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Clinical Trials/jRCT2031260265
jRCT2031260265Not yet recruitingNot Applicable

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

Not provided0 sites3 target enrollmentStarted: TBD
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
3
Study OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Single Arm Study

Eligibility Criteria

Ages
1age old over to 18age old not (—)
Sex
All

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

Investigators

Sponsor
Not provided

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