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 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT00811733
Eligibility Criteria:
Inclusion Criteria:
* Confirmed and active Waldenstrom's Macroglobulinemia requiring treatment.
* Ambulatory and capable of all selfcare. Up and about more than 50% of waking hours.
* Adequate organ function.
* Detectable CD20 positive of the tumor cells.
* Measurable disease as defined by a monoclonal IgM paraprotein level greater than 1000 mg/dL.
Exclusion Criteria:
* Treatment of WM within the past 28 days.
* Treatment with rituximab or alemtuzamab within the past 3 months.
* Certain heart problems, chronic or current active infection not controlled with oral antibiotics, other current cancer or within last 5 years.
* Current participation in another interventional clinical study.
* Lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception.
* Active cerebrovascular disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00811733
Study Brief:
Protocol Section:
NCT00811733