Trial · NCT03397706
Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV+ Lymphoid Malignancies
NCT03397706, Phase 1, Phase 2, Completed, Viracta Therapeutics, Inc.; results first posted 2025-03-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV+ Lymphoid Malignancies. Trials, record NCT03397706. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03397706
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV+ Lymphoid Malignancies
- NCT number
- NCT03397706
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 64 participants, actual
- Lead sponsor
- Viracta Therapeutics, Inc.
- Conditions
- Epstein-Barr Virus-Associated Lymphoma, Lymphoproliferative Disorders
- Interventions
- VRx-3996 and valganciclovir
- First posted
- 2018-01-12
- Last updated
- 2025-03-20
- Results first posted
- 2025-03-20
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number (Proportion) of Participants With Adverse Events (AEs) | Up to approximately 2 years | Number (percentage) of patients experiencing at least one treatment-emergent adverse event, defined as those untoward medical events with onset after the first dose of study drug or existing events that worsened after the first dose during the study |
| Primary | Number (Proportion) of Participants With Dose-Limiting Toxicities (DLTs) in Phase 1b | Cycle 1 (28 days) | Number (percentage) of patients experiencing a DLT during the first cycle (28 days) of study treatment in Phase 1b, defined as an adverse event (AE) or clinically significant abnormal laboratory value that was at least possibly related to study drugs and was not primarily related to disease, disease progression, concomitant medication(s), or intercurrent illness. In addition, to be considered a DLT, the AE had to meet at least one of the following criteria: * Grade 4 anemia unexplained by underlying disease * Grade 4 febrile neutropenia * Grade 4 neutropenia lasting \>5 days * Any other Grade 4 hematologic toxicity (thrombocytopenia, neutropenia, febrile neutropenia, anemia) of any duration * Grade 4 or higher tumor lysis syndrome * Grade 3 or higher thrombocytopenia (with or without bleeding) * Any requirement for platelet transfusion * Grade 3 or higher non-hematologic toxicity despite adequate supportive care * Results in a dose hold of \>7 consecutive days |
| Primary | Overall Response Rate | Up to approximately 2 years | Number (percentage) of patients with a best overall complete response (CR) or partial response (PR) according to the Lugano 2014 criteria (Cheson, Bruce D. et al. J Clin Oncology 2014;32(27):3059-68), where CR included complete metabolic response (no/minimal fluorodeoxyglucose \[FDG\] uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions, and PR included partial metabolic response (reduced FDG uptake compared with baseline) or radiologic response (target lesions ≤ 50% decrease in the sum of the product of perpendicular diameters of up to 6 target measurable nodes and extranodal sites) |
| Secondary | Duration of Response | Up to approximately 2 years | Interval of time from date of first observed complete or partial response per Lugano 2014 criteria (Cheson BD et al. J Clin Oncology 2014;32(27):3059-68) to the date of documented disease progression or death due to any cause, where disease progression is defined by Lugano 2014 criteria (Cheson BD et al. J Clin Oncology 2014;32(27):3059-68) as progressive metabolic disease (increase in fluorodeoxyglucose \[FDG\] uptake from baseline or new FDG-avid foci consistent with lymphoma) or progressive radiologic response (increase in the product of perpendicular diameters of a single node by ≥ 50% or emergence of a new lesion) |
| Secondary | Time to Response | Up to approximately 2 years | Interval of time from the start of study drug treatment to the first documentation of CR or PR per Lugano 2014 criteria (Cheson BD et al. J Clin Oncology 2014;32(27):3059-68) |
| Secondary | Progression-Free Survival | Up to approximately 2 years | Interval of time from the date of first study drug administration to the documented date of disease progression or death, whichever occurred first, where disease progression is defined by Lugano 2014 criteria (Cheson BD et al. J Clin Oncology 2014;32(27):3059-68) as progressive metabolic disease (increase in fluorodeoxyglucose \[FDG\] uptake from baseline or new FDG-avid foci consistent with lymphoma) or progressive radiologic response (increase in the product of perpendicular diameters of a single node by ≥ 50% or emergence of a new lesion) |
| Secondary | Disease Control Rate | Up to approximately 2 years | Number (percentage) of patients with CR, PR, or stable disease (SD) per Lugano 2014 criteria (Cheson BD et al. J Clin Oncology 2014;32(27):3059-68) |
| Secondary | Overall Survival | Up to approximately 2 years | Interval of time from date of first study drug treatment to date of death, for any reason (patients without documentation of death at the time of analysis were censored at the date the patient was last known to be alive) |
| Secondary | Cmax (ng/mL) of VRx-3996 | Phase 1b: Cycle 1 Day 1 and Phase 2: multiple doses through Cycle 2 Day 1 | Pharmacokinetic (PK) assessment of VRx-3996 pre-dose and at hours 0.5, 1, 2, 4, and 6 post-dose on cycle 1 day 1 (C1D1) and cycle 2 day 2 (C2D1) |
| Secondary | Cmax (ng/mL) of Valganciclovir | Phase 1b: Cycle 1 Day 1 and Phase 2: multiple doses through Cycle 2 Day 1 | PK assessment of valganciclovir pre-dose and at hours 0.5, 1, 2, 4, and 6 post-dose on C1D1 and C2D1 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number (Proportion) of Participants With Adverse Events (AEs) | Up to approximately 2 years | Safety Analysis Set, defined as all enrolled patients who received at least 1 dose of study treatment. Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number (Proportion) of Participants With Dose-Limiting Toxicities (DLTs) in Phase 1b | Cycle 1 (28 days) | Safety Analysis Set, defined as all enrolled patients who received at least 1 dose of study treatment. Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Overall Response Rate | Up to approximately 2 years | Efficacy Evaluable Analysis Set, defined as all patients with measurable/evaluable disease at screening who met all eligibility criteria and had at least one evaluable post-baseline efficacy tumor assessment. Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response | Up to approximately 2 years | Patients who achieved a CR or PR. Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment. | days | MEDIAN |
| SECONDARY | Time to Response | Up to approximately 2 years | Patients who achieved a PR or CR. Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment. | days | MEDIAN |
| SECONDARY | Progression-Free Survival | Up to approximately 2 years | Efficacy Evaluable Analysis Set, defined as all patients with measurable/evaluable disease at screening who met all eligibility criteria and had at least one evaluable post-baseline efficacy tumor assessment. Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment. | days | MEDIAN |
| SECONDARY | Disease Control Rate | Up to approximately 2 years | Efficacy Evaluable Analysis Set, defined as all patients with measurable/evaluable disease at screening who met all eligibility criteria and had at least one evaluable post-baseline efficacy tumor assessment. Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | Up to approximately 2 years | Efficacy Evaluable Analysis Set, defined as all patients with measurable/evaluable disease at screening who met all eligibility criteria and had at least one evaluable post-baseline efficacy tumor assessment. Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment. | days | MEDIAN |
| SECONDARY | Cmax (ng/mL) of VRx-3996 | Phase 1b: Cycle 1 Day 1 and Phase 2: multiple doses through Cycle 2 Day 1 | The PK Analysis Set was used for all PK analyses and included all patients in the intent-to-treat population (defined as all enrolled patients) who had at least one postdose measurable PK concentration. The PK Analysis Set will be used for individual plasma concentration listings and summaries of plasma concentrations. | ng/mL | MEAN |
| SECONDARY | Cmax (ng/mL) of Valganciclovir | Phase 1b: Cycle 1 Day 1 and Phase 2: multiple doses through Cycle 2 Day 1 | The PK Analysis Set was used for all PK analyses and included all patients in the intent-to-treat population (defined as all enrolled patients) who had at least one postdose measurable PK concentration. The PK Analysis Set will be used for individual plasma concentration listings and summaries of plasma concentrations. | ng/mL | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group111
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number (Proportion) of Participants With Adverse Events (AEs) | Phase 1b Dose Escalation Cohort 1 | 7 | Participants | ||
| Number (Proportion) of Participants With Adverse Events (AEs) | Phase 1b Dose Escalation Cohort 2a | 5 | Participants | ||
| Number (Proportion) of Participants With Adverse Events (AEs) | Phase 1b Dose Escalation Cohort 2b | 4 | Participants | ||
| Number (Proportion) of Participants With Adverse Events (AEs) | Phase 1b Dose Escalation Cohort 2c | 4 | Participants | ||
| Number (Proportion) of Participants With Adverse Events (AEs) | Phase 1b Dose Escalation Cohort 3 | 5 | Participants | ||
| Number (Proportion) of Participants With Adverse Events (AEs) | Phase 2 Dose Expansion - Capsule | 30 | Participants | ||
| Number (Proportion) of Participants With Adverse Events (AEs) | Phase 2 Dose Expansion - Tablet | 9 | Participants | ||
| Number (Proportion) of Participants With Dose-Limiting Toxicities (DLTs) in Phase 1b | Phase 1b Dose Escalation Cohort 1 | 4 | Participants | ||
| Number (Proportion) of Participants With Dose-Limiting Toxicities (DLTs) in Phase 1b | Phase 1b Dose Escalation Cohort 2a | 0 | Participants | ||
| Number (Proportion) of Participants With Dose-Limiting Toxicities (DLTs) in Phase 1b | Phase 1b Dose Escalation Cohort 2b | 0 | Participants |
1 to 10 of 111Source ClinicalTrials.gov
See all 111 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1b Dose Escalation Cohort 1 | 7 | |
| Overall Study | STARTED | Phase 1b Dose Escalation Cohort 2a | 5 | |
| Overall Study | STARTED | Phase 1b Dose Escalation Cohort 2b | 4 | |
| Overall Study | STARTED | Phase 1b Dose Escalation Cohort 2c | 4 | |
| Overall Study | STARTED | Phase 1b Dose Escalation Cohort 3 | 5 | |
| Overall Study | STARTED | Phase 2 Dose Expansion - Capsule | 30 | |
| Overall Study | STARTED | Phase 2 Expansion - Tablet | 9 | |
| Overall Study | COMPLETED | Phase 1b Dose Escalation Cohort 1 | 7 | |
| Overall Study | COMPLETED | Phase 1b Dose Escalation Cohort 2a | 5 | |
| Overall Study | COMPLETED | Phase 1b Dose Escalation Cohort 2b | 4 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events567
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Thrombocytopenia | Gastrointestinal disorders | Phase 1b Dose Escalation Cohort 1 | 2 | 7 | |
| other | Thrombocytopenia | Gastrointestinal disorders | Phase 1b Dose Escalation Cohort 2a | 2 | 5 | |
| other | Thrombocytopenia | Gastrointestinal disorders | Phase 1b Dose Escalation Cohort 2b | 0 | 4 | |
| other | Thrombocytopenia | Gastrointestinal disorders | Phase 1b Dose Escalation Cohort 2c | 2 | 4 | |
| other | Thrombocytopenia | Gastrointestinal disorders | Phase 1b Dose Escalation Cohort 3 | 0 | 5 | |
| other | Thrombocytopenia | Gastrointestinal disorders | Phase 2 Dose Expansion - Capsule | 5 | 30 | |
| other | Thrombocytopenia | Gastrointestinal disorders | Phase 2 Dose Expansion - Tablet | 0 | 9 | |
| other | Constipation | Gastrointestinal disorders | Phase 1b Dose Escalation Cohort 1 | 1 | 7 | |
| other | Constipation | Gastrointestinal disorders | Phase 1b Dose Escalation Cohort 2a | 4 | 5 | |
| other | Constipation | Gastrointestinal disorders | Phase 1b Dose Escalation Cohort 2b | 0 | 4 |
1 to 10 of 567Source ClinicalTrials.gov
See all 567 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1b Dose Escalation Cohort 1 | 4 | 7 |
| Total, all-cause mortality | Phase 1b Dose Escalation Cohort 2a | 4 | 5 |
| Total, all-cause mortality | Phase 1b Dose Escalation Cohort 2b | 2 | 4 |
| Total, all-cause mortality | Phase 1b Dose Escalation Cohort 2c | 4 | 4 |
| Total, all-cause mortality | Phase 1b Dose Escalation Cohort 3 | 3 | 5 |
| Total, all-cause mortality | Phase 2 Dose Expansion - Capsule | 17 | 30 |
| Total, all-cause mortality | Phase 2 Dose Expansion - Tablet | 4 | 9 |
| Total, other adverse events | Phase 1b Dose Escalation Cohort 1 | 7 | 7 |
| Total, other adverse events | Phase 1b Dose Escalation Cohort 2a | 5 | 5 |
| Total, other adverse events | Phase 1b Dose Escalation Cohort 2b | 4 | 4 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37530631 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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