OncoMatch/Clinical Trials/NCT03219450
A Personalized Neoantigen Cancer Vaccine in Treatment Naïve, Asymptomatic Patients With IGHV Unmutated CLL.
Is NCT03219450 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
Chemotherapy
Other
Cancer type
Chronic Lymphocytic 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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT03219450 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require IGHV?
Yes, IGHV unmutated is a required biomarker for enrollment.
Are patients with TP53 alterations eligible?
No. TP53 deletion is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages