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 @ 12:46 PM
Ignite Modification Date:
2025-12-24 @ 12:46 PM
NCT ID:
NCT00058461
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed B-cell non-Hodgkin's lymphoma OR acute lymphoblastic leukemia
* CD20+ (confirmed by flow cytometry of tumor tissue, involved marrow, or CD20 immunostaining)
* The following histologies are generally CD20+ and are eligible:
* Diffuse large B-cell lymphoma, mediastinal (thymic) large B-cell lymphoma, or follicular lymphoma, grade III (rare), documented by flow cytometry or appropriate immunohistochemistry, any stage
* Burkitt's lymphoma or atypical Burkitt's/Burkitt-like lymphoma, any stage
* B-cell acute lymphoblastic leukemia, with FABL3 morphology and/or demonstration of surface immunoglobin by flow cytometry
* Atypical precursor B-cell lymphoblastic lymphoma or other unusual histologies that are CD20+
* Measurable disease by clinical, radiographic, or histologic criteria
* Must be in first or later recurrence or have disease that is primarily refractory to conventional therapy
* No isolated CNS disease
* Performance status - ECOG 0-2
* At least 2 months
* Absolute neutrophil count ≥ 1,000/mm\^3\*
* Platelet count ≥ 100,000/mm\^3 (transfusion independent)\*
* Hemoglobin ≥ 10.0 g/dL (RBC transfusion allowed)\*
* Bilirubin ≤ 1.5 times normal
* ALT \< 2.5 times normal
* No chronic renal insufficiency
* Renal insufficiency allowed provided it is secondary to tumor lysis syndrome
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study treatment
* HIV negative
* No active uncontrolled infection
* Seizure disorder allowed if well controlled with anticonvulsants
* No CNS toxicity greater than grade II
* At least 24 hours since prior growth factor(s)
* At least 60 days since prior biologic (antineoplastic) therapy
* Prior stem cell transplantation allowed provided the following criteria are met:
* More than 60 days since transplantation
* Hematopoietic lab value requirements are met (See Hematopoietic)
* No evidence of graft-versus-host disease (if post-allogeneic transplantation)
* Prior monoclonal antibody therapy allowed (including rituximab)
* No other concurrent immunomodulating agents
* More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas)
* No other concurrent chemotherapy
* No concurrent steroids (except for rituximab infusion-related symptoms)
* At least 2 weeks since prior local palliative radiotherapy (small port)
* At least 6 weeks since prior substantial bone marrow radiotherapy
* At least 6 months since prior craniospinal radiotherapy or radiotherapy to 50% or more of the pelvis
* Concurrent radiotherapy to localized painful, airway-compromising, or other acute organ-threatening lesions allowed provided at least 1 measurable lesion is not irradiated
* Recovered from prior therapy
* No concurrent participation in another phase II study
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT00058461
Study Brief:
Protocol Section:
NCT00058461