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NOT YET 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

2026-03-26

Completion Date

2035-12-12

Last Updated

2026-02-04

Healthy Volunteers

No

Interventions

DRUG

Asciminib Adult formulation

oral, administered daily; Cycles 1, 2, 3

DRUG

Asciminib Pediatric formulation

oral, administered daily; 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