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NCT02911142 · FLOW

Participant flow

Lenalidomide Combined With Modified DA-EPOCH and Rituximab (EPOCH-R2) in Primary Effusion Lymphoma or KSHV-associated Large Cell Lymphoma · Source last updated 2026-08-26

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

groups
  1. description
    Cohort 1, Dose Level 1 - Lenalidomide 25mg by mouth (PO) was given on days 1 to 10, plus, etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). During cycle 1, Etoposide 50mg/m\^2/day, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin 10 mg /m\^2/day were given as continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin were given as continuous intravenous infusion days 1 to 4. During cycles 2-6, doses of etoposide and doxorubicin were adjusted based on hematologic parameters during the previous cycle. During cycle 1, Prednisone 60 mg/m\^2 /day PO days 6 to 10. During cycles 2-6, Prednisone 60 mg/m\^2 /day PO days 1-5. During cycle 1, Cyclophosphamide 750 mg/m\^2 was given on day 10. During cycles 2-6, Cyclophosphamide 750 mg/m\^2 was given on day 5. Rituximab was administered on day 4 prior to the start of EPOCH during cycle 1 and on day 1 during cycles 2 to 6.
    id
    FG000
    title
    Lenalidomide+Etoposide Phosphate, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin & Rituximab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Did not complete last cycle of EPOCH-R2 due to progressive disease.
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        6
      type
      Received specified dose
    3. achievements
      1. group Id
        FG000
        num Subjects
        6
      type
      Underwent screening/staging
    4. achievements
      1. group Id
        FG000
        num Subjects
        6
      type
      Evaluated for response
    5. achievements
      1. group Id
        FG000
        num Subjects
        6
      type
      Off treatment
    6. achievements
      1. group Id
        FG000
        num Subjects
        6
      type
      Off study
    7. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      Disease progression on study
    8. achievements
      1. group Id
        FG000
        num Subjects
        5
      type
      COMPLETED
    9. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Phase I - Safety & Tolerability
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Refused further treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      Received specified dose
    3. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      Evaluated for response
    4. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      Off treatment
    5. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      Off study
    6. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      Disease progression on study
    7. achievements
      1. group Id
        FG000
        num Subjects
        7
      type
      COMPLETED
    8. achievements
      1. group Id
        FG000
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Phase II - Recommended Phase 2 Dose
Complete source fields
groups
  1. description
    Cohort 1, Dose Level 1 - Lenalidomide 25mg by mouth (PO) was given on days 1 to 10, plus, etoposide phosphate, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). During cycle 1, Etoposide 50mg/m\^2/day, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin 10 mg /m\^2/day were given as continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide, Vincristine 0.4 mg/m\^2 /day, and Doxorubicin were given as continuous intravenous infusion days 1 to 4. During cycles 2-6, doses of etoposide and doxorubicin were adjusted based on hematologic parameters during the previous cycle. During cycle 1, Prednisone 60 mg/m\^2 /day PO days 6 to 10. During cycles 2-6, Prednisone 60 mg/m\^2 /day PO days 1-5. During cycle 1, Cyclophosphamide 750 mg/m\^2 was given on day 10. During cycles 2-6, Cyclophosphamide 750 mg/m\^2 was given on day 5. Rituximab was administered on day 4 prior to the start of EPOCH during cycle 1 and on day 1 during cycles 2 to 6.
    id
    FG000
    title
    Lenalidomide+Etoposide Phosphate, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin & Rituximab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Did not complete last cycle of EPOCH-R2 due to progressive disease.
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        6
      type
      Received specified dose
    3. achievements
      1. group Id
        FG000
        num Subjects
        6
      type
      Underwent screening/staging
    4. achievements
      1. group Id
        FG000
        num Subjects
        6
      type
      Evaluated for response
    5. achievements
      1. group Id
        FG000
        num Subjects
        6
      type
      Off treatment
    6. achievements
      1. group Id
        FG000
        num Subjects
        6
      type
      Off study
    7. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      Disease progression on study
    8. achievements
      1. group Id
        FG000
        num Subjects
        5
      type
      COMPLETED
    9. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Phase I - Safety & Tolerability
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Refused further treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      Received specified dose
    3. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      Evaluated for response
    4. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      Off treatment
    5. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      Off study
    6. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      Disease progression on study
    7. achievements
      1. group Id
        FG000
        num Subjects
        7
      type
      COMPLETED
    8. achievements
      1. group Id
        FG000
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Phase II - Recommended Phase 2 Dose

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Preserved source evidence · Not medical advice