RecruitingPhase 1/2

Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia

United States34 participantsStarted 2021-12-27

Plain-language 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.

Who can participate

Age range1 Year – 17 Years

SexALL

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Inclusion criteria

✓. \< 15% blasts in peripheral blood and bone marrow
✓. \< 30% combined blasts plus promyelocytes in peripheral blood and bone marrow
✓. \< 20% basophils in the peripheral blood
✓. Neutrophils ≥ 1.5 x 10\^9/L (or WBC ≥ 3 x 10\^9/L if neutrophils are not available) and platelet count ≥ 100 x 10\^9/L
✓. No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly

What they're measuring

Primary Pharmacokinetic (PK) parameter: AUClast

Timeframe: 52 weeks

Primary PK parameter: AUCtau

Timeframe: 52 weeks

Secondary PK parameter: Cmax

Timeframe: 52 weeks

Secondary PK parameter: Tmax

Timeframe: 52 weeks

Secondary PK parameter: Ctrough

Timeframe: 52 weeks

Trial details

NCT IDNCT04925479

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-16

Contact for this trial

Novartis Pharmaceuticals

1-888-669-6682 novartis.email@novartis.com

View on ClinicalTrials.gov More Myeloid Leukemia, Philadelphia Positive trials