Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Icon Genetics GmbH
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects with histologically proven follicular lymphoma (grade 1, 2, or 3a), in clinical relapse/progression requiring treatment
Subjects must have had first line treatment consisting of rituximab with or without rituximab maintenance therapy (i.e. rituximab monotherapy, R-CHOP, R-CVP, R-FND, etc)
At least 4 months since last rituximab exposure
Subjects may have had any number of prior treatment regimens. If enrolled with transformed follicular lymphoma, study subject must have had anthracycline in a previous regimen
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Life expectancy of at least 12 months
Presence of at least a 2x2 cm in diameter lymph node (either a single lymph node or combined volume of lymphoid tissue) accessible for excision; for histological confirmation of diagnosis and for manufacture of the vaccine
Measurable disease in neck, chest, abdomen, or pelvis as assessed by computed tomography (CT) scan such that response to 2nd line chemotherapy can be defined by the criteria of Cheson et al (JCO 2007; 25:579, see appendix 15.2 and ref 65). PET scan results are not required for enrollment
You may not be if
Exposure to rituximab or antiCD-20 directed therapy within the 4 months prior to enrollment
History of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection
Active clinically serious infections (\> grade 2 National Cancer Institute Common Toxic Criteria \[NCI-CTC\] version 3.0)
Symptomatic metastatic brain or meningeal tumors including lymphoma unless the patient is \> 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry
History of organ allograft
Patients undergoing renal dialysis
Clareo Health | Autologous Vaccine for Follicular Lymphoma
