Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02232516 · FLOW

Participant flow

Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymphoma · Source last updated 2026-06-12

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

groups
  1. description
    Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV lenalidomide: Given PO laboratory biomarker analysis: Correlative studies
    id
    FG000
    title
    Treatment (Romidepsin, Lenalidomide)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      No Response
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Screen failure
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Disease Progression
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        30
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        29
      type
      Cycle 1
    3. achievements
      1. group Id
        FG000
        num Subjects
        23
      type
      Cycle 2
    4. achievements
      1. group Id
        FG000
        num Subjects
        20
      type
      Cycle 3
    5. achievements
      1. group Id
        FG000
        num Subjects
        23
      type
      1st Response Assessment
    6. achievements
      1. group Id
        FG000
        num Subjects
        20
      type
      COMPLETED
    7. achievements
      1. group Id
        FG000
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Study Treatment Period: Cycles 1-3
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Disease Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        20
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        15
      type
      Cycle 4
    3. achievements
      1. group Id
        FG000
        num Subjects
        13
      type
      Cycle 5
    4. achievements
      1. group Id
        FG000
        num Subjects
        13
      type
      Cycle 6
    5. achievements
      1. group Id
        FG000
        num Subjects
        12
      type
      2nd Response Assessment
    6. achievements
      1. group Id
        FG000
        num Subjects
        13
      type
      COMPLETED
    7. achievements
      1. group Id
        FG000
        num Subjects
        7
      type
      NOT COMPLETED
    title
    Study Treatment Period: Cycles 4-6
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Disease Progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        13
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        6
      type
      Cycle 7
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      type
      Cycle 8
    4. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      Cycle 9
    5. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      3rd Response Assessment
    6. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      COMPLETED
    7. achievements
      1. group Id
        FG000
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Study Treatment Period: Cycles 7-9
  4. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Disease Progression
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      Cycle 10
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      Cycle 11
    4. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      Cycle 12
    5. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Study Treatment Period: Cycles 10-12
  5. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        15
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Still in follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        29
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        5
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Survival Follow-up
recruitment Details
The target population for this phase II study is patients with histologically confirmed (previously untreated) peripheral T-cell lymphoma (PTCL). Northwestern University will serve was the lead site and coordinating center for this study. Participating sites included Weill Cornell Medical College, and City of Hope. Enrollment began on 06/11/2015 at Northwestern University, 05/24/2017 at City of Hope, 12/14/2016 at Cornell University.
Complete source fields
groups
  1. description
    Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV lenalidomide: Given PO laboratory biomarker analysis: Correlative studies
    id
    FG000
    title
    Treatment (Romidepsin, Lenalidomide)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      No Response
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Screen failure
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Disease Progression
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        30
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        29
      type
      Cycle 1
    3. achievements
      1. group Id
        FG000
        num Subjects
        23
      type
      Cycle 2
    4. achievements
      1. group Id
        FG000
        num Subjects
        20
      type
      Cycle 3
    5. achievements
      1. group Id
        FG000
        num Subjects
        23
      type
      1st Response Assessment
    6. achievements
      1. group Id
        FG000
        num Subjects
        20
      type
      COMPLETED
    7. achievements
      1. group Id
        FG000
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Study Treatment Period: Cycles 1-3
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Disease Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        20
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        15
      type
      Cycle 4
    3. achievements
      1. group Id
        FG000
        num Subjects
        13
      type
      Cycle 5
    4. achievements
      1. group Id
        FG000
        num Subjects
        13
      type
      Cycle 6
    5. achievements
      1. group Id
        FG000
        num Subjects
        12
      type
      2nd Response Assessment
    6. achievements
      1. group Id
        FG000
        num Subjects
        13
      type
      COMPLETED
    7. achievements
      1. group Id
        FG000
        num Subjects
        7
      type
      NOT COMPLETED
    title
    Study Treatment Period: Cycles 4-6
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Disease Progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        13
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        6
      type
      Cycle 7
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      type
      Cycle 8
    4. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      Cycle 9
    5. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      3rd Response Assessment
    6. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      COMPLETED
    7. achievements
      1. group Id
        FG000
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Study Treatment Period: Cycles 7-9
  4. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Disease Progression
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      Cycle 10
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      Cycle 11
    4. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      Cycle 12
    5. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Study Treatment Period: Cycles 10-12
  5. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        15
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Still in follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        29
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        5
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Survival Follow-up
recruitment Details
The target population for this phase II study is patients with histologically confirmed (previously untreated) peripheral T-cell lymphoma (PTCL). Northwestern University will serve was the lead site and coordinating center for this study. Participating sites included Weill Cornell Medical College, and City of Hope. Enrollment began on 06/11/2015 at Northwestern University, 05/24/2017 at City of Hope, 12/14/2016 at Cornell University.

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

Preserved source evidence · Not medical advice