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RECRUITING
NCT07387926
PHASE1/PHASE2

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

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

1 Year - 30 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-07-05

Completion Date

2036-05-30

Last Updated

2026-09-11

Healthy Volunteers

No

Interventions

DRUG

Asciminib Adult formulation

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

DRUG

Asciminib Pediatric formulation

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

DRUG

Dexamethasone

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

DRUG

Vincristine

Fixed doses, IV, weekly; Cycle 1

DRUG

Blinatumomab

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

DRUG

Methotrexate (intrathecal)

Intrathecal

DRUG

Cytarabine (intrathecal)

Intrathecal

DRUG

Hydrocortisone (intrathecal)

Intrathecal

DRUG

Prednisolone (intrathecal)

Intrathecal

Locations (3)

Novartis Investigative Site

Sydney, New South Wales, Australia

Novartis Investigative Site

Ramat Gan, Israel

Novartis Investigative Site

Taipei, Taiwan