Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-01-25 @ 5:00 AM
Study NCT ID:
NCT03381768
Status:
COMPLETED
Last Update Posted:
2021-02-24
First Post:
2017-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peptide Vaccination Against PD-L1 and PD-L2 in Relapsed Follicular Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061027', 'term': 'Programmed Cell Death 1 Ligand 2 Protein'}], 'ancestors': [{'id': 'D000082102', 'term': 'Immune Checkpoint Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D060887', 'term': 'B7 Antigens'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D000954', 'term': 'Antigens, Surface'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Fixed dose safety study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-23', 'studyFirstSubmitDate': '2017-12-08', 'studyFirstSubmitQcDate': '2017-12-18', 'lastUpdatePostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Clinical response according to Lugano criteria', 'timeFrame': '1 year', 'description': 'Changes in tumor size on CT'}, {'measure': 'Clinical response according to Lugano criteria', 'timeFrame': '1 year', 'description': 'Changes in tumor metabolism on PET'}, {'measure': 'Minimal residual disease', 'timeFrame': '1 year', 'description': 'measured by circulating tumor DNA'}], 'primaryOutcomes': [{'measure': 'Adverse events evaluated by CTCAE 4.03', 'timeFrame': '1 year follow up', 'description': 'Adverse events are graded 1-5 according to the criteria'}], 'secondaryOutcomes': [{'measure': 'Immune responses', 'timeFrame': '1 year', 'description': 'T-cell cytokine release towards target antigens'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PD-L1', 'PD-L2', 'peptide vaccine'], 'conditions': ['Follicular Lymphoma']}, 'descriptionModule': {'briefSummary': '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 with relapsed follicular lymphoma.', 'detailedDescription': '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 is watchful waiting until significant signs of progression or transformation. After chemotherapy, maintenance therapy is often used to increase disease control.\n\nThe microenvironment and immune escape mechanism are believed to play a major role in the persistence of the lymphoma. One escape mechanism is the PD-L1 and PD-L2 molecules expressed in the microenvironment of follicular lymphoma inhibiting the T-cells. By stimulating the T-cells to attack PD-L1 and PD-L2 expressing cells we hope to hamper the immunosuppressive tumor environment and establish immune tumor control.\n\n10 patients treated with standard therapy are needed for the trial and each patient will receive 15 vaccinations over the course of one year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically documented FL grade I-IIIa, with no sign of current transformation. Patients cured of transformed lymphoma are eligible.\n* A minimum of one line of induction therapy. Maintenance rituximab can continue along with the vaccination\n* At least partial response to the latest standard treatment\n* A minimum of 4 weeks since last treatment\n* Age ≥ 18\n* ECOG performance status of 0 or 1\n* Life expectancy ≥ 12 weeks\n* Adequate hematologic and end-organ function\n\nExclusion Criteria:\n\n* Progression with the presence of at least one GELF criteria or transformation at inklusion time.\n* Other active malignant diseases\n* Significant medical condition per investigators judgement e.g. severe Asthma/COLD, poorly regulated heart condition, insulin dependent diabetes mellitus.\n* Acute or chronic viral/bacterial infection e.g. HIV, CMV, EBV, hepatitis or tuberculosis\n* Serious known allergies or earlier anaphylactic reactions.\n* Known sensibility towards Montanide ISA-51\n* 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.\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03381768', 'briefTitle': 'Peptide Vaccination Against PD-L1 and PD-L2 in Relapsed Follicular Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'PD-L1 and PD-L2 Peptide Vaccination as Consolidation for Relapsed Follicular Lymphoma', 'orgStudyIdInfo': {'id': 'FL1701'}, 'secondaryIdInfos': [{'id': '2017-002000-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': '3 vaccines of PD-L2 peptide followed by 12 vaccines of PD-L2 and PD-L1 peptide, over the course of one year.', 'interventionNames': ['Biological: PD-L2 peptide', 'Biological: PD-L2 and PD-L1 peptide']}], 'interventions': [{'name': 'PD-L2 peptide', 'type': 'BIOLOGICAL', 'description': '100 ug PD-L2 peptide dissolved in DMSO and water mixed with 500ul montanide.', 'armGroupLabels': ['Study group']}, {'name': 'PD-L2 and PD-L1 peptide', 'type': 'BIOLOGICAL', 'description': '100 ug PD-L2 peptide and 100ug PD-L1 peptide dissolved in DMSO and water mixed with 500ul montanide.', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'state': 'RegionH', 'country': 'Denmark', 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'overallOfficials': [{'name': 'Uffe Klausen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hematological department, Herlev Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lars Møller Pedersen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief consultant', 'investigatorFullName': 'Lars Møller Pedersen', 'investigatorAffiliation': 'Herlev Hospital'}}}}