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NCT01251952 · OUTCOME

Assess Toxicities of Giving Two Doses of Ontak at Days 0 and 21 Post Autologous Stem Cell Transplantation in a Dose Escalation Fashion.

Dose Escalation Trial of Denileukin Diftitox (Ontak) Post Autologous Transplantation · Source last updated 2017-06-20

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Up to 21 days post transplant

What was measured

After drug infusion, participants will be closely monitored for at least 4 hours for side effects

Groups in this outcome

Denileukin Diftitox (Ontak)

Denileukin Diftitox (Ontak) administered Post Autologous Transplantation. Denileukin Diftitox (Ontak) : After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21. Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360.

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

Analysis denominator · Participants

GroupSource count
Denileukin Diftitox (Ontak)0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
After drug infusion, participants will be closely monitored for at least 4 hours for side effects
groups
  1. description
    Denileukin Diftitox (Ontak) administered Post Autologous Transplantation. Denileukin Diftitox (Ontak) : After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21. Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360.
    id
    OG000
    title
    Denileukin Diftitox (Ontak)
reporting Status
POSTED
time Frame
Up to 21 days post transplant
title
Assess Toxicities of Giving Two Doses of Ontak at Days 0 and 21 Post Autologous Stem Cell Transplantation in a Dose Escalation Fashion.
type
PRIMARY

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

Preserved source evidence · Not medical advice