1/2상모집 예정
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)
연구 개요
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.
- 스폰서
- 리드: 노바티스
- 적응증
- Acute Lymphoblastic Leukemia, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive, Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
- 중재
- Asciminib Adult formulation, Asciminib Pediatric formulation, Dexamethasone, Vincristine, Blinatumomab, Methotrexate (intrathecal), Cytarabine (intrathecal), Hydrocortisone (intrathecal), Prednisolone (intrathecal)
- 목표 등록
- 50명
- 시작일
- 2026-07-30
- 완료(예정)
- 2036-06-18
BioPulse가 제공하는 정보는 공개된 자료를 요약·정리한 것으로, 투자 조언이나 의료 조언이 아닙니다. 임상 데이터·규제 일정·공시 내용은 반드시 원문을 직접 확인하시기 바랍니다.