Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV-Associated Lymphoid Malignancies



Status:Recruiting
Conditions:Lymphoma, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:1/12/2019
Start Date:March 29, 2018
End Date:August 2019
Contact:Robert McRae, Sr. Director, R&D Operations
Email:ClinicalTrials@Viracta.com
Phone:858-400-8470

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A Phase 1b/2 Open-Label, Dose Escalation & Expansion Study of Orally Administered VRx-3996 & Valganciclovir in Subjects With Epstein-Barr Virus-Associated Lymphoid Malignancies

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 EBV+ lymphomas.

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 EBV-related lymphomas. The study has two phases. Goals of the first phase
include determining a safe and tolerable dose that can be administered in phase 2. Goals of
the second phase include further evaluating the safety and tolerability of VRx-3996 in
combination with valganciclovir, evaluating how the drugs are metabolized in the body,
evaluating response rates and other exploratory objectives that will help the researchers
evaluate how these drugs work in the body. Participants will receive daily oral doses of the
two study drugs and will have multiple study visits where they will have blood collected,
physical examinations, and other medical monitoring.

Key Inclusion Criteria:

- Relapsed/refractory, pathologically confirmed 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 Criteria:

- Known primary 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 qPCR
We found this trial at
17
sites
2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: Vijayalakshmi Donthireddy, MD
Phone: 313-916-7827
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Baltimore, Maryland 21231
410-955-6190
Principal Investigator: Richard Ambinder, MD
Phone: 410-502-5396
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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Baltimore, MD
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Augusta, Georgia 30912
Principal Investigator: Locke Bryan, MD
Phone: 706-721-0660
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Aurora, Colorado 80045
Principal Investigator: Bradley Haverkos, MD
Phone: 720-848-0736
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Chicago, Illinois 60612
Principal Investigator: Paul Rubenstein, MD
Phone: 312-572-4543
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Principal Investigator: Reem Karmali, MD, MS
Phone: 312-695-0990
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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Chicago, IL
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Columbus, Ohio 43210
Principal Investigator: Jonathon Brammer, MD
Phone: 614-366-0855
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Hackensack, New Jersey 07601
Principal Investigator: Tatyana Feldman, MD
Phone: 551-996-5952
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Indianapolis, Indiana 46237
Principal Investigator: John Edwards, MD
Phone: 317-528-7298
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
Principal Investigator: Anil Tulpule, MD
Phone: 323-865-0371
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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New York, New York 10021
Principal Investigator: Koen van Besien, MD, PhD
Phone: 212-746-2844
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Ahmed Sawas, MD
Phone: 212-326-5720
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Orange, California 92868
Principal Investigator: Elizabeth Brem, MD
Phone: 714-509-2414
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Philadelphia, Pennsylvania 19111
Principal Investigator: Carlyn Tan, MD
Phone: 215-214-3173
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Onder Alpdogan, MD
Phone: 215-955-2810
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Salvador, BA 40110
Principal Investigator: Ana Luzia Schriefer, MD
Phone: +55 (71) 3281-6484
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Westwood, Kansas 66205
Principal Investigator: Anusha Vallurupalli, MD
Phone: 913-588-2545
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