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Study identifier: NCT07387926 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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)

Condition: Acute Lymphoblastic Leukemia · Leukemia, Lymphoblastic, Acute, Philadelphia-Positive · Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia  ·  Sponsor: Novartis Pharmaceuticals

PhasePhase 1/Phase 2
Planned participants50
Who can joinAll sexes, 1 Year to 30 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Novartis Pharmaceuticals  ·  1-888-669-6682  ·  novartis.email@novartis.com

Novartis Pharmaceuticals  ·  +41613241111

Always discuss trial participation with your own doctor first.

Locations (1)

Novartis Investigative SiteRamat Gan, IsraelRecruiting

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Source record: clinicaltrials.gov/study/NCT07387926