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NCT02689453 · OUTCOME

Number of Participants With Serious Adverse Events Possibly, Probably, and/or Definitely Related to Subcutaneous (s.c. rhIL-15) by Grade Who Have Refractory or Relapsed Chronic and Acute Adult T-cell Leukemia (ATL)Cancer

Subcutaneous Recombinant Human IL-15 (s.c. rhIL-15) and Alemtuzumab for People With Refractory or Relapsed Chronic and Acute Adult T-cell Leukemia (ATL) · Source last updated 2022-04-29

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
Date treatment consent signed to date off study, approximately 16 months and 14 days for level 1, 18 months and 12 days for level 2, and 14 months and 24 days for level 3.

What was measured

Here is the number of participants with serious adverse events possibly, probably, and/or definitely related to IL-15 (s.c. rhIL-15) by Grade assessed by the Common Terminology Criteria for Adverse Events (CTCAE 5.0). A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to adverse event.

Groups in this outcome

Level 1 - 0.5 mcg/kg/Dose of Interleukin 15 (IL-15)

IL-15 for 10 doses over two weeks IL-15 plus: Recombinant Human IL-15 (subcutaneous (s.c.) rhIL-15) by s.c. injection Monday-Friday over two weeks.

Level 2 - 1 mcg/kg/Dose of Interleukin-15 (IL-15) Followed by Alemtuzumab

IL-15 for 10 doses over two weeks followed by alemtuzumab for 4 weeks IL-15 plus: Recombinant Human IL-15 (subcutaneous (s.c.) rhIL-15) by s.c. injection Monday-Friday over two weeks. alemtuzumab: Alemtuzumab three times a week for a total of 4 weeks of alemtuzumab treatment.

Level 3 - 2 mcg/kg/Dose of Interleukin 15 (IL-15) Followed by Alemtuzumab

IL-15 for 10 doses over two weeks followed by alemtuzumab for 4 weeks IL-15 plus: Recombinant Human IL-15 (subcutaneous (s.c.) rhIL-15) by s.c. injection Monday-Friday over two weeks. alemtuzumab: Alemtuzumab three times a week for a total of 4 weeks of alemtuzumab treatment.

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

Analysis denominator · Participants

GroupSource count
Level 1 - 0.5 mcg/kg/Dose of Interleukin 15 (IL-15)3
Level 2 - 1 mcg/kg/Dose of Interleukin-15 (IL-15) Followed by Alemtuzumab4
Level 3 - 2 mcg/kg/Dose of Interleukin 15 (IL-15) Followed by Alemtuzumab4

Reported measurements

Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Level 1 - 0.5 mcg/kg/Dose of Interleukin 15 (IL-15)1Not reportedNot reportedNot reportedNot reported
Level 2 - 1 mcg/kg/Dose of Interleukin-15 (IL-15) Followed by Alemtuzumab1Not reportedNot reportedNot reportedNot reported
Level 3 - 2 mcg/kg/Dose of Interleukin 15 (IL-15) Followed by Alemtuzumab1Not reportedNot reportedNot reportedNot reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Level 1 - 0.5 mcg/kg/Dose of Interleukin 15 (IL-15)0Not reportedNot reportedNot reportedNot reported
Level 2 - 1 mcg/kg/Dose of Interleukin-15 (IL-15) Followed by Alemtuzumab0Not reportedNot reportedNot reportedNot reported
Level 3 - 2 mcg/kg/Dose of Interleukin 15 (IL-15) Followed by Alemtuzumab1Not reportedNot reportedNot reportedNot reported
Grade 5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Level 1 - 0.5 mcg/kg/Dose of Interleukin 15 (IL-15)0Not reportedNot reportedNot reportedNot reported
Level 2 - 1 mcg/kg/Dose of Interleukin-15 (IL-15) Followed by Alemtuzumab0Not reportedNot reportedNot reportedNot reported
Level 3 - 2 mcg/kg/Dose of Interleukin 15 (IL-15) Followed by Alemtuzumab0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
    title
    Grade 3
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Grade 4
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Grade 5
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      4
    units
    Participants
description
Here is the number of participants with serious adverse events possibly, probably, and/or definitely related to IL-15 (s.c. rhIL-15) by Grade assessed by the Common Terminology Criteria for Adverse Events (CTCAE 5.0). A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to adverse event.
groups
  1. description
    IL-15 for 10 doses over two weeks IL-15 plus: Recombinant Human IL-15 (subcutaneous (s.c.) rhIL-15) by s.c. injection Monday-Friday over two weeks.
    id
    OG000
    title
    Level 1 - 0.5 mcg/kg/Dose of Interleukin 15 (IL-15)
  2. description
    IL-15 for 10 doses over two weeks followed by alemtuzumab for 4 weeks IL-15 plus: Recombinant Human IL-15 (subcutaneous (s.c.) rhIL-15) by s.c. injection Monday-Friday over two weeks. alemtuzumab: Alemtuzumab three times a week for a total of 4 weeks of alemtuzumab treatment.
    id
    OG001
    title
    Level 2 - 1 mcg/kg/Dose of Interleukin-15 (IL-15) Followed by Alemtuzumab
  3. description
    IL-15 for 10 doses over two weeks followed by alemtuzumab for 4 weeks IL-15 plus: Recombinant Human IL-15 (subcutaneous (s.c.) rhIL-15) by s.c. injection Monday-Friday over two weeks. alemtuzumab: Alemtuzumab three times a week for a total of 4 weeks of alemtuzumab treatment.
    id
    OG002
    title
    Level 3 - 2 mcg/kg/Dose of Interleukin 15 (IL-15) Followed by Alemtuzumab
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Date treatment consent signed to date off study, approximately 16 months and 14 days for level 1, 18 months and 12 days for level 2, and 14 months and 24 days for level 3.
title
Number of Participants With Serious Adverse Events Possibly, Probably, and/or Definitely Related to Subcutaneous (s.c. rhIL-15) by Grade Who Have Refractory or Relapsed Chronic and Acute Adult T-cell Leukemia (ATL)Cancer
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice