Clinical trial · Interventional
Peptide Vaccination With PD-L1 and PD-L2 Peptides in Untreated Chronic Lymphatic Leukemia.
NCT03939234CI-TRIAL-00056650completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is investigating the efficacy of PD-L1 and PD-L2 peptides in untreated CLL patients with unmutated IGHV gene status.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-L1, PD-L2 peptides with Montanide ISA51 | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vaccination
- description
- Untreated CLL patients with unmutated IgHV gene with a cut of at maximum of 2 % mutations. According to guidelines from the European Research Initiative on CLL (ERIC).
- interventionNames
- Combination Product: PD-L1, PD-L2 peptides with Montanide ISA51
Primary outcomes (1)
- measure
- Clinical response according to IW-CLL
- timeFrame
- 1 year
- description
- Progressive disease (PD), stable disease (SD), partial response (PR), complete response (CR) calculated on basis of changes in circulating lymphocytes and lymphnode/spleen/liver size according to criteria from the international working group on CLL (IW-CLL).
Secondary outcomes (2)
- measure
- Immune response by elispot
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * CLL according to national guidelines (Lymphoma.dk). * Unmutated IGHV gene according to ERIC recommendations.(25) * No prior CLL directed treatment * Age ≥ 18 * Eastern cooperative oncology group (ECOG) performance status of 0 or 1 * No life-threatening conditions * Adequate bone marrow function: Neutrophils \> 1,0 x 109/l; Platelets \> 100 x 109/l * Adequate renal function: Glomeruli filtration rate (eGFR)/1,73 m2 \> 50 mL/min * Adequate liver function: Aspartate Aminotransferase \< 100 U/L * For fertile women: agreement to use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for at least 120 days after the last treatment. * For men: agreement to use contraceptive measures and agreement to refrain from donating sperm. Exclusion Criteria: * Other active malignant diseases requiring treatment. * Significant medical condition per investigators judgement e.g. severe Asthma or chronic obstructive lung disease (COLD), poorly regulated heart condition, insulin dependent diabetes mellitus. * Acute or chronic viral/bacterial infection e.g. human immunodeficiency virus (HIV), Cytomegalo virus (CMV), Epstein-barr virus (EBV), hepatitis or tuberculosis * Serious known allergies or earlier anaphylactic reactions. * Known sensibility towards Montanide ISA51 * 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. * Pregnant and breastfeeding women. * Fertile women not using secure contraception with a failure rate less than \< 1% * Psychiatric disorders that according to the investigator could influence compliance. * Treatment with other experimental drugs
References
Publications (1)
- DERIVEDKlausen U, Grauslund JH, Jorgensen NGD, Ahmad SM, Jonassen M, Weis-Banke SE, Martinenaite E, Pedersen LB, Lisle TL, Gang AO, Enggaard L, Hansen M, Holmstrom MO, Met O, Svane IM, Niemann CU, Pedersen LM, Andersen MH. Anti-PD-L1/PD-L2 therapeutic vaccination in untreated chronic lymphocytic leukemia patients with unmutated IgHV. Front Oncol. 2022 Nov 22;12:1023015. doi: 10.3389/fonc.2022.1023015. eCollection 2022. PMID 36483037