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 @ 5:28 PM
Ignite Modification Date:
2025-12-24 @ 5:28 PM
NCT ID:
NCT00081068
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of Waldenstrom's macroglobulinemia (lymphoplasmacytic lymphoma)
* Immunoglobulin (Ig) M, IgG, and IgA paraprotein
* Measurable monoclonal paraprotein
* Failed at least 1 prior first-line therapy (alkylator agent, nucleoside analogue, or rituximab)
* CD52-positive tumor determined by either bone marrow immunohistochemistry or flow cytometry
PATIENT CHARACTERISTICS:
Age
* Over 18
Performance status
* ECOG 0-2
Life expectancy
* At least 6 months
Hematopoietic
* Absolute neutrophil count ≥ 500/mm\^3
* Platelet count ≥ 25,000/mm\^3
Hepatic
* SGOT ≤ 2.5 times upper limit of normal (ULN)
* Bilirubin ≤ 2.5 times ULN
Renal
* Creatinine ≤ 2.5 mg/dL (\> 2.5 mg/dL allowed if due to disease)
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective double-method contraception during and for 6 months after study participation
* No serious comorbid disease
* No uncontrolled bacterial, fungal, or viral infection
* No other active malignancy
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
* No prior alemtuzumab
* More than 3 months since other prior monoclonal antibody therapy
Chemotherapy
* See Disease Characteristics
* More than 21 days since prior chemotherapy
Endocrine therapy
* More than 21 days since prior steroid therapy
Radiotherapy
* More than 21 days since prior radiotherapy
Surgery
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00081068
Study Brief:
Protocol Section:
NCT00081068