Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV+ Lymphoid Malignancies
NCT ID: NCT03397706
Last Updated: 2025-03-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
64 participants
INTERVENTIONAL
2018-03-29
2023-05-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
Phase 2: dose expansion
Tablet PK Cohort
TREATMENT
NONE
Study Groups
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Phase 1b Dose Escalation
VRx-3996 (cohort 1) and valganciclovir
VRx-3996 (cohort 2) and valganciclovir
VRx-3996 (cohort 3) and valganciclovir
VRx-3996 (cohort 4) and valganciclovir
VRx-3996 (cohort 5) and valganciclovir
VRx-3996 and valganciclovir
second-generation histone deacetylase (HDAC) inhibitor, nanatinostat (previously referred to as either VRx-3996 or CHR-3396)
Phase 2 Expansion - Capsule
VRx-3996 and valganciclovir at the recommended Phase 2 dose (RP2D)
VRx-3996 and valganciclovir
second-generation histone deacetylase (HDAC) inhibitor, nanatinostat (previously referred to as either VRx-3996 or CHR-3396)
Phase 2 Expansion - Tablet
VRx-3996 and valganciclovir at the recommended Phase 2 dose (RP2D)
VRx-3996 and valganciclovir
second-generation histone deacetylase (HDAC) inhibitor, nanatinostat (previously referred to as either VRx-3996 or CHR-3396)
Interventions
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VRx-3996 and valganciclovir
second-generation histone deacetylase (HDAC) inhibitor, nanatinostat (previously referred to as either VRx-3996 or CHR-3396)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Absence of available therapy with reasonable likelihood of cure or significant clinical benefit
* Adequate hematologic, hepatic and renal function as defined by laboratory assessment
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Viracta Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jill DeFratis Robinson
Role: STUDY_DIRECTOR
Viracta Therapeutics
Locations
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USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of California, Los Angeles
Los Angeles, California, United States
UC Irvine Chao Family Comprehensive Cancer Center
Orange, California, United States
University of Colorado Anschutz Cancer Pavilion
Aurora, Colorado, United States
Mid Florida Hematology and Oncology Center
Orange City, Florida, United States
ASCLEPES Research Centers
Weeki Wachee, Florida, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Ruth M Rothstein CORE Center
Chicago, Illinois, United States
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, United States
The University of Kansas Cancer Center and Medical Pavilion
Westwood, Kansas, United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
St. Vincent Healthcare Cancer Center
Billings, Montana, United States
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Medical College - New York Presbyterian Hospital
New York, New York, United States
The Ohio State University Wexner Medical Center James Cancer Hospital
Columbus, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Texas Oncology - Baylor Sammons Cancer Center
Dallas, Texas, United States
Centro de Hematologia e Oncologia da Bahia (CEHON)
Salvador, Estado de Bahia, Brazil
Hospital de Cancer de Pernambuco (HCP)
Recife, Pernambuco, Brazil
Hospital do Cancer Mae de Deus
Porto Alegre, Rio Grande do Sul, Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia
São Paulo, São Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP)
São Paulo, São Paulo, Brazil
Hospital Santa Marcelina
São Paulo, São Paulo, Brazil
Countries
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References
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Haverkos B, Alpdogan O, Baiocchi R, Brammer JE, Feldman TA, Capra M, Brem EA, Nair S, Scheinberg P, Pereira J, Shune L, Joffe E, Young P, Spruill S, Katkov A, McRae R, Royston I, Faller DV, Rojkjaer L, Porcu P. Targeted therapy with nanatinostat and valganciclovir in recurrent EBV-positive lymphoid malignancies: a phase 1b/2 study. Blood Adv. 2023 Oct 24;7(20):6339-6350. doi: 10.1182/bloodadvances.2023010330.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Viracta Therapeutics, Inc.
Other Identifiers
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VT3996-201
Identifier Type: -
Identifier Source: org_study_id
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