OncoMatch/Clinical Trials/NCT03219450
A Personalized Neoantigen Cancer Vaccine in Treatment Naïve, Asymptomatic Patients With IGHV Unmutated CLL.
Is NCT03219450 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including NeoVax and Cyclophosphamide for lymphocytic leukemia.
Treatment: NeoVax · Cyclophosphamide · Pembrolizumab — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: IGHV unmutated (< 2% mutated compared to germline)
CLL must have an unmutated immunoglobulin heavy chain variable (IGHV) region gene, defined as < 2% mutated compared to germline
Excluded: TP53 deletion
Del(17p) by fluorescence in situ hybridization in ≥ 10% of CLL cells analyzed
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: CLL-directed therapy
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.
Cannot have received: bone marrow or stem cell transplant
Previous bone marrow or stem cell transplant
Cannot have received: anti-PD-1 therapy
Has received prior therapy with an anti-PD1, anti PD-L1, or anti PD-L2 agent.
Lab requirements
Blood counts
absolute neutrophil count ≥1000 cells/μl
Liver function
total bilirubin within normal institutional limits; ast(sgot)/alt(sgpt) ≤2.5 × institutional upper limit of normal
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Dana-Farber Cancer Institute · Boston, Massachusetts
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