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NCT05011058 · OUTCOME

Duration of Response (DOR)

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
MEDIAN
Unit
days
Interval / dispersion
Full Range
Time frame
Up to approximately 2 years

What was measured

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.

Analysis population: Patients who achieved a CR or PR. The study was not designed to make formal statistical comparisons of DOR 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 Lymphoma0
Extranodal Natural Killer/T-Cell Lymphoma0
Peripheral T-Cell Lymphoma (Combination Therapy)11
Peripheral T-Cell Lymphoma (Monotherapy)1
Hodgkin Lymphoma0
Post-Transplant Lymphoproliferative Disorders0
Human Immunodeficiency Virus-Associated Lymphomas0
Other EBV-Positive Lymphomas2

Reported measurements

Source class 1
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Peripheral T-Cell Lymphoma (Combination Therapy)98Not reported29340Not reported
Peripheral T-Cell Lymphoma (Monotherapy)43Not reported4343Not reported
Other EBV-Positive Lymphomas163.5Not reported86241Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG002
        lower Limit
        29
        upper Limit
        340
        value
        98
      2. group Id
        OG003
        lower Limit
        43
        upper Limit
        43
        value
        43
      3. group Id
        OG007
        lower Limit
        86
        upper Limit
        241
        value
        163.5
denoms
  1. counts
    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
    units
    Participants
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.
dispersion Type
Full Range
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
MEDIAN
population Description
Patients who achieved a CR or PR. The study was not designed to make formal statistical comparisons of DOR between cohorts.
reporting Status
POSTED
time Frame
Up to approximately 2 years
title
Duration of Response (DOR)
type
SECONDARY
unit Of Measure
days

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Preserved source evidence · Not medical advice