OncoMatch

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.

Phase 1RecruitingDana-Farber Cancer InstituteNCT03219450Data as of May 2026

Treatment: NeoVax · Cyclophosphamide · PembrolizumabThis 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 qualify

Extracted 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

No prior treatment (treatment-naive required)
Max 0 prior lines
Min 0 prior lines

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 →

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 qualify