TriangleNCT05011058 · REGISTRY CONDITION SEARCH
An Open-Label Phase 2 Trial of Nanatinostat Plus Valganciclovir in Patients With EBV+ Relapsed/Refractory Lymphomas
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE2
- Status at capture
- TERMINATED
- Registry last update
- 2025-07-28
A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Objective Response Rate (ORR)
Duration of Response (DOR)
Time to Next Anti-Lymphoma Treatment (TTNLT)
Time to Progression (TTP)
Progression-Free Survival (PFS)
Overall Survival (OS)
Number (Percentage) of Participants With Adverse Events (AEs)
Pharmacokinetic (PK) Parameter - Time to Maximum Plasma Concentration [Tmax]
Pharmacokinetic (PK) Parameter - Maximum Plasma Concentration [Cmax]
Pharmacokinetic Parameter - Area Under the Plasma Concentration-Time Curve [AUC0-t]
Pharmacokinetic (PK) Parameter - Half-Life [t1/2]
Objective Response Rate (ORR) by Study Milestone in the Peripheral T-Cell Lymphoma (Combination Therapy) Cohort That Enrolled Patients Beyond Stage 1 or in the Peripheral T-Cell Lymphoma (Monotherapy) Cohort Who Crossed Over to Receive Combination Therapy
Duration of Response (DOR) by Study Milestone in the Peripheral T-Cell Lymphoma (Combination Therapy) Cohort That Enrolled Patients Beyond Stage 1 or in the Peripheral T-Cell Lymphoma (Monotherapy) Cohort Who Crossed Over to Receive Combination Therapy
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Key Inclusion Criteria: * EBV+ DLBCL, NOS and PTCL, NOS, and AITL: Relapsed/refractory disease following 1 or more prior systemic therapy(ies) with curative intent. * For EBV+ PTLD patients: Relapsed/refractory disease following 1 prior therapy and must have received at least 1 course of an anti-CD20 immunotherapy. For patients with EBV+ PTLD only, age 12 years and older and weighing greater than 40 kg (Adolescent, Adult, Older Adult) are allowed * For other EBV+ relapsed/refractory lymphoma: Following at least 1 course of an anit-CD20 immunotherapy and at least 1 course of anthracycline-based chemotherapy (unless contraindicated) * No available therapies in the opinion of the Investigator * Not eligible for high-dose chemotherapy with allogeneic/autologous stem cell transplantation or CAR-T therapy * Measurable disease per Cheson 2007 * ECOG performance status 0, 1, 2 * Adequate bone marrow function Key Exclusion Criteria: * Presence or history of CNS involvement by lymphoma * Systemic anticancer therapy or CAR-T within 21 days * Antibody (anticancer) agents within 28 days * Less than 60 days from prior autologous hematopoietic stem cell or solid organ transplant * Less than 90 days from prior allogeneic transplant. * Daily corticosteroids (≥20 mg of prednisone or equivalent) within week prior to Cycle 1 Day 1 * Inability to take oral medication, malabsorption syndrome or any other gastrointestinal condition (nausea, diarrhea, vomiting) that may impact the absorption of nanatinostat and valganciclovir. * Active infection requiring systemic therapy (excluding viral upper respiratory tract infections).
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Patients will receive nanatinostat 20 mg orally once daily, days 1-4 per week with valganciclovir 900 mg orally once daily. Up to 10 PTCL patients will receive nanatinostat 20 mg orally once daily, days 1-4 per week.
- intervention Names
- Drug: Nanatinostat in combination with valganciclovir
- label
- Nanatinostat with Valganciclovir
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Nanatinostat with Valganciclovir
- description
- Drug: Nanatinostat, 20 mg orally once daily, 4 days per week in 28 day cycles Drug: Valganciclovir, 900 mg orally once daily in 28 day cycles
- name
- Nanatinostat in combination with valganciclovir
- other Names
- VRx-3996 in combination with Valcyte
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- intervention Model Description
- This is an open-label, single-arm study utilizing a basket trial design. The study was terminated prematurely and did not reach its target enrollment.
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 102
- type
- ACTUAL
Registered outcome plans (not posted results)
- other Outcomes
- description
- 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.
- measure
- Objective Response Rate (ORR) by Study Milestone in the Peripheral T-Cell Lymphoma (Combination Therapy) Cohort That Enrolled Patients Beyond Stage 1 or in the Peripheral T-Cell Lymphoma (Monotherapy) Cohort Who Crossed Over to Receive Combination Therapy
- time Frame
- Up to approximately 2 years
- description
- 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.
- measure
- Duration of Response (DOR) by Study Milestone in the Peripheral T-Cell Lymphoma (Combination Therapy) Cohort That Enrolled Patients Beyond Stage 1 or in the Peripheral T-Cell Lymphoma (Monotherapy) Cohort Who Crossed Over to Receive Combination Therapy
- time Frame
- Up to approximately 2 years
- primary Outcomes
- description
- 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.
- measure
- Objective Response Rate (ORR)
- time Frame
- Up to approximately 2 years
- secondary Outcomes
- description
- 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.
- measure
- Duration of Response (DOR)
- time Frame
- Up to approximately 2 years
- description
- Interval of time from the start of study drug treatment to the date of next anti-lymphoma treatment (including chemotherapy, radiotherapy, radioimmunotherapy, or immunotherapy).
- measure
- Time to Next Anti-Lymphoma Treatment (TTNLT)
- time Frame
- Up to approximately 3 years
- description
- 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.
- measure
- Time to Progression (TTP)
- time Frame
- Up to approximately 3 years
- description
- 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.
- measure
- Progression-Free Survival (PFS)
- time Frame
- Up to approximately 3 years
- description
- 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.
- measure
- Overall Survival (OS)
- time Frame
- Up to approximately 3 years
- description
- 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
- measure
- Number (Percentage) of Participants With Adverse Events (AEs)
- time Frame
- Up to approximately 2 years
- description
- Defined as the time required to reach peak plasma concentration \[Cmax\] after study drug administration
- measure
- Pharmacokinetic (PK) Parameter - Time to Maximum Plasma Concentration [Tmax]
- time Frame
- 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)
- description
- Defined as the peak plasma concentration \[Cmax\] after study drug administration
- measure
- Pharmacokinetic (PK) Parameter - Maximum Plasma Concentration [Cmax]
- time Frame
- 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)
- description
- Defined as the area under the concentration-time curve from time 0 to the last measurable plasma concentration
- measure
- Pharmacokinetic Parameter - Area Under the Plasma Concentration-Time Curve [AUC0-t]
- time Frame
- 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)
- description
- Defined as the time required to reduce plasma concentration by 50% after study drug administration
- measure
- Pharmacokinetic (PK) Parameter - Half-Life [t1/2]
- time Frame
- 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)
Full study description
- brief Summary
- A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas
- detailed Description
- Patients with EBV-associated lymphomas have inferior outcomes with standard-of-care therapies compared to those with EBV-negative disease. Nanatinostat is a selective class I HDAC inhibitor which induces EBV lytic phase protein generation, activating (val)ganciclovir to its cytotoxic form. This open-label, multicenter, multinational, single-arm, Phase 2 basket study employs a Simon's 2-stage design to allow termination of enrollment into cohorts where treatment appears futile, and will include the following cohorts of patients with EBV+ relapsed/refractory lymphomas: 1. Diffuse large B-cell lymphoma (DLBCL) 2. Extranodal natural killer/T-cell lymphoma (ENKTL) 3. Peripheral T-cell lymphoma (PTCL), including angioimmunoblastic T-cell lymphoma (AITL) and PTCL not otherwise specified (PTCL-NOS) 4. Hodgkin lymphoma (HL) 5. Post-transplant lymphoproliferative disorders (PTLD) 6. Human immunodeficiency virus (HIV)-associated lymphomas (HIV-L) 7. EBV+ lymphomas other than the above The study was terminated prematurely and did not reach its target enrollment.
Source references
- references
- citation
- Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22.
- pmid
- 17242396
- type
- BACKGROUND
- citation
- 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.
- pmid
- 37530631
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice