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Taking people in SingaporePhase 2

Tests asciminib in children with chronic myeloid leukemia

Tests asciminib in children aged 1 to under 18 with Ph+ chronic myeloid leukemia.

Key facts

Who runs it
Novartis Pharmaceuticals
Where
Singapore, SingaporeSee the siteAlso in 16 other countries, 35 sites
Registry title
Study to Determine the Efficacy and Safety of Asciminib in Pediatric Patients With Ph+ CML-CP
Status
Recruiting
Phase
Phase 2
People taking part
50 people, planned
Started
28 Apr 2026
Expected to end
23 Feb 2033
Type of study
Interventional
Treatments tested
  • Asciminib single agent
Record updated
10 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase. They may be newly diagnosed or may have been treated before.

Age
From 1 year to under 18 years old.
Sex
Boys and girls can both join.
Disease stage
Chronic phase CML with the Philadelphia chromosome confirmed by a lab test. Either newly diagnosed within 3 months of screening, or previously treated with a TKI (a targeted cancer drug) with a poor response, high risk of resistance, or side effects that were not tolerated.
Earlier treatment
New patients need no earlier treatment. Others may have had a TKI with a poor response or bad side effects. No earlier stem-cell transplant.
Biomarker or test result
Typical BCR::ABL1 transcript (e14a2 and/or e13a2) that can be measured by a standard test (RQ-PCR).

Main reasons for not taking part

  • A second chronic phase after the disease had moved to accelerated or blast phase
  • A previous stem-cell transplant
  • A planned donor stem-cell transplant
  • A known BCR::ABL1 mutation with known resistance to the study treatment

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • Participants eligible for inclusion in this study must meet all of the following 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

Who cannot take part

  • 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; Other inclusion/exclusion criteria may apply

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 1 and 18 years old?
  • What type of cancer has the patient been diagnosed with?
  • Has the patient had a stem cell transplant (a transplant of blood-forming cells from a donor or from their own body)?

Where in Singapore

Also in 16 other countries, 35 sites

  • SingaporeHospital not named in the registryContact: Novartis PharmaceuticalsTaking people

About the trial

What the trial wants to find out

The aim of this study is to support development of asciminib in the pediatric population (1 to < 18 years) with Ph+ CML-CP. The study will evaluate the efficacy and safety of asciminib in pediatric formulation (weigh-based dose, fed state) or adult formulation (fasted) in newly diagnosed and resistant or intolerant Ph+ CML-CP with or without T315I mutation.

The group in the trial

  • Single arm studyTreatment being tested

    This study will enroll pediatric patients (≥ 1 and \< 18 years of age) with newly diagnosed or previously treated with Philadelphia positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP) with or without known T315I mutation

    Treatment: Asciminib single agent

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase II, Multicenter, Open-label, Single Arm Study to Evaluate the Safety and Efficacy of Asciminib in Pediatric Participants Newly Diagnosed or Previously Treated With Philadelphia Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP) With or Without Known T315I Mutation
Plain-language title
Tests asciminib in children with chronic myeloid leukemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Fit questions
Built from NCT07354074, who can take part
Record updated
10 November 2026