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:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT04102150
Eligibility Criteria:
Inclusion Criteria:
* Participants with relapsed or refractory adult T-cell leukemia/lymphoma (ATL) who have history of treatment with mogamulizumab or are mogamulizumab intolerant, contraindication after treatment with at least 1 medication regimen
* Aged ≥20 years or older at the time of signing the informed consent
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2
* At least 1 evaluable lesion
* Participants who have defined laboratory criteria
* Life expectancy ≥ 3 months
Exclusion Criteria:
* A presence of central nervous system involvement at the time of screening tests
* Have poorly controlled complication (eg. chronic congestive heart failure, unstable angina
* ≥ Grade 3 neuropathy
* QT interval corrected using Fridericia's method (QTcF) \>470 ms
* Has an uncontrolled infection
* Participants who use corticosteroids over 10 mg/day
* Receipt of allogeneic hematopoietic stem cell transplantation
* History of, or concurrent, malignant tumors
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT04102150
Study Brief:
Protocol Section:
NCT04102150