Clinical trial · Interventional
iVAC-CLL01: Patient-individualized Peptide Vaccination After First Line Therapy of CLL
NCT02802943CI-TRIAL-00062353completedPhase 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)
The aim of this study is to induce a peptide-specific immune response in CLL patients by multi-peptide vaccination with a patient-individualized peptide cocktail.
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 |
|---|---|---|---|
| Leukemia, Chronic Lymphatic | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imiquimod | Drug | Imiquimod | ALIAS |
| Peptide Vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Peptide Vaccine MRD +
- description
- MRD-positive (MRD+) patients (flow cytometry based, CLL cells in peripheral blood or bone marrow ≥ 10-4 6-10 weeks after the end of first line treatment)
- interventionNames
- Biological: Peptide Vaccine
- Drug: Imiquimod
- type
- EXPERIMENTAL
- label
- Peptide Vaccine MRD-
- description
- MRD-negative (MRD-) patients (flow cytometry based, CLL cells in peripheral blood and bone marrow \<10-4 6-10 weeks after the end of first line treatment)
- interventionNames
- Biological: Peptide Vaccine
- Drug: Imiquimod
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
1. Documented diagnosis of CLL/SLL according to IWCLL guidelines. For Screening phase: * No pretreatment of CLL/SLL * Ability to mount an immune response: Positive immunresponse to EBV/CMV peptide mix (analyzed in 12 day recall IFNγ ELISPOT). For Vaccination phase: • Achievement of response (at least PR according to IWCLL guidelines) after first-line therapy according to treating physicians choice. 2. HLA typing positive for HLA alleles of peptides included in the warehouse with proven immunogenicity: HLA-A\*01, A\*02, A\*03, A\*24, B\*07, B\*08. 3. Ability to understand and voluntarily sign an informed consent form. 4. Age ≥ 18 years at the time of signing the informed consent form. 5. Ability to adhere to the study visit schedule and other protocol requirements. 6. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2. 7. Negative serological Hepatitis B and C test or negative PCR in case of positive serological test without evidence of an active infection, negative HIV test within 6 weeks prior to randomization.
References
Publications (1)
- DERIVEDHeitmann JS, Jung S, Wacker M, Maringer Y, Nelde A, Bauer J, Denk M, Hoenisch-Gravel N, Richter M, Oezbek MT, Dubbelaar ML, Bilich T, Pumptow M, Martus P, Illerhaus G, Denzlinger C, Steinbach F, Aulitzky WE, Muller MR, Dorfel D, Rammensee HG, Salih HR, Walz JS. Warehouse-based, immunopeptidome-guided design of personalised peptide vaccines shows feasibility in clinical trial evaluation in CLL patients. Front Immunol. 2024 Nov 26;15:1482715. doi: 10.3389/fimmu.2024.1482715. eCollection 2024. PMID 39660140