CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 34 target
Drug / intervention
Asciminib Pediatric formulation group +1 moredrug
Likely dose
Asciminib Pediatric formulation group 1 mgfrom record
Key inclusion· 7
  • ✓Philadelphia positive chronic myeloid leukemia in chronic phase
  • ✓Age ≥1 and <18 years (pediatric) or ≥14 and <18 years with body weight ≥40 kg (adult formulation)
  • ✓Prior treatment with minimum of one TKI
  • ✓Failure or intolerance to most recent TKI therapy
Key exclusion· 11
  • ✕Known T315I mutation prior to study entry
  • ✕BCR-ABL mutation with known resistance to study treatment prior to study entry
  • ✕Known second chronic phase of CML after previous progression to AP/BC
  • ✕Previous treatment with hematopoietic stem-cell transplantation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04925479
NCT04925479Phase 1RecruitingOn Track
Long Recruiting
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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

Novartis Pharmaceuticals·interventional·Posted Jun 14, 2021·Updated Jun 30, 2026

In Brief

A Phase 1 clinical trial evaluating Asciminib Pediatric formulation group and Asciminib Adult formulation group for Myeloid Leukemia, Philadelphia Positive. Currently recruiting, targeting 34 participants across 39 sites in 14 countries.

Detailed Summary

The aim of this study is to support development of asciminib in the pediatric population (1 to \<18 years) previously treated with one or more TKIs. Full extrapolation of the efficacy of asciminib from adult to pediatric patients will be conducted. Full extrapolation is based on the concept that CML in the pediatric population has the same pathogenesis, similar clinical characteristics and progression pattern as in adults.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyeloid Leukemia, Philadelphia Positive
CountriesChina, France, Germany, Greece, Hungary, Italy, Japan, Netherlands, Poland, Russia, South Korea, Thailand, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 1Recruiting
20222023202420252026202720282029203020312032
First PostedJun 14, 2021
Enrollment StartDec 27, 2021
Primary CompletionSep 21, 2027
Study CompletionNov 1, 2031
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 5.0 years agoPrimary completion in 1.2 years

Arms & Interventions

Asciminibexperimental

This arm consists of 2 groups: * The pediatric formulation group where the dose is based on body weight (1.3mg/kg BID or 2.6 mg/kg QD) * The adult formulation group where participants will receive a flat dose of 40mg BID

Drug: Asciminib Pediatric formulation groupDrug: Asciminib Adult formulation group

Interventions

Asciminib Pediatric formulation groupdrug

Asciminib Pediatric formulation group: 1 mg film-coated granules in a size 0 capsule will be supplied, taken orally (capsules are a container for the granules and are not ingested): 10 mg (10x 1 mg film-coated granules in capsule) 15 mg (15x 1 mg film-coated granules in capsule) 30 mg (30x 1 mg film-coated granules in capsule)

Asciminib Adult formulation groupdrug

Asciminib Adult formulation group: 40 mg tablets BID, taken orally. 20 mg tablets BID, taken orally.