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NCT01338987 · OUTCOME

Time to Engraftment in First Transplant Recipients Only With Median Thoracic Spine Standardized Uptake Values (SUV) of 1.4 or Greater Than Those Patients With SUV's Less Than 1.4

Pilot Study of Leuprolide to Improve Immune Function After Allogeneic Bone Marrow Transplantation · Source last updated 2021-03-18

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

Measure
MEDIAN
Unit
Days
Interval / dispersion
Full Range
Time frame
18F FLT scan done between days +5 to +12 and then time from that scan to engraftment measured

What was measured

18F-FLT imaging was performed serially on patients post transplant to identify the level of uptake of 18F-FLT at a day +5 to +12 scan and the day at which neutrophils recover to \>500 (i.e., subclinical bone-marrow recovery within 5 days of Bone Marrow Transplantation (BMT infusion)). On each image for each patient, the region of interest was drawn within each thoracic medullary space (n=12), generating the SUV for each space. The mean of these was calculated for each scan. The analysis was the median of the means of the SUV of the thorax values of the day 5-12 scan (averaged the SUV of the thorax for each patient and then took the medians of these).

Analysis population: The pre-specified cohort for this endpoint was 23 first BMT recipients. Only 20 of 23 were evaluable due to inability to obtain the early scan (1) or early relapse (2). As pre-specified in the protocol, all 20 patients were analyzed together as the intention was to look at the imaging modality itself and not any effect of leuprolide.

Groups in this outcome

Transplant Recipient

Patients receiving first allogeneic bone marrow transplant on this study.

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

Analysis denominator · Participants

GroupSource count
Transplant Recipient20

Reported measurements

Patients with SUV 1.4 or greater

Analysis denominator · Participants

GroupSource count
Transplant Recipient5
Values in Days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Transplant Recipient5Not reported313Not reported
Patients with SUV less than 1.4

Analysis denominator · Participants

GroupSource count
Transplant Recipient15
Values in Days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Transplant Recipient15Not reported822Not reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.0075
    statistical Method
    Wilcoxon's rank sum test
Complete source fields
analyses
  1. group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.0075
    statistical Method
    Wilcoxon's rank sum test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3
        upper Limit
        13
        value
        5
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    Patients with SUV 1.4 or greater
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8
        upper Limit
        22
        value
        15
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      units
      Participants
    title
    Patients with SUV less than 1.4
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    units
    Participants
description
18F-FLT imaging was performed serially on patients post transplant to identify the level of uptake of 18F-FLT at a day +5 to +12 scan and the day at which neutrophils recover to \>500 (i.e., subclinical bone-marrow recovery within 5 days of Bone Marrow Transplantation (BMT infusion)). On each image for each patient, the region of interest was drawn within each thoracic medullary space (n=12), generating the SUV for each space. The mean of these was calculated for each scan. The analysis was the median of the means of the SUV of the thorax values of the day 5-12 scan (averaged the SUV of the thorax for each patient and then took the medians of these).
dispersion Type
Full Range
groups
  1. description
    Patients receiving first allogeneic bone marrow transplant on this study.
    id
    OG000
    title
    Transplant Recipient
param Type
MEDIAN
population Description
The pre-specified cohort for this endpoint was 23 first BMT recipients. Only 20 of 23 were evaluable due to inability to obtain the early scan (1) or early relapse (2). As pre-specified in the protocol, all 20 patients were analyzed together as the intention was to look at the imaging modality itself and not any effect of leuprolide.
reporting Status
POSTED
time Frame
18F FLT scan done between days +5 to +12 and then time from that scan to engraftment measured
title
Time to Engraftment in First Transplant Recipients Only With Median Thoracic Spine Standardized Uptake Values (SUV) of 1.4 or Greater Than Those Patients With SUV's Less Than 1.4
type
PRIMARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice