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Date of registration	June. 26, 2026
Last modified on	June. 26, 2026
Trial ID	jRCT2031260265

Scientific Title	Study to Evaluate the Safety and Efficacy of Asciminib in Pediatric Patients With Ph+ CML-CP (CABL001I12202)
Public Title	Study to Evaluate the Safety and Efficacy of Asciminib in Pediatric Patients With Ph+ CML-CP (CABL001I12202)

Contact for Scientific Queries	Name	Yamauchi Kyosuke
	Affiliation	Novartis Pharma. K.K.
	Address	Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan
	Telephone	+81-120-003-293
	E-mail	rinshoshiken.toroku2@novartis.com
Contact for Public Queries	Name	Yamauchi Kyosuke
	Affiliation	Novartis Pharma. K.K.
	Address	Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan
	Telephone	+81-120-003-293
	E-mail	rinshoshiken.toroku2@novartis.com

Recruitment status	Pending

Anticipated date of first enrollment		June. 30, 2026
Target sample size		3
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- Signed informed consent must be obtained prior to participation in the study. - Male or female participants 1 and < 18 years of age at study enrollment - Diagnosis of CML-CP (Apperley et al 2025) with cytogenetic confirmation of Philadelphia positive (Ph+) chromosome - For participants with CML-CP newly diagnosed within 3 months of screening OR 5 For participants with CML - CP with high risk of developing resistance or intolerance to previous TKI: -Unfavourable response to TKI is defined following the Apperley et al 2025 guidelines as: At three months after the initiation of therapy: BCR::ABL1 ratio > 10% IS (if confirmed within 1-3 months) At six months after the initiation of therapy: BCR::ABL1 ratio > 10% IS At twelve months after initiation of therapy: BCR::ABL1 ratio > 1% IS At any time loss of previous response At any time emergent resistant BCR::ABL1 mutations or high-risk ACA from prior TKI treatment as per local test results -Intolerance to TKI is defined as: Non-hematologic intolerance: participants with grade 3 or 4 toxicity while on therapy (in which case the patient is eligible whether or not there was a dose reduction); or with persistent grade 2 toxicity unresponsive to optimal management including dose adjustments (unless dose reduction is not considered in the best interest of the patient if response is already suboptimal) Hematologic intolerance: participants with grade 3 or 4 toxicity (absolute neutrophil count [ANC] or platelets) while on therapy that is recurrent after dose reduction to the lowest doses of the TKI - Evidence of typical BCR::ABL1 transcript [e14a2 and/or e13a2] at the time of screening which are amenable to standardized RQ-PCR quantification. - Performance status: Karnofsky >= 50% for participants >= 16 years of age, and Lansky >= 50 for participants < 16 years of age at the time of screening.
	Exclusion Criteria	- Known second chronic phase (CP) of CML after previous progression to Accelerated Phase (AP)/Blast Phase (BP). - Previous treatment with a hematopoietic stem-cell transplantation. - Patient planned to undergo allogeneic hematopoietic stem cell transplantation - Known presence of a BCR::ABL1 mutation with known resistance to study treatment in accordance with the most recent public version of international CML clinical guidelines (e.g. NCCN CML treatment guidelines v 1.2026 and Apperley et al 2025) any time prior to study entry
	Age Minimum	1age old over
	Age Maximum	18age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Pediatric Patients With Ph+ CML-CP
Intervention(s)		Asciminib single agent
Primary Outcome(s)		MMR at Week 48

Primary Sponsor	Novartis Pharma. K.K.

Secondary Sponsor

Name of Certified Review Board	Pediatric Central Institutional Review Board
Address	2-10-1 Okura, Setagaya-ku, Tokyo, Tokyo
Approval Status	Approval
Date of approval	April. 01, 2026

Plan to share IPD	Yes
Plan description	Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

Plan to share IPD

Yes

Plan description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

Secondary ID(s)	NCT07354074
Issuing Authority	Clinical Trials.gov

Countries of Recruitment（Except Japan）	Australia/Brazil/Canada/China/France/Germany/Greece/Hungary/Italy/Korea/Mexico/Netherlands/Poland/Singapore/Spain/Thailand/Turkey/United States/Vietnam