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Tests treatment safety and results for Chronic Myelogenous Leukemia
Official title Study to Determine the Efficacy and Safety of Asciminib in Pediatric Patients With Ph+ CML-CP
ClinicalTrials.gov ID: NCT07354074
What this study is testing
What is Asciminib single agent?
Asciminib single agent is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic myelogenous leukemia.
Also referred to as ABL001.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 18
You may be able to join if
- Key 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...
You likely can't join if
- 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...
See the full eligibility criteria
- Key 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...
- 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 6\. Evidence of...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- New Brunswick, New Jersey, United States
- New York, New York, United States
- Brisbane, Queensland, Australia
- North Adelaide, South Australia, Australia
- Montreal, Quebec, Canada
- Zhengzhou, Henan, China
- Tianjin, China
- Marseille, France
- Paris, France
- Strasbourg, France
- Yokohama, Kanagawa, Japan
- Saitama, Japan
- Utrecht, Netherlands
- Seoul, South Korea
- Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Brunswick, New Jersey, United States; New York, New York, United States; Brisbane, Queensland, Australia; North Adelaide, South Australia, Australia; Montreal, Quebec, Canada; Zhengzhou, Henan, China and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.