A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)
Categories (click each to see list of all clinical trials associated with that category): Pediatric (PEDONC)
Current Status: Open
Phase: II (Cancer Control)
Principal Investigator: Beck, Jill
Contact Information:
Angie Boettner
aboettner@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT04546399?term=NCT04546399&rank=1
Summary
Primary Outcome Measures :
Minimal residual disease (MRD) negative second remission (Rem-2) rate with blinatumomab vs with blinatumomab + nivolumab (Group 1) [ Time Frame: Up to 2 cycles of therapy (each cycle = 36 days) ]
MRD negative Rem-2 be defined as Rem-2 (i.e., achievement of MRD < 1% blasts by flow cytometry and resolution of extramedullary disease (for CNS disease, requires CNS 1) ) and bone marrow with MRD < 0.01% by flow cytometry. MRD negative Rem-2 rate between Arm A vs Arm B will be compared using a one-sided Z test of proportions with Type I error of 0.10. Interim analysis will be conducted to monitor for futility. The futility boundary will be based on testing the alternative hypothesis at the 0.067 level.
Event-free survival post-induction (Group 3) [ Time Frame: From date of randomization to date of relapse, disease progression, second malignancy (SMN) or death due to any cause, assessed up to 10 years after completion of enrollment. ]
Comparison of EFS post induction between Arm E versus Arm F will be based on a one-sided two-sample logrank test with Type I error of 0.10, to be conducted 3 years after completion of enrollment of Group 3. Interim analysis will be conducted to monitor for futility. The futility boundary will be based on testing the alternative hypothesis at the 0.067 level.