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NCT00632827 · OUTCOME

Complete Response Rate

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 3 years

What was measured

The complete response rate will be defined as the total number of patients who have defined complete response using study regimen (intensive induction therapy/progressive chemotherapy/stem cell rescue), divided by the number of patients entered in the trial using response-evaluable patients.

Groups in this outcome

Treatment Plan

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 (GND) followed by two cycles of augmented dose Cyclophosphamide (CHOP) plus high-dose Methotrexate (MTX). Patients were restaged after 2 cycles of GND and again after the second cycle of augmented CHOP/high-dose MTX. Those achieving a remission status received intensive consolidation with 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.

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

Analysis denominator · Participants

GroupSource count
Treatment Plan21

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Plan14Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        14
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    units
    Participants
description
The complete response rate will be defined as the total number of patients who have defined complete response using study regimen (intensive induction therapy/progressive chemotherapy/stem cell rescue), divided by the number of patients entered in the trial using response-evaluable patients.
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 (GND) followed by two cycles of augmented dose Cyclophosphamide (CHOP) plus high-dose Methotrexate (MTX). Patients were restaged after 2 cycles of GND and again after the second cycle of augmented CHOP/high-dose MTX. Those achieving a remission status received intensive consolidation with 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
    OG000
    title
    Treatment Plan
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 3 years
title
Complete Response Rate
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice