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NCT02689453 · OUTCOME

Percentages of Circulating Lymphocytes (T and NK Cells) and the T-cell Subsets

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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
At 6 weeks of treatment

What was measured

Biological effects of rhIL-15 administered with alemtuzumab on the percentages of circulating lymphocytes (T and NK cells) and the T-cell subsets naïve, central and effector memory subsets (based on expression of cluster of differentiation 52 (CD52), neural cell adhesion molecule (CD56), cluster of differentiation 4 (CD4), cluster of differentiation 8 (CD8), memory T cells (CD45RO), memory T cells (CD45RA), cluster of differentiation 28 (CD28), apoptosis antigen 1 (CD95), C-C Chemokine Receptor 4 (CD194), C-C Motif Chemokine Receptor 7 (CCR7) and L-selectin (CD62L) using flow cytometry.

Analysis population: These analyses were not performed because there was pan lymphocyte depletion with the initiation of Campath (alemtuzumab) treatment and flow cytometry was not performed and there were not enough circulating lymphocytes to analyze.

Groups in this outcome

Level 1 - 0.5 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 per dosing schema to determine the maximum tolerated dose (MTD) 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 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) Followed by Alemtuzumab0
Level 2 - 1 mcg/kg/Dose of Interleukin-15 (IL-15) Followed by Alemtuzumab0
Level 3 - 2 mcg/kg/Dose of Interleukin 15 (IL-15) Followed by Alemtuzumab0

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
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    units
    Participants
description
Biological effects of rhIL-15 administered with alemtuzumab on the percentages of circulating lymphocytes (T and NK cells) and the T-cell subsets naïve, central and effector memory subsets (based on expression of cluster of differentiation 52 (CD52), neural cell adhesion molecule (CD56), cluster of differentiation 4 (CD4), cluster of differentiation 8 (CD8), memory T cells (CD45RO), memory T cells (CD45RA), cluster of differentiation 28 (CD28), apoptosis antigen 1 (CD95), C-C Chemokine Receptor 4 (CD194), C-C Motif Chemokine Receptor 7 (CCR7) and L-selectin (CD62L) using flow cytometry.
groups
  1. description
    IL-15 for 10 doses over two weeks followed by alemtuzumab for 4 weeks per dosing schema to determine the maximum tolerated dose (MTD) 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
    OG000
    title
    Level 1 - 0.5 mcg/kg/Dose of Interleukin 15 (IL-15) Followed by Alemtuzumab
  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
population Description
These analyses were not performed because there was pan lymphocyte depletion with the initiation of Campath (alemtuzumab) treatment and flow cytometry was not performed and there were not enough circulating lymphocytes to analyze.
reporting Status
POSTED
time Frame
At 6 weeks of treatment
title
Percentages of Circulating Lymphocytes (T and NK Cells) and the T-cell Subsets
type
SECONDARY

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

Preserved source evidence · Not medical advice