RecruitingPhase 1Phase 2NCT07387926

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)

Open-label, Phase I/II Study to Evaluate Safety and Efficacy of Asciminib With Chemotherapy Followed by Asciminib Plus Blinatumomab in Pediatric, Adolescent, and Young Adults With Relapsed or Refractory BCR::ABL1-positive (Philadelphia Positive, Ph+) or BCR::ABL1-like (Ph-like) ALL


Sponsor

Novartis Pharmaceuticals

Enrollment

50 participants

Start Date

Jul 5, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 YearMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Asciminib Adult formulation, a drug called Asciminib Pediatric formulation, and others for people with acute lymphoblastic leukemia, leukemia, lymphoblastic, acute, philadelphia-positive, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 1 Year to 30 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAsciminib Adult formulation

oral, administered daily (twice daily for participants with known T315I mutation); Cycles 1, 2, 3

DRUGAsciminib Pediatric formulation

oral, administered daily (twice daily for participants with known T315I mutation); Cycles 1, 2, 3

DRUGDexamethasone

Fixed doses, oral (preferred) or intravenous (IV) twice daily; Cycle 1, Days 1 - 14; (Cycle 1 = 28 days)

DRUGVincristine

Fixed doses, IV, weekly; Cycle 1

DRUGBlinatumomab

Dosing based on bone marrow disease burden and weight. Continuous IV infusion; Cycles 2, 3

DRUGMethotrexate (intrathecal)

Intrathecal

DRUGCytarabine (intrathecal)

Intrathecal

DRUGHydrocortisone (intrathecal)

Intrathecal

DRUGPrednisolone (intrathecal)

Intrathecal


Locations(1)

Novartis Investigative Site

Ramat Gan, Israel

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NCT07387926


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