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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT01130194
Eligibility Criteria:
Inclusion Criteria:
* Patients older than 18 years of age
* Follicular lymphoma, newly diagnosed or previously treated but no more than 2 previous regimens
* Relapse of disease must be greater than 6 months after last chemotherapy
* Stages II, III or IV
* Eastern Cooperative Group (ECOG) performance status of 0 or 1. If ECOG 2-4, poor performance must by due to lymphoma as judged by study investigator.
* Patient signed written informed consent
* Adequate renal function defined as a glomerular filtration rate (GFR) \> 60 ml/min
* Adequate blood counts (absolute neutrophil count ≥ 1,500, platelets ≥100,000), unless low due to lymphomatous involvement of the bone marrow.
* No known allergies to the chemotherapeutic agents
* No other major disabling co morbidities
* Adequate pulmonary function, defined as corrected DLCO greater than 70% of predicted and FEV1 (forced expiratory volume in one second, a test of respiratory function) greater than 50% of predicted.
* Adequate hepatic function as assessed by study investigator
* Adequate cardiac function, defined as baseline MUGA (Multiple gated acquisition, a test of heart function) \>50%
Exclusion Criteria:
* Stage I follicular lymphoma
* ECOG performance status ≥ 2, unless due to lymphoma
* Patient refuses to sign written informed consent
* Poor renal function defined as GFR \<60ml/min
* Abnormal liver function as assessed by study investigator
* Poor bone marrow reserve (absolute neutrophil count \<1,500 and/or platelets \< 100,000) not attributable to lymphomatous involvement of the bone marrow.
* Hypersensitivity to the chemotherapeutic agents
* Major disabling co morbidities like uncontrolled severe HTN (hypertension), active coronary artery disease, liver cirrhosis.
* Previously diagnosed malignancy other than basal or squamous cell carcinoma of the skin diagnosed \<5 years prior.
* Central nervous system disease
* History of advanced cardiac disease (Active angina, Congestive heart failure with a LVEF (left ventricular ejection fraction) \<50%).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01130194
Study Brief:
Protocol Section:
NCT01130194