iVAC-CLL01: Patient-individualized peptide vaccination after first line therapy of C

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Not specified

Target Recruitment: 56

Inclusion 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 IFN? 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 56
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. High risk CLL/SLL
• 17p-deletion or
• TP53 mutation
2. Pregnant or lactating females.
3. Participation in any clinical study or having taken any
investigational therapy, which would interfere with the studys
primary end point.
4. Patients who have received any other vaccine within 1
month prior to study inclusion.
5. Prior history of malignancies, other than CLL, unless the
subject has been free of the disease for = 5 years. Exceptions
include the following:
• Basal cell carcinoma of the skin
• Carcinoma in situ of the cervix
• Carcinoma in situ of the breast
• Incidental histological finding of prostate cancer (TNM
stage of T1a or T1b)
6. Any of the following laboratory abnormalities:
For Vaccination phase:
7. Disease transformation (active) (i.e. Richter’s Syndrome,
prolymphocytic leukemia).
8. Any immunosupressive treatment except corticosteroids.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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