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NCT00899847 · OUTCOME

Median Time to Engraftment After Allo-PBSC Transplant

Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using TLI & ATG · Source last updated 2017-10-20

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
1 month

What was measured

Engraftment is assessed as: * Neutrophil engraftment is \> 0.5 x 10⁹/L after cytopenia * Platelet engraftment is \> 20 x 10⁹/L after cytopenia

Analysis population: Due to the less intensive conditioning before allo-PBSC, only 2 participants experienced cytopenia, and thus only 2 participants could be evaluated for engraftment after allo-PBSC.

Groups in this outcome

Autologous-Allogeneic Hematopoietic Stem Cell Transplant

Study treatment is a high-dose sequential chemotherapy approach to hematopoietic stem cell (HSC) transplant that uses an autologous peripheral blood stem cell (auto-PBSC) transplant followed by allogeneic peripheral blood stem cell (allo-PBSC) transplant to evaluate improved graft vs host disease (GvHD) control. Participant auto-PBSC are mobilized with cyclophosphamide (also to provide cytoreduction) and filgrastim, followed by melphalan as an auto-PBSC conditioning agent, then auto-PBSC infusion. For the allo-PBSC transplant, donors are mobilized with filgrastim, and participants receive a regimen of total lymphoid irradiation and anti-thymocyte globulin (TLI/ATG), followed by infusion of donor allo-PBSC. Solumedrol, diphenhydramine, acetaminophen, and hydrocortisone are administered as premedications, and rabbit anti-thymocyte globulin (ATG) plus mycophenolate mofetil (MMF) are administered for post-allo-PBSC immunosuppression.

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

Analysis denominator · Participants

GroupSource count
Autologous-Allogeneic Hematopoietic Stem Cell Transplant2

Reported measurements

Neutrophil Engraftment
Values in Days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Autologous-Allogeneic Hematopoietic Stem Cell Transplant24Not reported2424Not reported
Platelet Engraftment
Values in Days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Autologous-Allogeneic Hematopoietic Stem Cell Transplant10Not reported1010Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        24
        upper Limit
        24
        value
        24
    title
    Neutrophil Engraftment
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10
        upper Limit
        10
        value
        10
    title
    Platelet Engraftment
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    units
    Participants
description
Engraftment is assessed as: * Neutrophil engraftment is \> 0.5 x 10⁹/L after cytopenia * Platelet engraftment is \> 20 x 10⁹/L after cytopenia
dispersion Type
Full Range
groups
  1. description
    Study treatment is a high-dose sequential chemotherapy approach to hematopoietic stem cell (HSC) transplant that uses an autologous peripheral blood stem cell (auto-PBSC) transplant followed by allogeneic peripheral blood stem cell (allo-PBSC) transplant to evaluate improved graft vs host disease (GvHD) control. Participant auto-PBSC are mobilized with cyclophosphamide (also to provide cytoreduction) and filgrastim, followed by melphalan as an auto-PBSC conditioning agent, then auto-PBSC infusion. For the allo-PBSC transplant, donors are mobilized with filgrastim, and participants receive a regimen of total lymphoid irradiation and anti-thymocyte globulin (TLI/ATG), followed by infusion of donor allo-PBSC. Solumedrol, diphenhydramine, acetaminophen, and hydrocortisone are administered as premedications, and rabbit anti-thymocyte globulin (ATG) plus mycophenolate mofetil (MMF) are administered for post-allo-PBSC immunosuppression.
    id
    OG000
    title
    Autologous-Allogeneic Hematopoietic Stem Cell Transplant
param Type
MEDIAN
population Description
Due to the less intensive conditioning before allo-PBSC, only 2 participants experienced cytopenia, and thus only 2 participants could be evaluated for engraftment after allo-PBSC.
reporting Status
POSTED
time Frame
1 month
title
Median Time to Engraftment After Allo-PBSC Transplant
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice