Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+) or ABL-class Ph-like Acute Lymphoblastic Leukemia (ALL)

Multi-center, open-label, single arm study of asciminib in participants aged ≥1 year to ≤30 years old with r/r Ph+ or ABL-class Ph-like ALL. This study will have 2 parts: Part 1 dose escalation and Part 2 dose expansion. Part 1 dose escalation will enroll participants aged ≥1 year to ≤30 years to determine the recommended phase 2 dose (RP2D) of asciminib when administered with low intensity chemotherapy. Part 2 dose expansion will enroll participants aged ≥1 year to ≤30 years to evaluate safety, tolerability, and efficacy of asciminib at the RP2D with the treatment regimen.

Trial Details

NCT ID
NCT07387926
Phase
PHASE1 / PHASE2
Sponsor
Novartis Pharmaceuticals
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Asciminib Adult formulation
  • Asciminib Pediatric formulation
  • Dexamethasone
  • Vincristine
  • Blinatumomab
  • Methotrexate (intrathecal)
Locations (sample)
  • Ramat Gan, Israel|32.08227,34.81065

Key Eligibility Criteria

  • Evidence of Ph+ ALL or ABL1 or ABL2 fusion Ph-like ALL, inclusive of participants with ABL1 T315I mutation
  • Participants with CNS1, CNS2, CNS3a, or CNS3b at screening
  • Active B-Cell ALL at screening defined by MFC or IG/TCR PCR of ALL blasts \>0.01% in participants with either:
  • Primary refractory disease (\>0.01% ALL blasts present at the end of consolidation) OR

For full eligibility, visit ClinicalTrials.gov.

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