Status:
COMPLETED
Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV+ Lymphoid Malignancies
Lead Sponsor:
Viracta Therapeutics, Inc.
Conditions:
Epstein-Barr Virus-Associated Lymphoma
Lymphoproliferative Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
A two part, Phase 1b/2 study to define a recommended Phase 2 dose of VRx-3996 in combination with valganciclovir (Phase 1b) designed to evaluate the efficacy of this combination in relapsed/refractory...
Detailed Description
The purpose of this study is to determine whether VRx-3996 in combination with valganciclovir is safe, determine the side effect profile, and to determine whether this therapy may help patients with E...
Eligibility Criteria
Inclusion
- Key
- Relapsed/refractory, pathologically confirmed Epstein-Barr Virus positive (EBV+) lymphoid malignancy or lymphoproliferative disease
- Absence of available therapy with reasonable likelihood of cure or significant clinical benefit
- Adequate hematologic, hepatic and renal function as defined by laboratory assessment
- Key
Exclusion
- Known primary central nervous system (CNS) lymphoma
- Known CNS metastases or leptomeningeal disease unless appropriately treated and neurologically stable for at least 4 weeks
- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
- Refractory graft versus host disease (GvHD) not responding to treatment
- Known active hepatitis B virus infection
- Circulating hepatitis C virus on quantitative polymerase chain reaction (qPCR)
- Known history of human herpes virus (HHV)-6 chromosomal integration
- Known history of HIV infection
Key Trial Info
Start Date :
March 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2023
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03397706
Start Date
March 29 2018
End Date
May 4 2023
Last Update
March 20 2025
Active Locations (28)
Enter a location and click search to find clinical trials sorted by distance.
1
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
2
University of California, Los Angeles
Los Angeles, California, United States, 90404
3
UC Irvine Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
4
University of Colorado Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045