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 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT00422656
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older
* Must have received prior therapy for their WM and have relapsed or refractory WM. Any number of prior therapies is acceptable
* Measurable disease, defined as presence of immunoglobulin M paraprotein with a minimum IgM level of equal to or greater than 2 times the ULN and over 10% of lymphoplasmacytic cells in bone marrow
* ECOG Performance Status 0,1, or 2
* Laboratory values as described in the protocol
* Life expectancy of greater than 12 weeks
Exclusion Criteria:
* Uncontrolled infection
* Other active malignancies
* CNS involvement
* Cytotoxic chemotherapy less than 3 weeks, or biologic therapy less than 2 weeks, or corticosteroids less than 2 weeks prior to registration.
* Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational
* Pregnant or nursing women
* Known to be HIV positive
* Radiation therapy less than 2 weeks prior to registration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00422656
Study Brief:
Protocol Section:
NCT00422656