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NCT05011058 · FLOW

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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.

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
    FG000
    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
    FG001
    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
    FG002
    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
    FG003
    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
    FG004
    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
    FG005
    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
    FG006
    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
    FG007
    title
    Other EBV-Positive Lymphomas
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        14
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        5
      type
      Sponsor Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        38
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        8
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        20
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        9
      2. comment
        More than 10 patients were enrolled in Stage 1 of the Extranodal Natural Killer/T-Cell Lymphoma cohort because the tenth and eleventh patients had signed informed consent concurrently.
        group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        8
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        3
      8. comment
        No more than 10 patients of a given lymphoma subtype were enrolled in Stage 1 of the Other EBV-Positive Lymphomas cohort.
        group Id
        FG007
        num Subjects
        20
      type
      Stage 1
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        11
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Stage 2
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        17
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Expansion
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      comment
      Crossover only applies to patients enrolled in the Peripheral T-Cell Lymphoma (Monotherapy) cohort who were subsequently provided the option to cross over to receive combination therapy.
      type
      Crossover
    6. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        24
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        8
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        15
      type
      COMPLETED
    7. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        14
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Patients enrolled in the Peripheral T-Cell Lymphoma (Monotherapy) cohort who had stable disease at 6 weeks or disease progression at any time (confirmed by CT or MRI) were provided the option to cross over to receive combination therapy for the remainder of the study.
recruitment Details
Patients with Epstein-Barr virus (EBV)-associated lymphoid malignancy were nonrandomly assigned to one of 7 cohorts defined in the Study Description module, except the first 20 patients with peripheral T-cell lymphoma were randomized (1:1) to receive either combination nanatinostat plus valganciclovir therapy or nanatinostat monotherapy. Up to 10 (Stage 1), up to 11 (Stage 2), and up to 120 (Expansion) patients were to be enrolled in each cohort depending on the number of responses observed.
Complete source fields
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
    FG000
    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
    FG001
    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
    FG002
    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
    FG003
    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
    FG004
    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
    FG005
    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
    FG006
    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
    FG007
    title
    Other EBV-Positive Lymphomas
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        14
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        5
      type
      Sponsor Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        38
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        8
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        20
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        9
      2. comment
        More than 10 patients were enrolled in Stage 1 of the Extranodal Natural Killer/T-Cell Lymphoma cohort because the tenth and eleventh patients had signed informed consent concurrently.
        group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        8
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        3
      8. comment
        No more than 10 patients of a given lymphoma subtype were enrolled in Stage 1 of the Other EBV-Positive Lymphomas cohort.
        group Id
        FG007
        num Subjects
        20
      type
      Stage 1
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        11
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Stage 2
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        17
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Expansion
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      comment
      Crossover only applies to patients enrolled in the Peripheral T-Cell Lymphoma (Monotherapy) cohort who were subsequently provided the option to cross over to receive combination therapy.
      type
      Crossover
    6. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        24
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        8
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        15
      type
      COMPLETED
    7. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        14
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Patients enrolled in the Peripheral T-Cell Lymphoma (Monotherapy) cohort who had stable disease at 6 weeks or disease progression at any time (confirmed by CT or MRI) were provided the option to cross over to receive combination therapy for the remainder of the study.
recruitment Details
Patients with Epstein-Barr virus (EBV)-associated lymphoid malignancy were nonrandomly assigned to one of 7 cohorts defined in the Study Description module, except the first 20 patients with peripheral T-cell lymphoma were randomized (1:1) to receive either combination nanatinostat plus valganciclovir therapy or nanatinostat monotherapy. Up to 10 (Stage 1), up to 11 (Stage 2), and up to 120 (Expansion) patients were to be enrolled in each cohort depending on the number of responses observed.

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Preserved source evidence · Not medical advice