ASCiminib, With or Without Dasatinib Combination, as a 2nd-Line Therapy to ADVANCE the Treatment β¦ (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 (TKIΝΎ 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 range18 Years
SexALL
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Inclusion criteria
β. Patients β₯18 years of age
β. 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.
β. 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)
β. BCR::ABL1 transcript type is trackable with institutional RQ-PCR (Real-time Quantitative Polymerase Chain Reaction) testing for response assessment
β. 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
β. Patients must be ASC naΓ―ve
β. Agree to conduct somatic mutation profile testing at enrollment
β. Adequate organ function defined by:
Exclusion criteria
β. Failure to provide informed consent
β. Prior stem cell or bone marrow transplant
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.