Autologous Vaccine for Follicular Lymphoma
Phase I Study of an Autologous Recombinant Idiotypic Vaccine Manufactured by magnICON® Technology for the Treatment of Patients With Relapsed or Transformed Follicular Lymphoma
1 other identifier
interventional
28
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2010
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2009
CompletedFirst Posted
Study publicly available on registry
December 1, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedJanuary 30, 2014
January 1, 2014
3.8 years
November 30, 2009
January 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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)
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
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)
Eligibility Criteria
You may qualify 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 qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Unknown Facility
Burbank, California, 91505, United States
Unknown Facility
Dallas, Texas, 75246, United States
Unknown Facility
Dallas, Texas, 75390-8590, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Company Study Director
Icon Genetics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2009
First Posted
December 1, 2009
Study Start
January 1, 2010
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
January 30, 2014
Record last verified: 2014-01