Trial · NCT05011058
An Open-Label Phase 2 Trial of Nanatinostat Plus Valganciclovir in Patients With EBV+ Relapsed/Refractory Lymphomas
NCT05011058, Phase 2, Terminated, Viracta Therapeutics, Inc.; results first posted 2025-07-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Open-Label Phase 2 Trial of Nanatinostat Plus Valganciclovir in Patients With EBV+ Relapsed/Refractory Lymphomas. Trials, record NCT05011058. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05011058
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-Label Phase 2 Trial of Nanatinostat Plus Valganciclovir in Patients With EBV+ Relapsed/Refractory Lymphomas
- NCT number
- NCT05011058
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 102 participants, actual
- Lead sponsor
- Viracta Therapeutics, Inc.
- Conditions
Epstein-Barr Virus Associated Lymphoma, EBV-Positive DLBCL, NOS, EBV-Related Non-Hodgkin Lymphoma, EBV Related PTCL, NOS, EBV-Related Hodgkin Lymphoma, EBV-Related PTLD, EBV-Related Lymphoproliferative Disorder
- Interventions
- Nanatinostat in combination with valganciclovir
- First posted
- 2021-08-18
- Last updated
- 2025-07-28
- Results first posted
- 2025-07-28
- Limitations and caveats
- The study was terminated prematurely.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | Up to approximately 2 years | Number (percentage) of patients with a best overall complete response (CR) or partial response (PR) according to the 2007 International Working Group (IWG) criteria, where CR included complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy with all lymph nodes and nodal masses having regressed on computed tomography to normal size, and PR included at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, no increase should have been observed in the size of other nodes, liver, or spleen, and splenic and hepatic nodules must have regressed by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter. |
| Secondary | Duration of Response (DOR) | Up to approximately 2 years | Interval of time from date of first observed complete or partial response per 2007 International Working Group (IWG) criteria to the date of documented disease progression or death due to any cause, where disease progression is defined by 2007 IWG criteria as any new lesion or increase by ≥ 50% of previously involved sites from nadir. DOR was censored at the time of study withdrawal for hematopoietic stem cell transplant, or at the time of study termination, whichever was earlier, for patients whose disease was still in response. |
| Secondary | Time to Next Anti-Lymphoma Treatment (TTNLT) | Up to approximately 3 years | Interval of time from the start of study drug treatment to the date of next anti-lymphoma treatment (including chemotherapy, radiotherapy, radioimmunotherapy, or immunotherapy). |
| Secondary | Time to Progression (TTP) | Up to approximately 3 years | Interval of time from the start of study drug treatment to the date of disease progression, where disease progression is defined by 2007 IWG criteria as any new lesion or increase by ≥ 50% of previously involved sites from nadir. TTP was censored at the time of study withdrawal for hematopoietic stem cell transplant, at the time of study treatment withdrawal (or at the time of crossover from monotherapy to combination therapy), or at the time of study termination, whichever was earliest, for patients without reported disease progression. |
| Secondary | Progression-Free Survival (PFS) | Up to approximately 3 years | Interval of time from the start of study drug treatment to the date of first documented disease progression (defined by 2007 IWG criteria as any new lesion or increase by ≥ 50% of previously involved sites from nadir), initiation of new antineoplastic therapy, or death from any cause, whichever occurred first. PFS was censored at the time of study withdrawal for hematopoietic stem cell transplant, at the time of study treatment withdrawal (or at the time of crossover from monotherapy to combination therapy), or at the time of study termination, whichever was earliest, for patients without reported disease progression or death. |
| Secondary | Overall Survival (OS) | Up to approximately 3 years | Interval of time from the start of study drug treatment to the date of death for any reason. OS was censored at the time of study withdrawal or study termination, whichever was earlier, for patients without reported death. |
| Secondary | Number (Percentage) 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 |
| Secondary | Pharmacokinetic (PK) Parameter - Time to Maximum Plasma Concentration [Tmax] | Cycle 1 Day 1 and Cycle 6 Day 1 at pre-dose and 1, 2, 4, and 6 hours post-dose (each cycle was 28 days) | Defined as the time required to reach peak plasma concentration \[Cmax\] after study drug administration |
| Secondary | Pharmacokinetic (PK) Parameter - Maximum Plasma Concentration [Cmax] | Cycle 1 Day 1 and Cycle 6 Day 1 at pre-dose and 1, 2, 4, and 6 hours post-dose (each cycle was 28 days) | Defined as the peak plasma concentration \[Cmax\] after study drug administration |
| Secondary | Pharmacokinetic Parameter - Area Under the Plasma Concentration-Time Curve [AUC0-t] | Cycle 1 Day 1 and Cycle 6 Day 1 at pre-dose and 1, 2, 4, and 6 hours post-dose (each cycle was 28 days) | Defined as the area under the concentration-time curve from time 0 to the last measurable plasma concentration |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) | Up to approximately 2 years | Intent-to-Treat Analysis Set, defined as all patients who were enrolled into the trial regardless of whether or not they received study treatment.~The study was not designed to make formal statistical comparisons of ORRs between cohorts. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DOR) | Up to approximately 2 years | Patients who achieved a CR or PR. The study was not designed to make formal statistical comparisons of DOR between cohorts. | days | MEDIAN |
| SECONDARY | Time to Next Anti-Lymphoma Treatment (TTNLT) | Up to approximately 3 years | The clinical trial was terminated before the outcome measure data were collected (data export from the clinical database just prior to study termination retrieved from data manager files contained data listings to support determinations of other secondary efficacy outcome measures but not post-treatment anticancer therapy regimen dates to support TTNLT determination, and investigation into the cause of these uncollected data was preempted by sponsor company closure soon after study termination). | ||
| SECONDARY | Time to Progression (TTP) | Up to approximately 3 years | Intent-to-Treat Analysis Set, defined as all patients who were enrolled into the trial regardless of whether or not they received study treatment.~The study was not designed to make formal statistical comparisons of TTP between cohorts. | days | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) | Up to approximately 3 years | Intent-to-Treat Analysis Set, defined as all patients who were enrolled into the trial regardless of whether or not they received study treatment.~The study was not designed to make formal statistical comparisons of PFS between cohorts. | days | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to approximately 3 years | Intent-to-Treat Analysis Set, defined as all patients who were enrolled into the trial regardless of whether or not they received study treatment.~The study was not designed to make formal statistical comparisons of OS between cohorts. | days | MEDIAN |
| SECONDARY | Number (Percentage) 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.~The study was not designed to make formal statistical comparisons of AE numbers (percentages) between cohorts. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmacokinetic (PK) Parameter - Time to Maximum Plasma Concentration [Tmax] | Cycle 1 Day 1 and Cycle 6 Day 1 at pre-dose and 1, 2, 4, and 6 hours post-dose (each cycle was 28 days) | Defined as all patients (pts) who received at least 1 dose of study drug on Cycle 1 Day 1 and had at least 1 valid PK concentration. Tmax data were previously generated for subset of 50 pts, 4 of whom reached Cycle 6 at time of analysis. As prespecified by the analysis plan, combination therapy cohorts were combined since Tmax for small molecules should not be affected by lymphoma subtype. PK samples from remaining pts were not tested due to sponsor company closure soon after study termination. | hours | MEDIAN |
| SECONDARY | Pharmacokinetic (PK) Parameter - Maximum Plasma Concentration [Cmax] | Cycle 1 Day 1 and Cycle 6 Day 1 at pre-dose and 1, 2, 4, and 6 hours post-dose (each cycle was 28 days) | Defined as all patients (pts) who received at least 1 dose of study drug on Cycle 1 Day 1 and had at least 1 valid PK concentration. Cmax data were previously generated for subset of 50 pts, 4 of whom reached Cycle 6 at time of analysis. As prespecified by the analysis plan, combination therapy cohorts were combined since Cmax for small molecules should not be affected by lymphoma subtype. PK samples from remaining pts were not tested due to sponsor company closure soon after study termination. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetic Parameter - Area Under the Plasma Concentration-Time Curve [AUC0-t] | Cycle 1 Day 1 and Cycle 6 Day 1 at pre-dose and 1, 2, 4, and 6 hours post-dose (each cycle was 28 days) | Defined as all patients (pts) who received at least 1 dose of study drug on Cycle 1 Day 1 and had at least 1 valid PK concentration. AUC0-t data were previously generated for subset of 50 pts, 4 of whom reached Cycle 6 at time of analysis. As prespecified by the analysis plan, combination therapy cohorts were combined since AUC for small molecules should not be affected by lymphoma subtype. PK samples from remaining pts were not tested due to sponsor company closure soon after study termination. | ng*h/mL | GEOMETRIC_MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group95
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | Diffuse Large B-Cell Lymphoma | 0 | Participants | ||
| Objective Response Rate (ORR) | Extranodal Natural Killer/T-Cell Lymphoma | 0 | Participants | ||
| Objective Response Rate (ORR) | Peripheral T-Cell Lymphoma (Combination Therapy) | 11 | Participants | ||
| Objective Response Rate (ORR) | Peripheral T-Cell Lymphoma (Monotherapy) | 1 | Participants | ||
| Objective Response Rate (ORR) | Hodgkin Lymphoma | 0 | Participants | ||
| Objective Response Rate (ORR) | Post-Transplant Lymphoproliferative Disorders | 0 | Participants | ||
| Objective Response Rate (ORR) | Human Immunodeficiency Virus-Associated Lymphomas | 0 | Participants | ||
| Objective Response Rate (ORR) | Other EBV-Positive Lymphomas | 2 | Participants | ||
| Duration of Response (DOR) | Peripheral T-Cell Lymphoma (Combination Therapy) | 98 | Full Range 29 to 340 | days | |
| Duration of Response (DOR) | Peripheral T-Cell Lymphoma (Monotherapy) | 43 | Full Range 43 to 43 | days |
1 to 10 of 95Source ClinicalTrials.gov
See all 95 results by groupParticipant flow56
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Diffuse Large B-Cell Lymphoma | 9 | |
| Overall Study | STARTED | Extranodal Natural Killer/T-Cell Lymphoma | 11 | |
| Overall Study | STARTED | Peripheral T-Cell Lymphoma (Combination Therapy) | 38 | |
| Overall Study | STARTED | Peripheral T-Cell Lymphoma (Monotherapy) | 10 | |
| Overall Study | STARTED | Hodgkin Lymphoma | 8 | |
| Overall Study | STARTED | Post-Transplant Lymphoproliferative Disorders | 3 | |
| Overall Study | STARTED | Human Immunodeficiency Virus-Associated Lymphomas | 3 | |
| Overall Study | STARTED | Other EBV-Positive Lymphomas | 20 | |
| Overall Study | Stage 1 | Diffuse Large B-Cell Lymphoma | 9 | |
| Overall Study | Stage 1 | Extranodal Natural Killer/T-Cell Lymphoma | 11 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 participant flowAdverse events756
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 | Anaemia | Blood and lymphatic system disorders | Diffuse Large B-Cell Lymphoma | 2 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | Extranodal Natural Killer/T-Cell Lymphoma | 4 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | Peripheral T-Cell Lymphoma (Combination Therapy) | 7 | 38 | |
| other | Anaemia | Blood and lymphatic system disorders | Peripheral T-Cell Lymphoma (Monotherapy) | 5 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Peripheral T-Cell Lymphoma (Crossover) | 3 | 5 | |
| other | Anaemia | Blood and lymphatic system disorders | Hodgkin Lymphoma | 4 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | Post-Transplant Lymphoproliferative Disorders | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Human Immunodeficiency Virus-Associated Lymphomas | 2 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Other EBV-Positive Lymphomas | 7 | 20 | |
| other | Nausea | Gastrointestinal disorders | Diffuse Large B-Cell Lymphoma | 1 | 9 |
1 to 10 of 756Source ClinicalTrials.gov
See all 756 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Diffuse Large B-Cell Lymphoma | 3 | 9 |
| Total, all-cause mortality | Extranodal Natural Killer/T-Cell Lymphoma | 9 | 11 |
| Total, all-cause mortality | Peripheral T-Cell Lymphoma (Combination Therapy) | 9 | 38 |
| Total, all-cause mortality | Peripheral T-Cell Lymphoma (Monotherapy) | 4 | 10 |
| Total, all-cause mortality | Peripheral T-Cell Lymphoma (Crossover) | 2 | 5 |
| Total, all-cause mortality | Hodgkin Lymphoma | 3 | 8 |
| Total, all-cause mortality | Post-Transplant Lymphoproliferative Disorders | 1 | 3 |
| Total, all-cause mortality | Human Immunodeficiency Virus-Associated Lymphomas | 1 | 3 |
| Total, all-cause mortality | Other EBV-Positive Lymphomas | 8 | 20 |
| Total, other adverse events | Diffuse Large B-Cell Lymphoma | 9 | 9 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05011058
GET https://conductscience.org/api/trials/v1/NCT05011058/results?page=2