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iVAC-CLL01: Patient-individualized Peptide Vaccination After First Line Therapy of CLL

NCT02802943 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2022-11-28

No results posted yet for this study

Summary

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

  • Leukemia, Chronic Lymphatic

Interventions

BIOLOGICAL

Peptide Vaccine

Individualized multi-peptide cocktail consisting of 300 μg each of 5 HLA class I and 4 HLA class II restricted peptides. The peptides for each individual patient will be selected from a warehouse consisting of 30 different peptides restricted by the 6 most common HLA class I allotypes (A\*01, A\*02, A\*03, A\*24, B\*07, B\*08) and 4 HLA class II peptides. Peptides will be administered subcutaneously. Vaccination will take place on d1, d4, d8, d15, d22 followed by vaccinations every 4 weeks for 1 year. The peptide warehouse is selected based on our data on the non-mutant HLA-presented antigenome of CLL identified as frequently presented CLL-associated T cell epitopes with a high potential for broad clinical application.

DRUG

Imiquimod

All patients will receive imiquimod (Aldara®) as local adjuvant, applied topically at the side of vaccination 18h to 24h prior to the vaccination.

Sponsors & Collaborators

  • Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

    collaborator OTHER

  • Klinikum Stuttgart

    collaborator OTHER

  • Marienhospital Stuttgart

    collaborator OTHER

  • Katharinenhospital Stuttgart

    collaborator UNKNOWN

  • University Hospital Tuebingen

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-05
Primary Completion
2022-09-30
Completion
2022-11-18

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02802943 on ClinicalTrials.gov