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 @ 6:29 PM
Ignite Modification Date:
2025-12-24 @ 6:29 PM
NCT ID:
NCT00142168
Eligibility Criteria:
Inclusion Criteria:
* Clinicopathological diagnosis of Waldenstrom's macroglobulinemia using consensus panel criteria
* Age 18 years or older
* CD20 positive based on any previous bone marrow immunohistochemistry or flow cytometric analysis
* All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study
* Measurable disease, defined as presence of immunoglobulin M paraprotein with a minimum IgM level of equal to or greater than 2 times the upper limit of normal.
* ECOG performance status of 0-2
* Absolute neutrophil count ≥ 100,000,000/L
* Platelet count ≥ 50,000,000,000/L
* Hemoglobin \> 8 g/dL
* Serum creatinine \< 2.5 mg/dL
* Total bilirubin \< 1.5 mg/dL
* AST and ALT \< 2.5 x ULN
* Disease free of prior malignancies fir 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast
Exclusion Criteria:
* Any serious medical condition, laboratory abnormality, or psychiatric illness
* Pregnant or lactating women
* Prior therapy with rituximab or CC-5103
* Known hypersensitivity to thalidomide
* Development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
* Concurrent use of other anti-cancer agents or treatments
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00142168
Study Brief:
Protocol Section:
NCT00142168