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 @ 3:33 AM
Ignite Modification Date:
2025-12-25 @ 3:33 AM
NCT ID:
NCT04014205
Eligibility Criteria:
Inclusion Criteria:
1. Signed Informed Consent.
2. Age ≥ 18 years.
3. Part 1: Patients with histologically confirmed relapsed or refractory B-cell malignancies, including Grades 1-3a FL, MZL, MCL, and CLL/SLL.
Part 2: Patients with histologically confirmed B-cell malignancies including r/r FL, r/r MZL and CLL/SLL with/without prior treatment.
4. Life expectancy (in the opinion of the investigator) of ≥ 4 months.
5. ECOG performance status of 0 \~1.
6. Must have adequate organ function.
7. Negative test results for HBV (\[HBsAg (-)\] and non-active HBV or HCV infection
Exclusion Criteria:
1. Pregnant or breast-feeding or intending to become pregnant during the study.
2. Prior treatment with systemic immunotherapeutic agents.
3. Known allergies to Orelabrutinib (ICP-022) or its excipients or infection with HIV.
4. Treatment with any chemotherapeutic agent, or any other investigational therapies within 4 weeks prior to first dose of the study drug.
5. History of allogeneic stem-cell (or other organ) transplantation or confirmed progressive PML.
6. Any external beam radiation therapy within 6 weeks prior to the first dose of the study drug.
7. Concurrent use of warfarin or other vitamin K antagonists or anticoagulation therapies or strong CYP3A inhibitor.
8. Active uncontrolled infections.
9. Recent infection requiring IV anti-infective treatment that was completed ≤ 14 days before the first dose of study drug.
10. Unresolved toxicities from prior anti-cancer therapy.
11. Medically apparent CNS lymphoma or leptomeningeal disease.
12. Current or previous history of CNS disease.
13. Major surgery or significant traumatic injury \< 28 days prior to the first dose of the study drug.
14. Patients with another invasive malignancy in the last 2 years.
15. Significant cardiovascular disease or active pulmonary disease.
16. Received systemic immunosuppressive medications.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04014205
Study Brief:
Protocol Section:
NCT04014205