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 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT01370694
Eligibility Criteria:
Inclusion criteria:
* Histological diagnosis of CD20-positive follicular lymphoma, Grade 1, 2, or 3a (World Health Organization \[WHO\] 2008 classification) based on an excisional or incisional lymph node biopsy or a bone marrow biopsy.
* Ann Arbor Stage III or IV disease.
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
* Life expectancy \>3 months with no expected need of immediate intervention to treat life-threatening complications.
* Adequate organ function.
* Participants must agree to use an adequate method of contraception starting with the first dose of study drug through 12 months (for females) or 90 days (for males) after the last dose of study drug.
Exclusion criteria:
* Histological Grade 3b or with \>50% diffuse architectural pattern.
* Circulating malignant cells \>25,000/mm\^3
* Presence or history of central nervous system (CNS) disease (either CNS lymphoma or lymphomatous meningitis).
* Prior treatment with chemotherapy, rituximab, any other anti-CD20 compound, or any other type of anti-cancer compounds.
* Radiotherapy within 2 months prior to Cycle 1 Day 1.
* Current participation or has participated in a study with an investigational compound within 30 days prior to Cycle 1 Day 1.
* Concomitant disease that requires continuous therapy with prednisone at doses \>20 mg per day.
* Any medical contraindication for prednisolone as being dosed in the CVP regimen.
* Poorly controlled diabetes mellitus, as defined by institutional or local standards.
* Grade \>2 peripheral neuropathy.
* Has one of the following:
1. is human immunodeficiency virus (HIV)-positive
2. is Hepatitis B surface antigen positive (HBsAg+) or is positive for antibodies to Hepatitis B core antigen (anti-HBcAg+)
3. has antibodies to Hepatitis C virus
* Has one or more of the following:
1. Active tuberculosis based on institutional diagnostic criteria and local practice guidelines.
2. Evidence of a tuberculosis infection based on a chest X-ray (CXR) or computed tomography (CT) scan performed within 3 months of dosing.
3. History of a tuberculosis infection.
* Major surgical procedure within 4 weeks prior to Cycle 1 Day 1.
* Regular use (including "recreational" use) of any illicit drugs or recent history (within the last year) of drug or alcohol abuse or dependence.
* Pregnant or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01370694
Study Brief:
Protocol Section:
NCT01370694