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NCT05011058 · OUTCOME

Progression-Free Survival (PFS)

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 3 years

What was measured

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.

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 PFS 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 days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Diffuse Large B-Cell Lymphoma81Not reported29165Not reported
Extranodal Natural Killer/T-Cell Lymphoma110Not reported23517Not reported
Peripheral T-Cell Lymphoma (Combination Therapy)124Not reported14410Not reported
Peripheral T-Cell Lymphoma (Monotherapy)95Not reported32171Not reported
Hodgkin Lymphoma82Not reported64313Not reported
Post-Transplant Lymphoproliferative Disorders79Not reported36351Not reported
Human Immunodeficiency Virus-Associated Lymphomas108Not reported64282Not reported
Other EBV-Positive Lymphomas95.5Not reported35311Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        29
        upper Limit
        165
        value
        81
      2. group Id
        OG001
        lower Limit
        23
        upper Limit
        517
        value
        110
      3. group Id
        OG002
        lower Limit
        14
        upper Limit
        410
        value
        124
      4. group Id
        OG003
        lower Limit
        32
        upper Limit
        171
        value
        95
      5. group Id
        OG004
        lower Limit
        64
        upper Limit
        313
        value
        82
      6. group Id
        OG005
        lower Limit
        36
        upper Limit
        351
        value
        79
      7. group Id
        OG006
        lower Limit
        64
        upper Limit
        282
        value
        108
      8. group Id
        OG007
        lower Limit
        35
        upper Limit
        311
        value
        95.5
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
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.
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
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.
reporting Status
POSTED
time Frame
Up to approximately 3 years
title
Progression-Free Survival (PFS)
type
SECONDARY
unit Of Measure
days

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Preserved source evidence · Not medical advice