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 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT01868035
Eligibility Criteria:
Inclusion Criteria:
* male or female subjects age 18 to 80 years, inclusive, with any International Prognostic Index score; treated with 6 or more cycles of first-line CHOP chemotherapy and achieved a PR, CRu, or CR
* de novo diffuse large B-cell NHL according to the REAL classification; Ann Arbor stage III, stage IV, or bulky stage II disease (any mass ≥10 cm in diameter)
* less than an average of 25% of the intratrabecular marrow space involved by NHL in bilateral bone marrow biopsy specimens or \<10% involvement with NHL from unilateral bone marrow biopsy; tumor tissue expressing the CD20 antigen
* ≥60% performance status on the Karnofsky Performance Scale and an anticipated survival of at least 3 months
* absolute neutrophil count (ANC) ≥1500 cells/mm3 and platelet count ≥100,000/mm3
* adequate renal function (serum creatinine \<1.5 × upper limit of normal \[ULN\]) and hepatic function (total bilirubin ≤2.0 × ULN and aspartate aminotransferase \<5 × ULN)
Exclusion Criteria:
* prior radiation, prior biological therapy, or prior chemotherapy other than first-line CHOP
* active bilateral obstructive hydronephrosis
* New York Heart Association class III or IV heart disease or other serious illness
* prior malignancy other than lymphoma (except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which they had been disease-free for \>5 years)
* human immunodeficiency virus infection
* HAMA positive
* brain or leptomeningeal metastases at any time since diagnosis
* active infection requiring intravenous anti-infectives
* pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01868035
Study Brief:
Protocol Section:
NCT01868035