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NCT00632827 · FLOW

Participant flow

Treatment of PTCL With Aggressive Induction Therapy Followed by Autologous SCT Using Denileukin Diftitox (Ontak) · Source last updated 2020-04-27

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

groups
  1. description
    All patients will be given allopurinol 600 mg/day PO on day 1 of induction chemotherapy, and then 300 mg/day. Patients then receive two cycles of gemcitabine, vinorelbine, Doxil (GVD) followed by two cycles of augmented dose Cyclophosphamide (CHOP) plus high-dose Methotrexate (MTX). Patients were restaged after 2 cycles of GVD and again after the second cycle of augmented CHOP/high-dose MTX. Those achieving a remission status received intensive consolidation with Idarubicin/cytosine arabinoside(iDAC)/etoposide followed by stem cell mobilization and 5-day course of denileukin diftitox (Ontak) will be administered followed by autologous stem cell transplant. Those not achieving partial remission or better following the four induction courses will receive 2 cycles of denileukin diftitox(Ontak) for 5 days. Those achieving partial remission or better to this regimen moved to consolidation/mobilization and autologous stem cell transplant.
    id
    FG000
    title
    Treatment Plan
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Excluded after GVD (Not evaluable)
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        21
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        21
      type
      Received GVD
    3. achievements
      1. group Id
        FG000
        num Subjects
        18
      type
      Received M-CHOP
    4. achievements
      1. group Id
        FG000
        num Subjects
        16
      type
      Evaluated Post Stem Cell Transplant
    5. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    All patients will be given allopurinol 600 mg/day PO on day 1 of induction chemotherapy, and then 300 mg/day. Patients then receive two cycles of gemcitabine, vinorelbine, Doxil (GVD) followed by two cycles of augmented dose Cyclophosphamide (CHOP) plus high-dose Methotrexate (MTX). Patients were restaged after 2 cycles of GVD and again after the second cycle of augmented CHOP/high-dose MTX. Those achieving a remission status received intensive consolidation with Idarubicin/cytosine arabinoside(iDAC)/etoposide followed by stem cell mobilization and 5-day course of denileukin diftitox (Ontak) will be administered followed by autologous stem cell transplant. Those not achieving partial remission or better following the four induction courses will receive 2 cycles of denileukin diftitox(Ontak) for 5 days. Those achieving partial remission or better to this regimen moved to consolidation/mobilization and autologous stem cell transplant.
    id
    FG000
    title
    Treatment Plan
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Excluded after GVD (Not evaluable)
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        21
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        21
      type
      Received GVD
    3. achievements
      1. group Id
        FG000
        num Subjects
        18
      type
      Received M-CHOP
    4. achievements
      1. group Id
        FG000
        num Subjects
        16
      type
      Evaluated Post Stem Cell Transplant
    5. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Overall Study

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

Preserved source evidence · Not medical advice