Status:
COMPLETED
Peptide Vaccination Against PD-L1 and PD-L2 in Relapsed Follicular Lymphoma
Lead Sponsor:
Lars Møller Pedersen
Conditions:
Follicular Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
An open phase-1, first-in-human, clinical trial investigating the safety and immunological effects of peptide vaccination with Programmed Death Ligand 1 and 2 (PD-L1 and PD-L2) peptides in patients wi...
Detailed Description
Follicular lymphoma (FL) is the the most common of the indolent lymphomas, with an incidence in Denmark of 220 per year. In 90% of the cases the disease is incurable why the treatment strategy often i...
Eligibility Criteria
Inclusion
- Histologically documented FL grade I-IIIa, with no sign of current transformation. Patients cured of transformed lymphoma are eligible.
- A minimum of one line of induction therapy. Maintenance rituximab can continue along with the vaccination
- At least partial response to the latest standard treatment
- A minimum of 4 weeks since last treatment
- Age ≥ 18
- ECOG performance status of 0 or 1
- Life expectancy ≥ 12 weeks
- Adequate hematologic and end-organ function
Exclusion
- Progression with the presence of at least one GELF criteria or transformation at inklusion time.
- Other active malignant diseases
- Significant medical condition per investigators judgement e.g. severe Asthma/COLD, poorly regulated heart condition, insulin dependent diabetes mellitus.
- Acute or chronic viral/bacterial infection e.g. HIV, CMV, EBV, hepatitis or tuberculosis
- Serious known allergies or earlier anaphylactic reactions.
- Known sensibility towards Montanide ISA-51
- Any active autoimmune diseases e.g. autoimmune neutropenia, thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, scleroderma, myasthenia gravis, autoimmune glomerulonephritis, autoimmune adrenal deficiency, autoimmune thyroiditis etc.
- Pregnancy
Key Trial Info
Start Date :
December 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 12 2020
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03381768
Start Date
December 12 2017
End Date
February 12 2020
Last Update
February 24 2021
Active Locations (1)
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1
Herlev Hospital
Herlev, RegionH, Denmark, 2730