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 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT04681820
Eligibility Criteria:
Inclusion Criteria:
1. Male or female patients ≥18 years of age;
2. CML-CP patients when enrolled
Definition of diagnosis:
Bone marrow cytogenetic confirmation of Philadelphia chromosome of t (9;22) translocations and/or the presence of P210 BCR-ABL1 transcripts via molecular assessment;
Documented chronic phase CML will meet all the criteria defined as:
\< 15% blasts in peripheral blood and bone marrow \< 30% blasts plus promyelocytes in peripheral blood and bone marrow \< 20% basophils in the peripheral blood
≥ 100 x 109/L (≥ 100,000/mm3) platelets No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly
3. CML-CP patients without optimal response(warning or failure) when treated with imatinib or dasatinib.
4. Female patients of childbearing potential must have a negative serum pregnancy test;
5. Ability to provide written informed consent prior to any study related screening procedures being performed.
Exclusion Criteria:
1. Treatment with other tyrosine kinase inhibitor(s) except imatinib and dasatinib prior to study entry;
2. With any mutations as follows :T315I、Y253F/H、E255K/V、F359C/V/I (if there are any other mutations,at physicians' discretion );
3. Entry into another therapeutic clinical trial;
4. Concomitant diseases that, according to the investigator's judgment, pose a serious risk to the patient's safety or completion of the study;
5. History of neurological or psychiatric disorders, including epilepsy or dementia;
6. Major surgery within 4 weeks prior to Day 1 of study;
7. Patients with another primary malignancy,unless the other primary malignancy is currently stable or does not need active intervention;
8. Women of reproductive age or men who are unable to use adequate methods of contraception, including women who are pregnant or breastfeeding;
9. ECOG≥3;
10. Patients who are unable to compliance with study or follow-up procedures;
11. Allergic to any of the components in this trial;
12. Not appropriate to attend this trial judged by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04681820
Study Brief:
Protocol Section:
NCT04681820