ASCiminib, With or Without Dasatinib Combination, as a 2nd-Line Therapy to ADVANCE the Treatment … (NCT07538401) | Clinical Trial Compass
Not Yet RecruitingPhase 2
ASCiminib, With or Without Dasatinib Combination, as a 2nd-Line Therapy to ADVANCE the Treatment for Chronic Myelogenous Leukemia in Chronic Phase (ASC2ADVANCE)
45 participantsStarted 2026-04-25
Plain-language summary
This study is testing a new way to treat people with a type of blood cancer called chronic myeloid leukemia (CML) in chronic phase.
This study is for the patients whose first treatment with a drug called a tyrosine kinase inhibitor (TKI; standard therapy) did not work well and resistant to the TKI drug. The study is checking if a drug called Asciminib (having different way of action), used either by itself or with another drug called Dasatinib, can be a better second option to help control the CML.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients ≥18 years of age
. Diagnosis of CML in chronic phase as per WHO criteria based on the presence of BCR::ABL1 fusion gene by PCR at original diagnosis. Confirmation is recommended, if possible, by demonstrating the Philadelphia chromosome or variants by cytogenetics or FISH (Fluorescence In Situ Hybridization) in addition to bone marrow morphology confirming CML-CP. Patients with additional chromosomal abnormalities in addition to the Philadelphia chromosome are eligible. NGS testing at initial diagnosis is not required.
. Warning or failure to first line of TKI therapy at the time of screening due to resistance or suboptimal response (based on the ELN 2020 failure criteria)
. BCR::ABL1 transcript type is trackable with institutional RQ-PCR (Real-time Quantitative Polymerase Chain Reaction) testing for response assessment
. No prior or concurrent malignancies, except for adequately treated non-melanoma skin cancer, cervical carcinoma-in-situ, adequately treated Stage I or II cancer from which patient is in complete remission, or any other cancer from which patient has been disease free for a minimum of five years
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary outcome will be the proportion of patients achieving MMR, defined as a 3-log reduction or deeper (0.1% International Scale), after 24 weeks (6 cycles) of treatment with ASC as a second-line therapy.