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 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT01234467
Eligibility Criteria:
Inclusion Criteria:
* Patients with previously untreated , histologically confirmed, diffuse large B-cell lymphoma (DLBCL), immunophenotyped for CD20
* Age greater than or equal to 65 years
* Stage II-IV
* Measurable disease including lesions that can be accurately measured in 2 dimensions by CT and have a greatest transverse diameter of 1cm or greater, and/or by bone marrow histopathology.
* ECOG performance status of 0-3
* Deemed poor candidate for CHOP-R due to ejection fraction less than or equal to 45%, ECOG performance status of 2, or in the opinion of the treating physician, patient would not tolerate administration of CHOP-R chemotherapy for other reasons,
* Life expectancy of at least 3 months;
* Documented negative serologic testing for HIV, Hepatitis B (unless positive due to prior vaccination), and hepatitis C within the year prior to enrollment
* Adequate bone marrow function (without transfusion support within one week of screening) function:
* Hemoglobin \> 8 g/dL
* Absolute neutrophil count (ANC) \>1000 cells/mm3
* Platelet count \> 75,000/mm3
* Adequate hepatic and renal function as demonstrated by:
* Aspartate aminotransferase (AST) \< 2.5 x upper limit of normal (ULN)
* Total serum bilirubin \< 2.5 x ULN
* Serum creatinine \< 1.5 x ULN
* If sexually active male of reproductive capability, has agreed to use a medically accepted form of contraception from time of enrollment to completion of all follow-up study visits
* Signed an institutional review board (IRB) approved informed consent document
Exclusion Criteria:
* Central nervous system involvement by lymphoma
* History of previous allergic reactions to compounds of similar biological or chemical composition as rituximab or bendamustine
* Medical or other condition that would represent an inappropriate risk to the patient or would likely compromise achievement of the primary study objective.
* Other active malignancies (except: non-melanoma skin cancer, cervical carcinoma in situ without evidence of disease, prostatic intraepithelial neoplasia without evidence of prostate cancer)
* Patients on strong inhibitors of CYP1A2.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT01234467
Study Brief:
Protocol Section:
NCT01234467