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 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT01662102
Eligibility Criteria:
Inclusion Criteria:
* 18 to 75 years of age.
* Previously untreated with histologically confirmed grade 1, 2 or 3a cluster of differentiation-20 (CD20)-positive follicular lymphoma, with any of the GELF (Groupe d'Etude de Lymphomes Folliculaires) treatment criteria prior to induction.
* Achieved a response to induction treatment with either rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) (6 cycles of R-CHOP21 or R-CHOP14), rituximab-cyclophosphamide, vincristine and prednisone (R-CVP) (6 cycles), or rituximab-bendamustine (R-B) (4 to 6 cycles).
* Must have completed all doses of the induction treatment, except for the modifications allowed in the protocol.
Exclusion Criteria:
* Transformation to high grade lymphoma (secondary to "low grade" follicular lymphoma \[FL\]).
* Grade 3b follicular lymphoma.
* Primary follicular lymphoma of the skin or gastrointestinal tract.
* Previous treatment of follicular lymphoma.
* Altered renal and hepatic function.
* Known human immunodeficiency virus (HIV) infection and/or active hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection
* Serious co-morbid conditions (for example, ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease).
* Life expectancy \< 6.
* Must have:
* Platelet count ≥ 100x10\^9/L.
* Bone marrow infiltration \<25%.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01662102
Study Brief:
Protocol Section:
NCT01662102