Asciminib in Monotherapy for Chronic Myeloid Leukemia in Chronic Phase (CML-CP) With and Without … (NCT04666259) | Clinical Trial Compass
CompletedPhase 3
Asciminib in Monotherapy for Chronic Myeloid Leukemia in Chronic Phase (CML-CP) With and Without T315I Mutation
United States56 participantsStarted 2021-05-25
Plain-language summary
This study was a multicenter Phase IIIb open-label, three-cohort study of asciminib in patients with CML-CP without T315I mutation who have had at least 2 prior TKIs and CML-CP harboring the T315I mutation with at least 1 prior TKI
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria
✓. Written informed consent must be obtained and signed prior to participation in the study
✓. Male or female patients with a diagnosis of CML-CP ≥ 18 years of age
✓. Patients must meet all of the following laboratory values at the screening visit:
✓. Mutation Analysis testing performed 6 months before study entry
✓. Prior treatment with a minimum of:
✓. Failure (adapted from the 2020 ELN Recommendations) or intolerance to the most recent TKI therapy at the time of screening
✓. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
✓. Evidence of typical BCR-ABL1 transcript \[e14a2 and/or e13a2\] at the time of screening which are amenable to standardized RQ-PCR quantification.
Exclusion criteria
✕. Known second chronic phase of CML after previous progression to AP/BC
✕. Previous treatment with a hematopoietic stem-cell transplantation
✕. Cardiac or cardiac repolarization abnormality, including any of the following:
✕. Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g. uncontrolled diabetes, active or uncontrolled infection, pulmonary hypertension)
What they're measuring
1
Number of Participants With Adverse Events and Serious Adverse Events for Cohorts A and B up to 24 Weeks
✕. History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis
✕. Known presence of significant congenital or acquired bleeding disorder unrelated to cancer
✕. History of other active malignancy within 3 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively
✕. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass surgery)