Clinical Trial 23477

• Overview

  Study Title:

  Phase 1 Study of Asciminib Maintenance Therapy Following Allogeneic Stem Cell Transplant or Chimeric Antigen Receptor T Cell Therapy (CAR T) to Prevent Relapse in Adults with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

  Summary:

  The purpose of the study is to see if a study drug called asciminib is safe and okay for people to take after they've had treatment for a type of blood cancer called Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ B-ALL). We're looking at two groups of adults: one group had an Allogeneic Stem Cell Transplant (alloHCT) cohort A, and the other group had chimeric antigen receptor T cell (CAR T) therapy, cohort B. We also want to figure out what the best dose of asciminib is to use moving forward in future studies.

  Objective:

  Primary objective: to evaluate the safety and tolerability of asciminib maintenance for adults with Ph+ B-ALL following alloHCT or CAR T cell therapy. The primary endpoint is to determine the incidence of dose-limiting toxicities (DLTs) at each asciminib dose level to identify the recommended phase 2 dose (RP2D). Secondary: Assess overall survival, relapse free survival (RFS), non-relapse mortality (NRM) and cumulative incidence of relapse. Assess measurable residual disease negativity rate. Estimate grade II-IV acute and moderate/extensive chronic graft vs. host disease (cohort A only) in patients receiving asciminib maintenance therapy following alloHCT.

• Treatments

  Therapies:

  Tyrosine Kinase Inhibitor

  Medications:

  Asciminib ()

• Inclusion Criteria

  Inclusion Criteria:
  • Age ≥18 years
  • Diagnosis of Ph+ B-ALL with detectable Philadelphia chromosome abnormalities
  • Morphologic remission (> ECOG performance status 0-2
  • Adequate organ function

• Exclusion Criteria

  Exclusion Criteria:
  • Active relapsed disease (>5% blasts)
  • Grade II-IV acute GVHD requiring systemic steroids
  • Significant organ dysfunction or uncontrolled infection
  • Pregnancy or breastfeeding
  • Prior investigational CAR T product

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