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)

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07387926
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Acute Lymphoblastic Leukemia
  • Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
  • Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex
ALL
Age
1 Year - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Asciminib Adult formulation — DRUG
    oral, administered daily (twice daily for participants with known T315I mutation); Cycles 1, 2, 3
  • Asciminib Pediatric formulation — DRUG
    oral, administered daily (twice daily for participants with known T315I mutation); Cycles 1, 2, 3
  • Dexamethasone — DRUG
    Fixed doses, oral (preferred) or intravenous (IV) twice daily; Cycle 1, Days 1 - 14; (Cycle 1 = 28 days)
  • Vincristine — DRUG
    Fixed doses, IV, weekly; Cycle 1
  • Blinatumomab — DRUG
    Dosing based on bone marrow disease burden and weight. Continuous IV infusion; Cycles 2, 3
  • Methotrexate (intrathecal) — DRUG
    Intrathecal
  • Cytarabine (intrathecal) — DRUG
    Intrathecal
  • Hydrocortisone (intrathecal) — DRUG
    Intrathecal
  • Prednisolone (intrathecal) — DRUG
    Intrathecal

Study Details

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.

Key Dates

First listed
Feb 4, 2026
Start date
Jul 5, 2026
Status verified
Jul 2026
Primary completion
Sep 19, 2033
Completion
May 30, 2036

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    Asciminib Adult formulation group: escalating doses evaluated Asciminib Pediatric formulation group: dose is based on body weight; dose level being evaluated will be converted into a mg/kg daily dose. For known T315I mutation: Fixed asciminib dose twice daily or the pediatric formulation dose equivalent twice daily.

Primary Outcome Measure

Part 1 Dose Escalation: Incidence of Dose Limiting Toxicities (DLTs) occurring during cycle 1 (debulking induction) [ Time Frame: During Cycle 1 (Cycle 1 = 28 days) ]

Central Contacts

  • Novartis Pharmaceuticals
    1-888-669-6682
    [email protected]
  • Novartis Pharmaceuticals
    +41613241111

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