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
175 weeks
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
This is a Phase Ib in adult patients with relapsed or refractory EBV-positive DLBCL using daily oral dosing of VK-2019 in three dose escalation cohorts: 600 mg/day, 1200 mg/day, 1800 mg/day for 28 days (cycle), until progression or toxicity.
CONDITIONS
Official 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...
- Provided informed consent before any study assessments
- Age 18 years or older
- Diagnosed with relapsed or refractory EBV-positive Diffuse Large B-cell Lymphoma after at least 2 prior systemic therapies
- Exhausted all available standard treatments that may provide benefit
- Side effects from prior therapies have returned to grade 1 or less, or are stable if chronic; peripheral neuropathy grade 2 or less
- Completed prior anti-cancer treatments more than 2 weeks before starting the study
- Have measurable disease according to IWG 2007 criteria
- ECOG performance status score of 2 or less
- Adequate organ function including neutrophil count above 1,500/microl, hemoglobin above 9 g/dL, platelet count above 75,000/microl, liver enzymes no more than 2.5 times upper normal limit, bilirubin no more than 1.5 times upper normal limit, creatinine clearance 60 ml/min or higher, and urinary protein less than 2+ by dipstick
- Sexually active patients agree to use effective birth control during the study and for 18 weeks after
- Willing and able to follow study visits, treatment plans, lab tests, and other procedures
You will not qualify if you...
- Severe or active heart or lung diseases within the last 12 months, or serious psychiatric disorders
- Metastatic disease with active central nervous system involvement
- Concurrent use of herbal preparations
- Serious uncontrolled medical disorder or active infection that would interfere with study therapy
- Taking drugs that affect OATP1B1 or OATP1B3 transporters within 5 half-lives
- Taking proton pump inhibitors within 5 half-lives
- Prior organ transplant or allogeneic bone marrow transplant with active GVHD or ongoing immunosuppressive drugs
- Current dependence on non-prescription drugs or alcohol
- Pregnancy or breastfeeding for female patients
- Female patients with reproductive potential must have a negative pregnancy test before enrollment
- Other severe medical or psychiatric conditions or lab abnormalities increasing risk or interfering with study
- Corrected QT interval (QTcF) above 470 ms
- Post-Transplant Lymphoproliferative Disease (PTLD)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Honickman Center
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
Research Team
M
Michael S Wysota, MD
CONTACT
A
Ariel Kobylak
CONTACT
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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