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NCT05011058 · OUTCOME

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

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

Groups in this outcome

Stage 1 (Peripheral T-Cell Lymphoma)

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 in the first stage of the study

Stage 1 (Peripheral T-Cell Lymphoma - Second Line)

Patients with second-line 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 in the first stage of the study

Stage 2 (Peripheral T-Cell Lymphoma)

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 in the second stage of the study

Stage 2 (Peripheral T-Cell Lymphoma - Second Line)

Patients with second-line 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 in the second stage of the study

Expansion (Peripheral T-Cell Lymphoma)

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 in the expansion stage of the study

Expansion (Peripheral T-Cell Lymphoma - Second Line)

Patients with second-line 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 in the expansion stage of the study

Peripheral T-Cell Lymphoma (Crossover)

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 after having been treated with nanatinostat 20 mg QD on Days 1 to 4 per week without response in the monotherapy cohort

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

Analysis denominator · Participants

GroupSource count
Stage 1 (Peripheral T-Cell Lymphoma)5
Stage 1 (Peripheral T-Cell Lymphoma - Second Line)5
Stage 2 (Peripheral T-Cell Lymphoma)2
Stage 2 (Peripheral T-Cell Lymphoma - Second Line)1
Expansion (Peripheral T-Cell Lymphoma)4
Expansion (Peripheral T-Cell Lymphoma - Second Line)1
Peripheral T-Cell Lymphoma (Crossover)2

Reported measurements

Source class 1
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Stage 1 (Peripheral T-Cell Lymphoma)86Not reported36340Not reported
Stage 1 (Peripheral T-Cell Lymphoma - Second Line)86Not reported36340Not reported
Stage 2 (Peripheral T-Cell Lymphoma)125Not reported29221Not reported
Stage 2 (Peripheral T-Cell Lymphoma - Second Line)29Not reported2929Not reported
Expansion (Peripheral T-Cell Lymphoma)99Not reported73126Not reported
Expansion (Peripheral T-Cell Lymphoma - Second Line)73Not reported7373Not reported
Peripheral T-Cell Lymphoma (Crossover)192Not reported79305Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        36
        upper Limit
        340
        value
        86
      2. group Id
        OG001
        lower Limit
        36
        upper Limit
        340
        value
        86
      3. group Id
        OG002
        lower Limit
        29
        upper Limit
        221
        value
        125
      4. group Id
        OG003
        lower Limit
        29
        upper Limit
        29
        value
        29
      5. group Id
        OG004
        lower Limit
        73
        upper Limit
        126
        value
        99
      6. group Id
        OG005
        lower Limit
        73
        upper Limit
        73
        value
        73
      7. group Id
        OG006
        lower Limit
        79
        upper Limit
        305
        value
        192
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      2
    4. group Id
      OG003
      value
      1
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      1
    7. group Id
      OG006
      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 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 in the first stage of the study
    id
    OG000
    title
    Stage 1 (Peripheral T-Cell Lymphoma)
  2. description
    Patients with second-line 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 in the first stage of the study
    id
    OG001
    title
    Stage 1 (Peripheral T-Cell Lymphoma - Second Line)
  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 in the second stage of the study
    id
    OG002
    title
    Stage 2 (Peripheral T-Cell Lymphoma)
  4. description
    Patients with second-line 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 in the second stage of the study
    id
    OG003
    title
    Stage 2 (Peripheral T-Cell Lymphoma - Second Line)
  5. 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 in the expansion stage of the study
    id
    OG004
    title
    Expansion (Peripheral T-Cell Lymphoma)
  6. description
    Patients with second-line 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 in the expansion stage of the study
    id
    OG005
    title
    Expansion (Peripheral T-Cell Lymphoma - Second Line)
  7. 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 after having been treated with nanatinostat 20 mg QD on Days 1 to 4 per week without response in the monotherapy cohort
    id
    OG006
    title
    Peripheral T-Cell Lymphoma (Crossover)
param Type
MEDIAN
population Description
Patients who achieved a CR or PR
reporting Status
POSTED
time Frame
Up to approximately 2 years
title
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
type
OTHER_PRE_SPECIFIED
unit Of Measure
days

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

Preserved source evidence · Not medical advice