Actively Recruiting
Open-label Study of Asciminib for CML-CP or CML-AP Patients With T315I Mutation Who Are Resistant, Intolerant or Ineligible to Ponatinib.
Led by Novartis Pharmaceuticals · Updated on 2026-04-21
20
Participants Needed
6
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this Phase II study is to assess the potential of asciminib in managing CML-CP or CML-AP in patient carrying the T315I mutation. The presence of this mutation introduces treatment difficulties due to the limited available options. The study seeks to collect additional data on the effectiveness and safety of asciminib for these patients. By determining the drug's capacity to manage the disease and enhance patients outcomes, the study is designed to fill the unmet medical need and potentially offer a new therapeutic path for patients at a treatment deadlock.
CONDITIONS
Official Title
Open-label Study of Asciminib for CML-CP or CML-AP Patients With T315I Mutation Who Are Resistant, Intolerant or Ineligible to Ponatinib.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent prior to participation
- Male or female aged 18 years or older with diagnosis of CML-CP or CML-AP
- History of documented T315I mutation after at least one TKI and resistant, intolerant, or ineligible to ponatinib
- Not previously treated with asciminib or any other allosteric tyrosine kinase inhibitor
- Failure or intolerance to ponatinib at screening
- Ineligible for ponatinib according to investigator judgment
- Evidence of typical or atypical BCR::ABL1 transcripts measurable by PCR at screening
You will not qualify if you...
- Previous allogeneic hematopoietic stem-cell transplantation
- Cardiac or cardiac repolarization abnormalities
- Severe or uncontrolled medical conditions that pose safety risks or compromise protocol compliance
- History of clinical acute pancreatitis within 1 year or chronic pancreatitis (unless ponatinib-induced and resolved)
- History of acute or chronic liver disease
- Significant congenital or acquired bleeding disorder unrelated to cancer
- Other active malignancy within 3 years except treated basal cell skin cancer or carcinoma in situ
- Known HIV, chronic Hepatitis B or C infection
- Gastrointestinal disorders impairing drug absorption
- Treatment with moderate or strong CYP3A inducers or inhibitors that cannot be stopped one week before study
- Pregnant or nursing women
- Women of child-bearing potential
- Compound mutant T315I resistant to asciminib monotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Novartis Investigative Site
Bordeaux, France, 33076
Actively Recruiting
2
Novartis Investigative Site
Lille, France, 59037
Actively Recruiting
3
Novartis Investigative Site
Lyon, France, 69373
Actively Recruiting
4
Novartis Investigative Site
Nantes, France, 44093
Actively Recruiting
5
Novartis Investigative Site
Paris, France, 75475
Actively Recruiting
6
Novartis Investigative Site
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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