Actively Recruiting
A Phase Ib Study of VK-2019 in Patients With Relapsed or Refractory EBV+ Diffuse Large B-cell Lymphomas (DLBCL)
Led by Thomas Jefferson University · Updated on 2025-10-20
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
Thomas Jefferson University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating VK-2019 in adult patients with relapsed or refractory Epstein-Barr virus (EBV)-positive diffuse large B-cell lymphoma (DLBCL). This Phase Ib, open-label study aims to assess the safety and tolerability of VK-2019 given as a single agent. The trial includes biomarker assessments and follows patients for survival for up to three years. Participants receive daily oral doses of VK-2019 in one of three dose groups: 600 mg, 1200 mg, or 1800 mg. Each treatment cycle lasts 28 days and is repeated until disease progression or unacceptable toxicity occurs. Patients showing stable disease or better after three cycles may continue treatment, while those with progressive disease stop therapy. Dose adjustments may be made if unacceptable toxicity occurs. During the study, patients undergo response assessments every three cycles along with regular monitoring of safety and organ function. Researchers track the maximum tolerated dose and follow all patients for three years to assess survival outcomes. Treatment stops if consent is withdrawn, disease progresses, toxicity is unacceptable, or pregnancy is suspected.
CONDITIONS
Brief Title
A Phase Ib Study of VK-2019 in Patients With Relapsed or Refractory EBV+ Diffuse Large B-cell Lymphomas (DLBCL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Informed consent obtained before any study procedures
- Age 18 years or older
- Diagnosis of relapsed or refractory EBV-positive diffuse large B-cell lymphoma after at least two prior systemic treatment regimens
- Exhaustion of all available standard treatments that could benefit the patient
- Toxicities from prior therapies resolved to Grade 1 or less, or stable if chronic; peripheral neuropathy Grade 2 or less
- Prior anti-cancer treatments completed more than 2 weeks before study start
- Measurable disease as per IWG 2007 criteria
- ECOG performance status score of 2 or less
- Adequate organ function, including specified blood counts and liver/kidney tests
- Agreement to use effective birth control during the study and for 18 weeks after
- Willingness and ability to comply with study visits, treatments, and tests
You will not qualify if you...
- Severe or active heart or lung diseases within the last 12 months or significant psychiatric disorders
- Metastatic disease with active central nervous system involvement
- Concurrent use of herbal supplements
- Serious uncontrolled medical disorders or active infections compromising study participation
- Use of drugs that inhibit or induce OATP1B1/OATP1B3 or proton pump inhibitors within 5 half-lives
- Active graft-versus-host disease or immunosuppressive drug use after prior organ or bone marrow transplant
- Current non-prescription drug or alcohol dependence
- Pregnancy or breastfeeding
- Positive pregnancy test for women of reproductive potential before enrollment
- Other severe acute or chronic medical or psychiatric conditions that increase risk or interfere with study results
- Corrected QT interval (QTcF) greater than 470 ms
- Diagnosis of Post-Transplant Lymphoproliferative Disease (PTLD)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive daily oral doses of VK-2019 in 28-day cycles. Treatment continues until disease progression, unacceptable toxicity, or withdrawal. Response assessments occur every 3 cycles.
Daily dosing with response assessments every 3 cycles
Duration - Up to 3 years
Participants are monitored for survival and safety for up to 3 years after treatment ends.
Periodic visits during follow-up
Trial Site Locations
Total: 1 location
1
Honickman Center
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
Research Team
M
Michael S Wysota, MD
A
Ariel Kobylak
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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