WHO ICTRP trial

Study to determine the dose and safety of asciminib in pediatric patients with…

JPRN-jRCT2031210591 · Japan Primary Registries Network (JPRN) · Recruiting

Key facts

Trial ID JPRN-jRCT2031210591
Public title Study to determine the dose and safety of asciminib in pediatric patients with chronic myeloid leukemia
Scientific title A multi-center, open-label study to determine the dose and safety of oral asciminib in pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP), previously treated with one or more tyrosine kinase inhibitors - ASC4Kids
Primary sponsor Yamauchi Kyosuke
Registry Japan Primary Registries Network (JPRN)
Recruitment status Recruiting
Study type Interventional
Phase 1-2
Countries France;Japan;Germany;Japan;Hungary;Japan;Italy;Japan;Greece;Japan;Nertherlands;Japan;Poland;Japan;Russia;Japan;Korea;Japan;Thailand;Japan;Turkey;Japan;China;Japan;US;Japan
Conditions Philadelphia chromosome positive chronic myeloid leukemia in chronic phase
Interventions Drug: Asciminib Pediatric formulation group Mini-tablets will be supplied as size 0 capsules containing 1 mg mini-tablets, taken orally: 10 mg (10x 1 mg tablets in capsule) BID 15 mg (15x 1 mg tablets in capsule) 20 mg (20x 1 mg tablets in…
Registration date Jan 2, 2022
Target size 3
Secondary IDs NCT04925479
Registry page jrct.niph.go.jp

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