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)
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Białaczka limfoblastyczna typu Philadelphia-dodatnia lub ABL-podobna, także z mutacją T315I
- •Wiek od 1 roku do 30 lat
- •Aktywna białaczka w momencie przyjęcia do badania
- •Pierwsza leczba nieudana (białaczka nie ustąpiła) lub nawrót białaczki po poprzednim leczeniu
- •Prawidłowe funkcjonowanie wątroby (nisko podwyższone wartości badań)
- •Prawidłowe funkcjonowanie nerek
- •Dobre funkcjonowanie serca (sprawdzone badaniem echokardiograficznym)
✗ Disqualifies
- •Więcej niż 3 nawroty białaczki
- •Rozsianie się białaczki poza szpik kostny i mózg
- •Objawy białaczki w centralnym układzie nerwowym (zaburzenia widzenia, porażenie)
- •Poważne zaburzenia rytmu serca lub długi QT
Simplified criteria — AI translation
Trial details
- Minimum age
- 1 Year
- Maximum age
- 30 Years
- Last updated (source)
- September 11, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (3)
Novartis Investigative Site
Sydney, Australia
Novartis Investigative Site
Ramat Gan, Israel
Novartis Investigative Site
Taipei, Taiwan
Trial contact
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/21/2026.
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