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New treatment option for Diffuse Large B Cell Lymphoma Refractory
Official title A Phase Ib Study of VK-2019 in Patients With Relapsed or Refractory EBV+ Diffuse Large B-cell Lymphomas (DLBCL)
ClinicalTrials.gov ID: NCT06789159
What this study is testing
What is VK-2019?
VK-2019 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for diffuse large b cell lymphoma refractory.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 4.1 1. Informed consent obtained prior to any protocol mandated assessment.
- Age ≥ 18 years.
- Patient must have relapsed or refractory EBV-positive DLBCL after a minimum of 2 prior regimens of systemic therapy.
- Patient must have exhausted all available standard of care treatment options that could potentially provide clinical benefit.
- Toxicities related to prior therapy must have returned to Grade 1 or less, or if chronic must be stable. Peripheral neuropathy must be Grade 2 or less
You likely can't join if
- Patients with severe or active symptomatic cardiopulmonary diseases (unstable angina and/or congestive heart failure or peripheral vascular disease...
- Patients with metastatic disease with active central nervous system (CNS) involvement, defined as parenchymal brain or leptomeningeal involvement.
- Concurrent administration of herbal preparations.
- A serious uncontrolled medical disorder or active infection which would impair the ability of the subject to receive protocol therapy or whose...
- Patients currently taking drugs that inhibit or induce OATP1B1 or OATP1B3 within 5 half- lives of that agent. Examples are included in Appendix B.
- Patients currently taking drugs that are proton pump inhibitors (PPIs) within 5 half- lives of that agent. Examples are included in Appendix B.
See the full eligibility criteria
- 4.1 1. Informed consent obtained prior to any protocol mandated assessment.
- Age ≥ 18 years.
- Patient must have relapsed or refractory EBV-positive DLBCL after a minimum of 2 prior regimens of systemic therapy.
- Patient must have exhausted all available standard of care treatment options that could potentially provide clinical benefit.
- Toxicities related to prior therapy must have returned to Grade 1 or less, or if chronic must be stable. Peripheral neuropathy must be Grade 2 or less
- Prior anti-cancer treatment must have been completed greater than 2 weeks prior to study day 1.
- Patients must have measurable disease, as defined by IWG 2007 criteria.
- ECOG performance status score of ≤2
- Adequate organ function as defined by the following criteria:
- Absolute neutrophil count \> 1,500/microl (stable off any growth factor within 1 week of study drug administration)
- Hemoglobin \> 9 g/dL (transfusion to achieve this level is permitted)
- Platelet count \> 75,000/microl (transfusion to achieve this level is NOT permitted)
- Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN);
- Total serum bilirubin ≤ 1.5 x ULN;
- Creatinine clearance≥ 60 ml/min as calculated per Cockcroft and Gault equation.
- Urinary protein \< 2+ by dipstick. If dipstick ≥ 2+, then a 24-hour urine collection can be done, and the patient may enter only if urinary protein is \< 1 g/24 hour;
- Sexually active patients will agree to utilize birth control method during the study and for 18 weeks after the study is concluded, using effective birth control methods as defined in...
- Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures. 4.2
- Patients with severe or active symptomatic cardiopulmonary diseases (unstable angina and/or congestive heart failure or peripheral vascular disease within the last 12 months; chronic obstructive pulmonary disease...
- Patients with metastatic disease with active central nervous system (CNS) involvement, defined as parenchymal brain or leptomeningeal involvement.
- Concurrent administration of herbal preparations.
- A serious uncontrolled medical disorder or active infection which would impair the ability of the subject to receive protocol therapy or whose control may be jeopardized by the complications of this therapy.
- Patients currently taking drugs that inhibit or induce OATP1B1 or OATP1B3 within 5 half- lives of that agent. Examples are included in Appendix B.
- Patients currently taking drugs that are proton pump inhibitors (PPIs) within 5 half- lives of that agent. Examples are included in Appendix B.
- Patients who have received a prior organ allograft or allogeneic bone marrow transplant are eligible but must have no evidence of active GVHD and be off immunosuppressive drugs.
- Current non-prescription drug or alcohol dependence;
- For all female patients, pregnancy or breastfeeding.
- All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the...
- Patients with corrected QT by Fridericia's formula (QTcF) of \>470 ms are excluded.
- Patients with Post-Transplant Lymphoproliferative Disease (PTLD) are excluded.
The study team makes the final eligibility decision.
Where it's taking place
- Lexington, Kentucky, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lexington, Kentucky, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.