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:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-25 @ 4:35 AM
NCT ID:
NCT00931918
Eligibility Criteria:
Each patient must meet all of the following inclusion criteria to be enrolled in the study:
Inclusion Criteria:
* Patients with previously untreated DLBCL that has been sub classified as the non-GCB subtype.
* At least 1 measurable tumor mass.
* Availability of paraffin block with sufficient tumor tissue.
* No evidence of central nervous system lymphoma.
* Eastern Cooperative Oncology Group (ECOG) performance status of \< or equal to 2.
* Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse.
* Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse.
Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
Exclusion Criteria:
* Diagnosed or treated for a malignancy other than DLBCL within 2 years of first dose or evidence of active malignancy other than DLBCL.
* Peripheral neuropathy of Grade 2 or greater.
* Known history of human immunodeficiency virus (HIV) infection, unless receiving highly active antiretroviral therapy (HAART).
* Active infection requiring systemic therapy.
* Major surgery within 2 weeks before first dose.
* Patients with a left ventricular ejection fraction (LVEF) or less than 45%.
* Myocardial infarction with 6 months of enrollment or evidence of current uncontrolled cardiovascular conditions as described in the protocol.
* History of allergic reaction/ hypersensitivity attributable to boron, mannitol, polysorbate 80 or sodium citrate dehydrate, or anaphylaxis or immunoglobulin E (IgE)-mediated hypersensitivity to murine proteins or to any component of rituximab.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00931918
Study Brief:
Protocol Section:
NCT00931918