Actively Recruiting
Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase
Led by Augusta University · Updated on 2026-03-23
100
Participants Needed
7
Research Sites
510 weeks
Total Duration
On this page
Sponsors
A
Augusta University
Lead Sponsor
H
H. Jean Khoury Cure CML Consortium
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a multicenter Phase 2, non-randomized, open-label single-group frontline study administering asciminib in patients with newly diagnosed Chronic Myeloid Leukemia-Chronic Phase (CML-CP). The aim of this study is to evaluate the efficacy and safety of asciminib in newly diagnosed CML-CP. Patients will receive asciminib 80 mg orally once daily during the single asciminib phase. Response is determined by PCR (polymerase chain reaction) blood test during the study. Patients who have not achieved a response after 24 months (but no later than 36 months) of single agent asciminib will be offered the addition of a low dose tyrosine kinase inhibitor (low-TKI) namely dasatinib, imatinib, or nilotinib at the investigator's discretion. The following doses of the TKIs will be used: 1. Dasatinib 50 mg daily 2. Imatinib 300 mg daily 3. Nilotinib 300 mg daily Patients will discontinue study treatment if they experience disease progression, or unacceptable toxicity.
CONDITIONS
Official Title
Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Able and willing to give informed consent
- Newly diagnosed with CML in chronic phase within 6 months confirmed by bone marrow biopsy/aspirate
- Minimal prior TKI therapy for 30 days or less; other non-specific chemotherapy allowed without time limits
- ECOG performance status 0 to 2
- Adequate organ function including liver enzymes, kidney function, and bilirubin within specified limits
- Controlled blood pressure below 140/90 mmHg at enrollment
- Lipase level at or below 1.5 times institutional upper limit of normal
- Creatine phosphokinase less than 2.5 times institutional upper limit of normal
- Female patients must be postmenopausal, surgically sterile, or practice effective contraception
- Male patients must practice effective barrier contraception or true abstinence during study and 90 days after last dose
You will not qualify if you...
- Accelerated or blast phase CML
- Active second malignancy requiring treatment
- Recent or chronic pancreatitis within 12 months
- Prior treatment with asciminib
- Platelet count below 50,000/mm3, ANC below 500/mm3, or hemoglobin below 8 g/dL
- Significant cardiac history or abnormalities including recent myocardial infarction, arrhythmias, or long QT syndrome
- Pregnant or lactating women
- Use of strong CYP3A4 inhibitors, inducers, or narrow therapeutic index substrates at enrollment
- Inability to comply with lab schedule and patient-reported assessments
- Use of another investigational drug within 4 weeks prior to enrollment
- Serious medical or psychiatric conditions interfering with treatment
- Prior allogeneic stem cell transplant
- Known active hepatitis B infection
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Winship Cancer Institute Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States, 30912
Actively Recruiting
3
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
4
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14263
Actively Recruiting
5
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
6
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
7
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
J
James Sonnenberg
CONTACT
G
GCC Clinical Trials Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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