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 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT05673460
Eligibility Criteria:
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
* Histologically confirmed B-cell malignancy:
* Chronic lymphocytic leukemia (CLL)
* Small lymphocytic lymphoma (SLL)
* Waldenström's macroglobulinemia (WM),
* Lymphoplasmacytic lymphoma (LPL)
* Other B-cell neoplasm
* Failed or intolerant to either at least 2 prior regimens given in combination or sequentially OR have received 1 prior Bruton's tyrosine kinase (BTK)-containing regimen when a BTK inhibitor is approved as first line therapy
* Have the ability to swallow and retain oral medication
* Is Japanese
Exclusion Criteria:
* Active Hepatitis B virus (HBV)/Hepatitis C virus (HCV) infection at study entry
* History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years
* Known history of human immunodeficiency virus (HIV) infection
* Clinically significant gastrointestinal abnormalities that might alter absorption (eg, gastric bypass surgery, gastrectomy)
* Underlying history of severe bleeding disorders
* History or concurrent condition of pneumonitis/interstitial lung disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05673460
Study Brief:
Protocol Section:
NCT05673460