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Personalized Multi-peptide Vaccination in CLL Patients

NCT04688385 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-12-09

No results posted yet for this study

Summary

The aim of this study is to evaluate the efficiency along with safety and toxicity of a personalizied multi-peptide vaccine in combination with the TLR1/2 ligand XS15 in CLL patients undergoing ibrutinib-based regimes.

Conditions

Interventions

BIOLOGICAL

Multipeptide Vaccine+ XS15

Peptide vaccination will take place in CLL patients that achieved at least a partial remission with detectable MRD after at least 6 and less than 9 months of an ibrutinib-based treatment regime. MRD will be determined by flow cytometry. MRD positivity is defined as \> 10-4 CLL cells in peripheral blood or bone marrow. Patients will receive either ibrutinib monotherapy or combinational therapy before study treatment. Vaccination will be done under ibrutinib monotherapy (i.e. after the end of e.g. anti-CD20 treatment, if applicable).

Sponsors & Collaborators

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Helmut Salih, Prof.Dr. · CCU Translational Immunology, University Hospital Tuebingen,

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-23
Primary Completion
2024-10-17
Completion
2024-10-17

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT04688385 on ClinicalTrials.gov