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

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ClinicalTrials.gov Identifier: NCT02802943
Recruitment Status : Recruiting
First Posted : June 16, 2016
Last Update Posted : September 17, 2019
Sponsor:
Collaborators:
Robert Bosch Gesellschaft für Medizinische Forschung mbH
Klinikum Stuttgart
Marienhospital Stuttgart
Katharinenhospital Stuttgart
Information provided by (Responsible Party):
University Hospital Tuebingen

Brief 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.

Condition or disease Intervention/treatment Phase
Leukemia, Chronic Lymphatic Biological: Peptide Vaccine Drug: Imiquimod Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model 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).

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)

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: iVAC-CLL01: Patient-individualized Peptide Vaccination After First Line Therapy of CLL
Study Start Date : October 5, 2016
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod

Arm Intervention/treatment
Experimental: Peptide Vaccine MRD +
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)
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.

Experimental: Peptide Vaccine MRD-
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)
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.




Primary Outcome Measures :
  1. Induction of peptide-specific T cell responses [ Time Frame: 6 month after start of therapy ]

    The rate of patients with induction of peptide-specific T cell responses within a maximum of 6 month after start of therapy will be the primary endpoint for efficacy.

    Analysis of the primary endpoint= induction of immune response:

    The induction of peptide-specific T cell responses will be determined by IFNγ ELISPOT.

    T cell responses will be considered to be positive when >15 spots/well (IFNγ ELISPOT) were counted and the mean spot count per well is at least 3-fold higher than the mean number of spots in the negative control wells (according to the cancer immunoguiding program guidelines).



Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 6 month after start of therapy ]
    Secondary endpoints will be the overall survival, the disease free survival and the remission status at the end of study, the achievement of MRD-negativity or reduction in MRD-positive patients as well as safety and toxicity (CTCAE V 4.03)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802943


Contacts
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Contact: Helmut Salih, Prof. MD +49 (0)7071/2983275 helmut.salih@med.uni-tuebingen.de
Contact: Juliane Walz, Dr. med. +49 (0)7071/2983275 juliane.walz@med.uni-tuebingen.de

Locations
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Germany
Diakonie-Klinikum Stuttagrt Recruiting
Stuttgart, Baden-Wuerttemberg, Germany, 70176
Contact: Jochen Greiner, Prof. Dr. med.    +49 711 9913501    greiner@diak-stuttgart.de   
Contact: Matthias Bichler, Dr.med.       bichler@diak-stuttgart.de   
Robert-Bosch-Krankenhaus Abteilung fuer Haematologie, Onkologie und Palliativmedizin Recruiting
Stuttgart, Baden-Wuerttemberg, Germany, 70376
Contact: Matthias Voehringer, Dr. med.    +49 711 8101 ext 3506      
Contact: Martin Kaufmann, Dr.med.    +49 711 8101 ext 3506      
University Hospital Tuebingen Not yet recruiting
Tuebingen, Baden-Wuerttemberg, Germany, 72076
Contact: Helmut R Salih, Prof.    +49(0)707129 ext 83275    helmut.salih@med.uni-tueningen.de   
Contact: Juliane walz, PD Dr.    +49(0)707129 ext 68746    julian.walzr@med.uni-tuebingen.de   
Marienhospital Recruiting
Stuttgart, Baden-Württemberg, Germany, 70199
Contact: Claudio Denzlinger, Prof.Dr.med.    +49 (0)711/64898101    claudio.denzlinger@vinzenz.de   
Contact: Serkan Karakaya, Dr. med.       serkan.karakaya@vinzenz.de   
Katharinenhospital Recruiting
Stuttgart, BW, Germany, 70174
Contact: Gerald Illerhaus, Prof. Dr. med.    : 49 711 27830401      
Contact: Claudia Riechel, Dr. med.         
Sponsors and Collaborators
University Hospital Tuebingen
Robert Bosch Gesellschaft für Medizinische Forschung mbH
Klinikum Stuttgart
Marienhospital Stuttgart
Katharinenhospital Stuttgart

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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02802943     History of Changes
Other Study ID Numbers: iVAC-CLL01:
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Keywords provided by University Hospital Tuebingen:
CLL, Peptid Vaccination
Additional relevant MeSH terms:
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Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-Cell
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Imiquimod
Vaccines
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Antineoplastic Agents
Interferon Inducers