Axicabtagene ciloleucel as first-line therapy in high-risk large B-cell lymphoma: the phase 2 ZUMA-12 trial - Nature Medicine

; serum alanine aminotransferase and aspartate aminotransferase ≤2.5 upper limit of normal; total bilirubin ≤1.5 mg dl, except in patients with Gilbert’s syndrome; cardiac ejection fraction ≥50%); no evidence of pericardial effusion as determined by echocardiogram, and no clinically notable electrocardiogram findings; no clinically notable pleural effusion; and baseline oxygen saturation >92% on room air.

Patients were excluded from the trial if any of the following applied: a history of malignancy other than nonmelanoma skin cancer or carcinoma in situ, unless disease-free for at least 3 years; a history of Richter’s transformation of chronic lymphocytic leukemia or PMBCL; a history of autologous or allogeneic stem cell transplantation; previous CD19-targeted therapy previous CAR T-cell therapy or other genetically modified T-cell therapy; history of severe, immediate hypersensitivity reaction...

All patients enrolled in the study provided written informed consent, and the study was conducted in accordance with applicable International Conference on Harmonisation Good Clinical Practice Guidelines, the principles of the Declaration of Helsinki and any applicable local laws and regulations. The protocol was approved by the institutional review board or independent ethics committee at each study site –Service Hematologic Seniors) and was provided to the key sponsor contact.

Within approximately 5 days of eligibility, laboratory monitoring began and then continued on days −5, −4 and −3; day 0; and days 1–7 after infusion. Post-treatment follow-up monitoring occurred at weeks 2 and 4, months 2 and 3 and then every 3 months thereafter until month 24. Disease response assessment was performed locally by PET–CT at week 4, month 3 and then every 3 months thereafter until month 24 or until disease progression, whichever occurred first.

All adverse events observed by the investigator or reported by the patient that occurred from enrollment up to 3 months after treatment with axi-cel infusion were reported. After 3 months, targeted adverse events were monitored and reported for 24 months after treatment with axi-cel or until disease progression, whichever occurred first. For patients who were enrolled but did not receive axi-cel, the adverse event-reporting period ended 30 days after the final study-specific procedure .

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