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 @ 7:09 PM
Ignite Modification Date:
2025-12-24 @ 7:09 PM
NCT ID:
NCT00073957
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma, including any of the following:
* B-cell diffuse large cell variant
* Immunoblastic
* Mediastinal (thymic) large cell
* T-cell/histiocyte-rich
* Anaplastic large B-cell
* Intravascular large B-cell
* Lymphomatoid granulomatosis
* Relapsed or refractory disease after at least 1 prior chemotherapy regimen and requires further treatment
* Relapsed disease, defined as the following:
* Appearance of any new lesion OR increase of at least 50% in the size of a previously involved site
* 50% increase in greatest diameter of any previously identified node greater than 1 cm in the short axis OR in the sum of the perpendicular diameter (SPD) of more than 1 node
* Progressive disease, defined as the following:
* 50% increase from nadir in the SPD of any previously identified abnormal node
* Appearance of any new lesion during or at the end of therapy
* CD20-positive disease by immunohistochemistry
* Bidimensionally measurable disease
* At least 1 lesion at least 2.0 cm by CT scan
* Less than 25% bone marrow involvement by lymphoma
* No transformed lymphoma from indolent to aggressive
* No HIV- or AIDS-related lymphoma
* No hypocellular bone marrow
* No marked reduction in bone marrow precursors of 1 or more cell lines (e.g., granulocytic, megakaryocytic, or erythroid)
* No CNS lymphoma
* Ineligible for myeloablative therapy OR refused transplantation
* Ineligible for any other open yttrium Y 90 ibritumomab tiuxetan investigational protocols
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* WHO 0-2
Life expectancy
* At least 3 months
Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3
* Lymphocyte count no greater than 5,000/mm\^3 (for patients with small lymphocytic lymphoma)
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin no greater than 2.0 mg/dL
Renal
* Creatinine no greater than 2.0 mg/dL
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 1 year after study participation
* No concurrent serious nonmalignant disease or infection that would preclude study participation
* No human antimurine antibody reactivity
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
* No prior autologous bone marrow transplantation
* No prior peripheral blood stem cell rescue
* No prior failed stem cell collection
* Prior rituximab within the past 90 days allowed provided patient has fludeoxyglucose-avid disease that is also indium In 111 ibritumomab tiuxetan-avid disease in at least 1 lesion
* More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* Not specified
Radiotherapy
* No prior radioimmunotherapy
* No prior external beam radiotherapy (involved field or regional) to more than 25% of active bone marrow
Surgery
* More than 4 weeks since prior major surgery (except diagnostic surgery)
Other
* Recovered from all prior therapy
* More than 4 weeks since prior therapy for lymphoma
* More than 8 weeks since prior phase II investigational drugs
* No other concurrent antineoplastic therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00073957
Study Brief:
Protocol Section:
NCT00073957