A multi-center, open-label, phase I/II study to evaluate the safety and efficacy of asciminib with chemotherapy followed by blinatumomab in pediatric, adolescent, and young adult patients with relapsed or refractory BCR::ABL1-positive (Ph+) or ABL-class Ph-like Acute Lymphoblastic Leukemia (ALL)

Ph+) or BCR::ABL1-like (Ph-like) acute lymphoblastic leukemia (ALL), relapsed or refractory BCR::ABL1-positive (Philadelphia positive

Part 1 Dose Escalation: Incidence of DLTs occurring during cycle 1 (debulking induction), Part 1 Dose Escalation: incidence of severity of AEs and laboratory safety findings, Part 2 Dose Expansion: Proportion of CR evaluable participants who achieve CR treated at the RP2D at the end of cycle 1 (debulking induction)

• Proportion of participants who had a CR at the end of cycle 2 and cycle 3, • Proportion of participants who had CR and/or CRi at and by the end of: cycle 1, cycle 2, and cycle 3, • Next generation sequencing MRD negative rate at and by the end of: end of cycle 1, cycle 2, and cycle 3., • MFC MRD negative CR/CRi rate at and by the end of: cycle 1, cycle 2, and cycle 3., • Disease Free Survival, • Overall survival, Type, frequency, severity of treatment emergent adverse events, changes in laboratory parameters, ECG, and other safety data., PK parameters of asciminib at steady state: AUClast, Cmax, Tmax, Ctrough over time (sparse PK sampling)

No related papers found yet.