Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chroni… (NCT06236724) | Clinical Trial Compass
RecruitingPhase 2
Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.
United States50 participantsStarted 2024-01-31
Plain-language summary
To learn if asciminib can help to control CML. The safety and effects of this drug will also be studied.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult participants age ≥18 years.
* Participants must have a diagnosis of Ph-positive or BCR::ABL1 positive CML in early chronic phase (i.e., time from diagnosis ≤12 months).
* Participants who received prior hydroxyurea, 1 to 2 doses of cytarabine, and/or an FDA approved TKI for \<30 days are eligible.
* Participants with additional chromosomal abnormalities at diagnosis (early disease) and no other criteria for accelerated phase will be eligible for this study.
* ECOG performance status ≤2.
* Participants must have adequate end organ function, defined as the following: total bilirubin ≤1.5x ULN (unless secondary to Gilbert's disease, in which case should be ≤2.5x ULN), SGPT or SGOT ≤3x ULN, creatinine clearance ≥30mL/min calculated using modified Cockcroft-Gault.
* Ability to understand and the willingness to sign a written informed consent document.
* The effects of asciminib on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:
* Postmenopausal (no me…
What they're measuring
1
Safety and adverse events (AEs)
Timeframe: Through study completion; an average of 1 year.