Tisagenlecleucel vs Blinatumomab or Inotuzumab for Patients With Relapsed/Refractory B-cell Precursor Acute Lymphoblastic Leukemia

Event Free Survival (EFS)

EFS, assessed up to 48 months, is defined as the date from randomization to the earliest of (a) date of death due to any cause, (b) relapse after CR/CRi, or (c) treatment failure, which is defined as failure to achieve remission within 12 weeks of randomization.

Time frame: 4 years

Percentage of patients who achieved MRD negative CR/CRi

Percentage of patients who achieved MRD negative CR/CRi at month 3 post randomization

Time frame: 4 years

Overall response rate

ORR is defined as the proportion of subjects with best overall response (BOR) of CR or CRi, where the BOR is defined as the best response recorded from randomization until the start of new anticancer therapy or the data cut-off date, whichever is earlier

Time frame: 4 years

Duration of response (DOR)

DOR is defined as the duration from the date when the response criteria of CR/CRi is first met to the date of relapse or death due to underlying cancer.

Time frame: 4 years

Probability of patients who achieved CR/CRi at month 12

Probability of achieving CR/CRi based on all response assessments between randomization and month 12. This outcome measure will be based on all randomized patients and the assessment will be up to 48 months (from randomization of the first patient until 12 months after the randomization of the last patient).

Time frame: 4 years