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Phase I Study of an Autologous Recombinant Idiotypic Vaccine Manufactured by magnICON® Technology for the Treatment of Patients With Relapsed or Transformed Follicular Lymphoma
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.
Details
| Lead sponsor | Icon Genetics GmbH |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 28 |
| Start date | 2010-01 |
| Completion | 2013-10 |
Conditions
- Lymphoma, Follicular
Interventions
- Autologous FL vaccine
Primary outcomes
- 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)
Countries
United States