Recent Updates
Recently added Catalysts

Autologous FL vaccine

Phase 1

Lymphoma, Follicular | Monoclonal antibody | Oncology |Icon Plc|Last Updated: Jan 30, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment28
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01022255Autologous Vaccine for Follicular LymphomaPHASE1 COMPLETED 28 — — Jan 1, 2010Oct 1, 2013Jan 30, 20143 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
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 Endpoints
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)
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTAL -
Interventions
NameTypeDescription
Autologous FL vaccineBIOLOGICAL1.0 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)
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

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-C...

Countries:United States
Unlock Eligibility Criteria