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

Study Duration and Schedule:

The duration of the trial for each subject is expected to be 24 months. The duration for each individual patient includes about 6 months first-line therapy according to treating physicians choice with HLA ligandome analyses of CLL cells and selection of patient-individual multipeptide vaccine being performed in parallel, 12 months study treatment and 6 months followup time. The overall duration of the trial is expected to be approximately 4 years. Recruitment of subjects will start in 09/2016. The actual overall duration or recruitment may vary.

General Criteria for Subject Selection:

For the screening procedures of this study, physically fit subjects (as defined by ECOG score ≤2) with a confirmed diagnosis of a CLL/SLL according to the IWCLL guidelines requiring treatment are eligible. First line treatment will be performed according to treating physicians choice. The trial population will consist of both genders. Gender distribution in the trial is supposed to reflect the distribution in the real patient's population (approx. 60% male and 40% female patients), i.e. there will be no prior defined quantitative ratio between females and males. To assure that the included patients have the ability to mount an immune response, immune response to an HLA matched EBV/CMV peptide mix will be assessed in the screening phase. 60ml blood will be taken at the screening study visit. Peripheral mononuclear cells will be isolated and analyzed in a 12 day IFNγ ELISPOT for memory Tcell response to an EBV/CMV peptide mix. Only patients showing a positive immune response (section 8.1.1) will be eligible to receive the study drugs after first line treatment.

For the study treatment, physically fit subjects (as defined by ECOG score ≤2) with a confirmed diagnosis of CLL according to the IWCLL guidelines, which were treated with a first line therapy according to physicians choice are eligible. Subjects must have achieved at least a PR (IWCLL guidelines for the diagnosis and treatment of CLL) after treatment with first line therapy.The end of study is determined as the date of the last visit of the last patient (LSO 04/2020).