenotyping, cytogenetics and molecular biology according to WHO classification
• • 2. Male or female patients aged 18 years or older
• • 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. Burkitt lymphoma/leukemia
• • 2. Acute Leukemia of Ambiguous Lineage
• • 3. Clinical manifestations of active CNS or extramedullary involvement with ALL
• • 4. Female patients who are pregnant or breast feeding
• • 5. Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment
• • 6. Known HIV seropositivity
• • 7. Clinically significant ventricular arrhythmias, unexplained syncope (not vasovagal) or sinus block, history of chronic bradycardia with a high degree of atrioventricular (AV) conduction block (unless a permanent pacemaker is implanted)
• • 8. Any serious psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment
• • 9. Other conditions assessed by the investigators to be inappropriate for this study