Lymphoma, Follicular
Conditions
Keywords
autologous vaccine, follicular lymphoma, magnICON, plant-made vaccines, immune response
Brief summary
This phase I study will evaluate the safety and tolerability of an autologous idiotype vaccine manufactured by magnICON technology for patients with relapsed follicular lymphoma who are in complete or partial remission following non-antiCD20 containing salvage therapy. Data in terms of idiotype-specific immune responses will also be obtained.
Interventions
BIOLOGICALAutologous FL vaccine
1.0 mg of vaccine subcutaneously (s.c.) on Day 1, and followed by 125 µg GM-CSF s.c. at Day 1 -4, monthly until 8th vaccination, bimonthly until 12th vaccination (month 16)
Sponsors
Icon Genetics GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with toxicities as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI/CTCAE) version 3.0 grade >/= 3 to the magnICON generated idiotype (Id) vaccine | One month after sixth vaccination (=7 month after achievement of tumour remission and recovery of normal blood values) |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of humoral idiotype-specific immune responses | One month after sixth vaccination (=7 month after achievement of tumour remission and recovery of normal blood values) |
| Assessment of cellular idiotype-specific immune responses | One month after sixth vaccination (=7 month after achievement of tumour remission and recovery of normal blood values) |
| Long-term safety/tolerability as determined by the proportion of patients with toxicities as assessed by the FDA CBER Guidance for Industry Toxicity Grading Scale in Preventive Vaccine Clinical Trials and the NCI/CTCAE version 4.02 grade >/= 3 | Up to the conclusion of a 12 cycle vaccination phase (month 16) |
Countries
United States
Outcome results
None listed