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 @ 1:35 AM
Ignite Modification Date:
2025-12-25 @ 1:35 AM
NCT ID:
NCT00060294
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of Waldenstrom's macroglobulinemia confirmed by IgM gammopathy and bone marrow biopsy
* Presence of lymphoplasmacytic cells
* CD20+ plasma cell dyscrasia on the majority of malignant cells
* Bone marrow involvement of 20-50% by core needle biopsy of at least 1.5 cm in length
* Clinical indication for initiation of treatment, including 1 or more of the following characteristics:
* Symptoms associated with the disease (e.g., fatigue, asthenia, or painful adenopathy)
* Anemia
* IgM greater than 3 g/L
* Progression as indicated by a rate of IgM rise of more than 0.5 g over 6 months
* No myelodysplastic syndromes or profound hypocellularity of the bone marrow
PATIENT CHARACTERISTICS:
Age
* Over 18
Performance status
* WHO 0-2
Life expectancy
* More than 3 months
Hematopoietic
* Absolute neutrophil count greater than 1,500/mm\^3
* Total B-lymphocyte count less than 5,000/mm\^3
* Platelet count greater than 100,000/mm\^3
* No hyperviscosity syndrome
Hepatic
* Bilirubin no greater than 1.5 mg/dL
Renal
* Not specified
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 1 year after study completion
* No uncontrolled CNS disease
* No serious nonmalignant disease that would preclude study participation
* No other concurrent active malignancy except controlled skin cancer or prostate cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
* More than 4 months since prior rituximab
* No prior radioimmunotherapy
Chemotherapy
* No prior high-dose chemotherapy (unless patient has had prior back-up stem cell collections)
* More than 6 weeks since prior chemotherapy
Endocrine therapy
* More than 4 weeks since prior corticosteroids
Radiotherapy
* No prior radiotherapy
Surgery
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00060294
Study Brief:
Protocol Section:
NCT00060294