Not Yet RecruitingPhase 1/2

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)

50 participantsStarted 2026-03-26

Plain-language summary

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.

Who can participate

Age range1 Year – 30 Years

SexALL

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Inclusion criteria

✓. Primary refractory disease (\>0.01% ALL blasts present at the end of consolidation) OR
✓. Relapsed ALL with evidence of involvement of BM with ALL (MFC or IG/TCR PCR \>0.01%) after at least one line of therapy
✓. ALT ≤ 5x upper limit of normal (ULN) for age
✓. Total bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x ULN) for age, except for participants with Gilbert's syndrome who may only be included if total bilirubin ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN
✓. Estimated glomerular filtration rate (eGFR) using the Cockcroft-Gault formula in participants ≥ 18 years, OR radioisotope GFR ≥50 mL/min/1.73 m\^2, OR creatinine based on age and sex for participants \< 18 years old

What they're measuring

Part 1 Dose Escalation: To determine the Recommended Phase II Dose (RP2D) of asciminib when administered with low intensity chemotherapy

Timeframe: During Cycle 1 (Cycle 1 = 28 days)

Part 2 Dose Expansion: Assess the rate of complete remission (CR) at RP2D

Timeframe: End of Cycle 1 (Cycle 1 = 28 days)

Trial details

NCT IDNCT07387926

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2033-01-10

Contact for this trial

Novartis Pharmaceuticals

1-888-669-6682 novartis.email@novartis.com

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