Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-25 @ 3:07 AM
NCT ID:
NCT04948333
Eligibility Criteria:
Key Inclusion criteria:
* Signed informed consent must be obtained prior to participation in the study
* Male or female patients with a diagnosis of CML-CP ≥ 18 years of age
* Treatment with a minimum of 2 or more prior TKIs (i.e. imatinib, nilotinib, dasatinib, bosutinib, radotinib or ponatinib)
* Warning or 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
* Adequate end organ function (as per central laboratory tests)
Key Exclusion criteria:
* Known presence of the BCR::ABL1 T315I mutation at any time prior to study entry
* Known second chronic phase of CML after previous progression to AP/BC
* Previous treatment with a hematopoietic stem-cell transplantation
* Patient planning to undergo allogeneic hematopoietic stem cell transplantation
* Uncontrolled cardiac repolarization abnormality
* 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
* History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis
* Testing for Hepatitis B surface antigen (HbsAg) and Hepatitis B core antibody (HBcAb / anti HBc) will be performed at screening. Patients with active Hepatitis B Virus (HBV) infection (hepatitis B surface antigen \[HbsAg\] positive) will be excluded
Other Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT04948333
Study Brief:
Protocol Section:
NCT04948333