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 @ 3:59 PM
Ignite Modification Date:
2025-12-24 @ 3:59 PM
NCT ID:
NCT00010192
Eligibility Criteria:
Inclusion Criteria:
* Histologically or immunophenotypically proven CD20-positive B-cell lymphoproliferative disorder
* Recurrent or progressive low-grade B-cell lymphoma with at least one prior chemotherapy regimen (may have included monoclonal antibody)
* Relapsed intermediate-grade or high-grade B-cell lymphoma or B-lineage acute lymphoblastic leukemia and patient not a candidate for, refused, or failed prior hematopoietic stem cell transplantation
* No chronic lymphocytic leukemia or lymphoma with more than 5,000/mm3circulating lymphoma cells
* Measurable or evaluable disease
* Must have failed standard curative therapy
* No CNS or leptomeningeal metastasis
* Performance status - Karnofsky 70-100%
* Performance status - ECOG 0-1
* At least 4 months
* Absolute neutrophil count at least 1,000/mm\^3
* Hemoglobin at least 10 g/dL (transfusion allowed)
* Platelet count at least 50,000/mm\^3
* AST no greater than upper limit of normal (ULN)
* Bilirubin no greater than 1.5 times ULN
* Hepatitis B surface antigen negative
* Creatinine no greater than ULN
* No prior unstable coronary artery disease
* No New York Heart Association class III or IV congestive heart failure
* DLCO and FEV1 at least 50% of predicted
* HIV negative
* No other concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
* No infection requiring IV antibiotic therapy within the past 4 weeks
* No other major illness that would preclude study
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* See Disease Characteristics
* Prior antibody therapy allowed
* Prior interleukin-2 or interferon alfa allowed
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy
* At least 4 weeks since prior systemic corticosteroids
* At least 4 weeks since prior radiotherapy
* At least 4 weeks since prior surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00010192
Study Brief:
Protocol Section:
NCT00010192