RecruitingLymphocytic Leukemia
A Personalized Neoantigen Cancer Vaccine in Treatment Naïve, Asymptomatic Patients With IGHV Unmutated CLL.
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
This research study is studying a novel type of CLL vaccine as a possible treatment for chronic lymphocytic leukemia (CLL) The names of the study interventions involved in this study are: * Personalized NeoAntigen Vaccine * Poly-ICLC * Cyclophosphamide * Pembrolizumab
Sponsor: Dana-Farber Cancer Institute
You may qualify if…
- ✓ Diagnosis of CLL as per IWCLL 2018 criteria
- ✓ Patient's CLL must have an unmutated immunoglobulin heavy chain variable (IGHV) region gene, defined as \< 2% mutated compared to germline.
- ✓ Patient must have had no history of CLL-directed therapy due to meeting IWCLL 2018 criteria; no present indication for treatment by iwCLL 2018 criteria; and in the opinion of the treating investigator be anticipated not to require CLL-directed treatment within the next 6 months.
- ✓ Patient must have measurable disease (absolute lymphocyte count \> 10K/uL or total white blood cell count ≥ 20K/uL of peripheral blood).
- ✓ Patient must have had at least two other absolute lymphocyte counts (ALC) measured since diagnosis of CLL that are at least 2 weeks apart and at least 2 months prior to the one used for initial registration.
- ✓ Age ≥ 18 years.
- ✓ ECOG performance status 0 or 1
- ✓ Participants must have normal organ and marrow function as defined below:
You may not qualify if…
- ✕ Prior therapy for CLL that met IW-CLL treatment criteria, including chemotherapy, targeted therapies (e.g. that antagonize B cell receptor signaling), or immunotherapy (including but not limited to monoclonal antibodies); or radiotherapy or hormonal therapy within the last 2 years of screening registration.
- ✕ Participants who are receiving any other investigational agents.
- ✕ Previous bone marrow or stem cell transplant
- ✕ Concomitant therapy with immunosuppressive or immunomodulatory agents; chronic use of systemic corticosteroids. Previous history of corticosteroid use is acceptable. Use of corticosteroids after initial registration is acceptable if tapered at least one week before NeoVax administration.
- ✕ Use of a non-oncology vaccine therapy for prevention of infectious diseases within 2 weeks of any NeoVax administration.
- ✕ History of severe allergic reactions attributed to any vaccine therapy for the prevention of infectious diseases.
- ✕ Participants who have never received the tetanus vaccine.
- ✕ Active, known, or suspected autoimmune disease or immunosuppressive conditions with the exception of vitiligo, type 1 diabetes, residual autoimmune-related hypothyroidism requiring hormone replacement, or psoriasis not requiring systemic treatment.
Where it's recruiting
Massachusetts
Boston
Source: ClinicalTrials.gov · NCT03219450 · last updated 2026-05-28