iVAC-CLL01: Patient-individualized Peptide Vaccination After First Line Therapy of CLL
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02802943 |
Recruitment Status :
Completed
First Posted : June 16, 2016
Last Update Posted : November 28, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Leukemia, Chronic Lymphatic | Biological: Peptide Vaccine Drug: Imiquimod | Phase 2 |

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 |
Actual Study Start Date : | October 5, 2016 |
Actual Primary Completion Date : | September 30, 2022 |
Actual Study Completion Date : | November 18, 2022 |

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. |
- 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).
- 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)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
-
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.
- 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.
- Ability to understand and voluntarily sign an informed consent form.
- Age ≥ 18 years at the time of signing the informed consent form.
- Ability to adhere to the study visit schedule and other protocol requirements.
- Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2.
- 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.

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
Germany | |
Diakonie-Klinikum Stuttagrt | |
Stuttgart, Baden-Wuerttemberg, Germany, 70176 | |
Robert-Bosch-Krankenhaus Abteilung fuer Haematologie, Onkologie und Palliativmedizin | |
Stuttgart, Baden-Wuerttemberg, Germany, 70376 | |
University Hospital Tuebingen | |
Tuebingen, Baden-Wuerttemberg, Germany, 72076 | |
Marienhospital | |
Stuttgart, Baden-Württemberg, Germany, 70199 | |
Katharinenhospital | |
Stuttgart, BW, Germany, 70174 |
Responsible Party: | University Hospital Tuebingen |
ClinicalTrials.gov Identifier: | NCT02802943 |
Other Study ID Numbers: |
iVAC-CLL01: |
First Posted: | June 16, 2016 Key Record Dates |
Last Update Posted: | November 28, 2022 |
Last Verified: | November 2022 |
CLL, Peptid Vaccination |
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 Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Interferon Inducers |