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NCT01408043 · OUTCOME

Need for Remobilization

Etoposide, Filgrastim, and Plerixafor in Improving Stem Cell Mobilization in Treating Patients With Non-Hodgkin Lymphoma · Source last updated 2019-06-14

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
Up to 28 days post treatment

What was measured

Number of participants that needed remobilization in supermobilizers and normal mobilizers. Remobilization can be described as follows: The first step for patients undergoing autologous hematopoietic cell transplantation is to mobilize hematopoietic progenitor/stem cells from the bone marrow using G-CSF, plerixafor and/or chemotherapy. This is followed by collection of the cells by apheresis. If sufficient number of progenitor/stem cells cannot be mobilized and then collected by apheresis to proceed with transplantation, it is considered as "mobilization failure". For these patients, mobilization of their hematopoietic progenitor/stem cells is attempted a second time ("remobilization"). The need to do a second 'mobilization' attempt is not ideal.

Analysis population: Participants that were mobilized

Groups in this outcome

Treatment (Stem Cell Supermobilization)

Patients receive etoposide IV over 4 hours on day 0, filgrastim SC QD beginning day 1, and plerixafor SC 15-18 hours prior to apheresis. Patients unable to achieve target collection of \>= 8 x 10\^6 CD34+ cells/kg receive another dose of plerixafor followed by apheresis. Following the second apheresis, patients achieving =\< 2 x 10\^6 CD34+ cells/kg may continue filgrastim with plerixafor and continue collection according to the attending physician. plerixafor: Given SC filgrastim: Given SC etoposide: Given IV leukapheresis: Undergo apheresis

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

Analysis denominator · Participants

GroupSource count
Treatment (Stem Cell Supermobilization)24

Reported measurements

Supermobilizers

Analysis denominator · Participants

GroupSource count
Treatment (Stem Cell Supermobilization)7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Stem Cell Supermobilization)0Not reportedNot reportedNot reportedNot reported
Normal Mobilizers

Analysis denominator · Participants

GroupSource count
Treatment (Stem Cell Supermobilization)17
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Stem Cell Supermobilization)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    Supermobilizers
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      units
      Participants
    title
    Normal Mobilizers
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    units
    Participants
description
Number of participants that needed remobilization in supermobilizers and normal mobilizers. Remobilization can be described as follows: The first step for patients undergoing autologous hematopoietic cell transplantation is to mobilize hematopoietic progenitor/stem cells from the bone marrow using G-CSF, plerixafor and/or chemotherapy. This is followed by collection of the cells by apheresis. If sufficient number of progenitor/stem cells cannot be mobilized and then collected by apheresis to proceed with transplantation, it is considered as "mobilization failure". For these patients, mobilization of their hematopoietic progenitor/stem cells is attempted a second time ("remobilization"). The need to do a second 'mobilization' attempt is not ideal.
groups
  1. description
    Patients receive etoposide IV over 4 hours on day 0, filgrastim SC QD beginning day 1, and plerixafor SC 15-18 hours prior to apheresis. Patients unable to achieve target collection of \>= 8 x 10\^6 CD34+ cells/kg receive another dose of plerixafor followed by apheresis. Following the second apheresis, patients achieving =\< 2 x 10\^6 CD34+ cells/kg may continue filgrastim with plerixafor and continue collection according to the attending physician. plerixafor: Given SC filgrastim: Given SC etoposide: Given IV leukapheresis: Undergo apheresis
    id
    OG000
    title
    Treatment (Stem Cell Supermobilization)
param Type
COUNT_OF_PARTICIPANTS
population Description
Participants that were mobilized
reporting Status
POSTED
time Frame
Up to 28 days post treatment
title
Need for Remobilization
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice