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 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT00007956
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed recurrent or refractory B-cell lymphoma after at least 1 standard chemotherapy regimen
* Low, intermediate, or high grade
* CD22 antigen on at least 30% of tumor cells by flow cytometry
* No lymphoblastic lymphoma, B-cell chronic lymphocytic leukemia, B-cell or pre-B-cell acute lymphocytic leukemia, or hairy cell leukemia
* Measurable disease
* Positive bone marrow not considered measurable
* Circulating tumor cells in peripheral blood considered measurable
* No CNS disease (leptomeningeal or parenchymal)
* No lymphomatous or infectious pulmonary parenchymal disease
* No baseline/pleural effusion
* Ineligible for or refused autologous or allogeneic bone marrow transplantation NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
* Over 18
Performance status:
* ECOG 0-2
Life expectancy:
* At least 3 months
Hematopoietic:
* Platelet count greater than 50,000/mm\^3
* Absolute granulocyte count greater than 750/mm\^3
Hepatic:
* Bilirubin less than 1.5 mg/dL
* SGPT less than 2 times upper limit of normal
* Albumin greater than 75% lower limit of normal
Renal:
* Creatinine no greater than 1.4 mg/dL OR
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* Ejection fraction greater than 40% by MUGA or echocardiogram
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No human anti-mouse antibody (HAMA) levels greater than 1 microgram/mL
* No condition that may require stenting of ureters, stabilization of impending pathological fractures, or relief of airway, bowel, or biliary tract obstruction
* No other concurrent illness that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
Chemotherapy:
* See Disease Characteristics
* At least 2 weeks since prior chemotherapy and recovered
* No concurrent chemotherapy
Endocrine therapy:
* No concurrent corticosteroids unless receiving stable maintenance dose prior to therapy
Radiotherapy:
* No prior radiotherapy
* No concurrent radiotherapy
Surgery:
* Not specified
Other:
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00007956
Study Brief:
Protocol Section:
NCT00007956