Study of the safety and efficacy of asciminib in pediatric and young adult participants with r/r Ph+ or ABL-class Ph-like ALL

Prior treatment

• History of hematopoietic stem cell transplant within the prior 12 weeks
• Presence of active acute or chronic graft-versus-host disease (GVHD). Hematopoietic stem cell transplant recipients receiving any agent to treat or prevent GVHD within 4 weeks are not eligible for this trial.

Other illness

• Extramedullary disease (non-CNS and/ or isolated CNS disease) at screening
• Participants with CNS3c at screening (Clinical signs of CNS leukemia (such as facial nerve palsy, brain/eye involvement or hypothalamic syndrome).

Other

• Participants with >3 relapses of ALL at screening.

• Male or female participants ≥1 year to ≤30 years of age at screening
• Participants with documented history of either Ph+ ALL or ABL-class Ph-like ALL with ABL1 or ABL2 rearrangements. Genetic testing will be performed locally and eligible alterations confirmed by treating investigators; central confirmation will not be performed as part of the study. (Of note, participants with known T315I mutations are eligible for inclusion in a separate cohort).
• Active B-Cell ALL at screening defined by MFC or IG/TCR PCR of ALL blasts >0.01% in participants with either: a. Primary refractory disease (>0.01% ALL blasts present at the end of induction and 1 consolidation cycle) OR b. Relapsed ALL with evidence of involvement of BM with ALL (MFC or IG/TCR PCR>0.01%) after at least one line of therapy
• Participants with CNS1, CNS2, CNS3a or CNS3b at screening.
• Documented history of CD19 expressing B-cell ALL (in peripheral blood or bone marrow by flow cytometry) a. For participants who received anti-CD19 targeted therapy (e.g CD19 CAR T cells or blinatumomab), CD19 expressing B-cell ALL must be documented after anti-CD19 therapy completion prior to cycle 1 day 1.