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NCT05011058 · OUTCOME

Objective Response Rate (ORR)

An Open-Label Phase 2 Trial of Nanatinostat Plus Valganciclovir in Patients With EBV+ Relapsed/Refractory Lymphomas · Source last updated 2025-07-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to approximately 2 years

What was measured

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.

Analysis population: 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.

Groups in this outcome

Diffuse Large B-Cell Lymphoma

Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD

Extranodal Natural Killer/T-Cell Lymphoma

Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD

Peripheral T-Cell Lymphoma (Combination Therapy)

Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD

Peripheral T-Cell Lymphoma (Monotherapy)

Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week

Hodgkin Lymphoma

Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD

Post-Transplant Lymphoproliferative Disorders

Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD

Human Immunodeficiency Virus-Associated Lymphomas

Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD

Other EBV-Positive Lymphomas

Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Diffuse Large B-Cell Lymphoma9
Extranodal Natural Killer/T-Cell Lymphoma11
Peripheral T-Cell Lymphoma (Combination Therapy)38
Peripheral T-Cell Lymphoma (Monotherapy)10
Hodgkin Lymphoma8
Post-Transplant Lymphoproliferative Disorders3
Human Immunodeficiency Virus-Associated Lymphomas3
Other EBV-Positive Lymphomas20

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Diffuse Large B-Cell Lymphoma0Not reportedNot reportedNot reportedNot reported
Extranodal Natural Killer/T-Cell Lymphoma0Not reportedNot reportedNot reportedNot reported
Peripheral T-Cell Lymphoma (Combination Therapy)11Not reportedNot reportedNot reportedNot reported
Peripheral T-Cell Lymphoma (Monotherapy)1Not reportedNot reportedNot reportedNot reported
Hodgkin Lymphoma0Not reportedNot reportedNot reportedNot reported
Post-Transplant Lymphoproliferative Disorders0Not reportedNot reportedNot reportedNot reported
Human Immunodeficiency Virus-Associated Lymphomas0Not reportedNot reportedNot reportedNot reported
Other EBV-Positive Lymphomas2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        11
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    2. group Id
      OG001
      value
      11
    3. group Id
      OG002
      value
      38
    4. group Id
      OG003
      value
      10
    5. group Id
      OG004
      value
      8
    6. group Id
      OG005
      value
      3
    7. group Id
      OG006
      value
      3
    8. group Id
      OG007
      value
      20
    units
    Participants
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.
groups
  1. description
    Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD
    id
    OG000
    title
    Diffuse Large B-Cell Lymphoma
  2. description
    Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD
    id
    OG001
    title
    Extranodal Natural Killer/T-Cell Lymphoma
  3. description
    Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD
    id
    OG002
    title
    Peripheral T-Cell Lymphoma (Combination Therapy)
  4. description
    Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week
    id
    OG003
    title
    Peripheral T-Cell Lymphoma (Monotherapy)
  5. description
    Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD
    id
    OG004
    title
    Hodgkin Lymphoma
  6. description
    Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD
    id
    OG005
    title
    Post-Transplant Lymphoproliferative Disorders
  7. description
    Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD
    id
    OG006
    title
    Human Immunodeficiency Virus-Associated Lymphomas
  8. description
    Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD
    id
    OG007
    title
    Other EBV-Positive Lymphomas
param Type
COUNT_OF_PARTICIPANTS
population Description
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.
reporting Status
POSTED
time Frame
Up to approximately 2 years
title
Objective Response Rate (ORR)
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice