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 @ 2:23 PM
Ignite Modification Date:
2025-12-24 @ 2:23 PM
NCT ID:
NCT04440059
Eligibility Criteria:
Key Inclusion criteria:
1. Clinical and histologically confirmed giant globulinemia Fahrenheit (WM Ii International Working Group Standards, IWWM-2, 2003) (Owen et al., 2003)
2. At least one treatment indication is met (7th WM International Working Group standards, IWWM-7) (Dimopoulos et al., 2014)
3. With the lowest serum IgM value \>2 times ULN as the efficacy evaluation index
4. ECOG physical strength score 0-2
5. Voluntary written informed consent prior to trial screening.
Key Exclusion Criteria:
1. Present or prior history of other malignant neoplasms, unless radical treatment has been performed and there is no evidence of recurrence or metastasis in the last 5 years
2. Amyloidosis and central nervous system (CNS) involvement caused by WM
3. Demonstrate disease transformation
4. Patients who had received autologous stem cell transplantation within the previous 6 months
5. A history of organ transplantation or allogeneic bone marrow transplantation
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04440059
Study Brief:
Protocol Section:
NCT04440059