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NCT00275262 · OUTCOME

Mean Change From Baseline in T Cell Excision Circles (TREC) Per 100,000 CD4+ Cells to Final Visit in Patients Treated With LAD (11.25 mg) or Placebo After Transplant

A Study to Evaluate the Ability of Lupron Depot to Enhance Immune Function Following Bone Marrow Transplantation · Source last updated 2010-05-06

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

Measure
MEAN
Unit
TREC /100,000 CD4+ cells
Interval / dispersion
Standard Deviation
Time frame
Pretransplant and posttransplant (Month 12)

What was measured

CD4+ cells are a type of T cell. T cells are produced in the thymus and thymic function can be determined by TREC. By counting the number of TRECs present (only 1 copy per cell) within a population of CD4 cells, an assessment of T cell recovery and immune response is obtained. Mayo Medical Clinic. http://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/87959. Accessed 17 MARCH 2010 The change from baseline is defined as posttransplant TREC/100,000 CD4+ cells minus pretransplant TREC /100,000 CD4+ cells.

Analysis population: Nine subjects from the LAD-treated arm and 7 subjects from the placebo-treated arm were assessed for TREC per 100,000 CD4+ cells. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.

Groups in this outcome

Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month

Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.

Placebo

Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.

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

Analysis denominator · Participants

GroupSource count
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month9
Placebo7

Reported measurements

Baseline TREC per 100,000 CD4+ cells
Values in TREC /100,000 CD4+ cells · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month67.52447.0863Not reportedNot reportedNot reported
Placebo173.712206.1733Not reportedNot reportedNot reported
Mean change in TREC from baseline to final visit
Values in TREC /100,000 CD4+ cells · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month522.321920.790Not reportedNot reportedNot reported
Placebo-63.950235.561Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Description
    The final on treatment values were included in the analysis.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.125
    statistical Comment
    The statistical method used for a 1-way ANOVA between treatment groups.
    statistical Method
    ANOVA
    tested Non Inferiority
    false
Complete source fields
analyses
  1. group Description
    The final on treatment values were included in the analysis.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.125
    statistical Comment
    The statistical method used for a 1-way ANOVA between treatment groups.
    statistical Method
    ANOVA
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        47.0863
        value
        67.524
      2. group Id
        OG001
        spread
        206.1733
        value
        173.712
    title
    Baseline TREC per 100,000 CD4+ cells
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        920.790
        value
        522.321
      2. group Id
        OG001
        spread
        235.561
        value
        -63.950
    title
    Mean change in TREC from baseline to final visit
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    2. group Id
      OG001
      value
      7
    units
    Participants
description
CD4+ cells are a type of T cell. T cells are produced in the thymus and thymic function can be determined by TREC. By counting the number of TRECs present (only 1 copy per cell) within a population of CD4 cells, an assessment of T cell recovery and immune response is obtained. Mayo Medical Clinic. http://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/87959. Accessed 17 MARCH 2010 The change from baseline is defined as posttransplant TREC/100,000 CD4+ cells minus pretransplant TREC /100,000 CD4+ cells.
dispersion Type
Standard Deviation
groups
  1. description
    Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
    id
    OG000
    title
    Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month
  2. description
    Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
    id
    OG001
    title
    Placebo
param Type
MEAN
population Description
Nine subjects from the LAD-treated arm and 7 subjects from the placebo-treated arm were assessed for TREC per 100,000 CD4+ cells. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.
reporting Status
POSTED
time Frame
Pretransplant and posttransplant (Month 12)
title
Mean Change From Baseline in T Cell Excision Circles (TREC) Per 100,000 CD4+ Cells to Final Visit in Patients Treated With LAD (11.25 mg) or Placebo After Transplant
type
SECONDARY
unit Of Measure
TREC /100,000 CD4+ cells

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Preserved source evidence · Not medical advice