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NCT00396331 · OUTCOME

Median Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment

AMD3100 (Plerixafor) With G-CSF in Poor Mobilizing Adult Patients Who Previously Failed Hematopoietic Stem Cell (HSC) Collection/Attempts · Source last updated 2014-03-13

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
approximately 2 months (1 month post transplant)

What was measured

The number of days from transplantation to successful engraftment as measured by PMN \>=0.5\*10\^9 /L for 3 days or \>=1.0\*10\^9 /L for 1 day.

Analysis population: Participants who received a transplant and had a successful PMN engraftment. Seven participants (4 with HD, 2 with MM, and 1 with testicular cancer) received a second transplant. Two transplants (1 in a participant with NHL and 1 in a participant with MM) did not result in PMN engraftment and are therefore not included in the analysis.

Groups in this outcome

Non-Hodgkin's Lymphoma

Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2\*10\^6 CD34+ cells/kg were collected.

Hodgkin's Disease

Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2\*10\^6 CD34+ cells/kg were collected.

Multiple Myeloma

Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2\*10\^6 CD34+ cells/kg were collected.

Other Cancers

Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2\*10\^6 CD34+ cells/kg were collected.

All Patients

Not reported

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

Analysis denominator · Participants

GroupSource count
Non-Hodgkin's Lymphoma60
Hodgkin's Disease16
Multiple Myeloma8
Other Cancers1
All Patients85

Analysis denominator · Transplants with PMN engraftment

GroupSource count
Non-Hodgkin's Lymphoma60
Hodgkin's Disease20
Multiple Myeloma10
Other Cancers2
All Patients92

Reported measurements

Source class 1
Values in Days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Non-Hodgkin's Lymphoma12.0Not reported2.019.0Not reported
Hodgkin's Disease12.0Not reported11.015.0Not reported
Multiple Myeloma13.0Not reported9.016.0Not reported
Other Cancers10.0Not reported7.013.0Not reported
All Patients12.0Not reported2.019.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.0
        upper Limit
        19.0
        value
        12.0
      2. group Id
        OG001
        lower Limit
        11.0
        upper Limit
        15.0
        value
        12.0
      3. group Id
        OG002
        lower Limit
        9.0
        upper Limit
        16.0
        value
        13.0
      4. group Id
        OG003
        lower Limit
        7.0
        upper Limit
        13.0
        value
        10.0
      5. group Id
        OG004
        lower Limit
        2.0
        upper Limit
        19.0
        value
        12.0
denom Units Selected
Participants
denoms
  1. counts
    1. group Id
      OG000
      value
      60
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      8
    4. group Id
      OG003
      value
      1
    5. group Id
      OG004
      value
      85
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      60
    2. group Id
      OG001
      value
      20
    3. group Id
      OG002
      value
      10
    4. group Id
      OG003
      value
      2
    5. group Id
      OG004
      value
      92
    units
    Transplants with PMN engraftment
description
The number of days from transplantation to successful engraftment as measured by PMN \>=0.5\*10\^9 /L for 3 days or \>=1.0\*10\^9 /L for 1 day.
dispersion Type
Full Range
groups
  1. description
    Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2\*10\^6 CD34+ cells/kg were collected.
    id
    OG000
    title
    Non-Hodgkin's Lymphoma
  2. description
    Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2\*10\^6 CD34+ cells/kg were collected.
    id
    OG001
    title
    Hodgkin's Disease
  3. description
    Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2\*10\^6 CD34+ cells/kg were collected.
    id
    OG002
    title
    Multiple Myeloma
  4. description
    Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2\*10\^6 CD34+ cells/kg were collected.
    id
    OG003
    title
    Other Cancers
  5. id
    OG004
    title
    All Patients
param Type
MEDIAN
population Description
Participants who received a transplant and had a successful PMN engraftment. Seven participants (4 with HD, 2 with MM, and 1 with testicular cancer) received a second transplant. Two transplants (1 in a participant with NHL and 1 in a participant with MM) did not result in PMN engraftment and are therefore not included in the analysis.
reporting Status
POSTED
time Frame
approximately 2 months (1 month post transplant)
title
Median Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment
type
SECONDARY
type Units Analyzed
Transplants with PMN engraftment
unit Of Measure
Days

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

Preserved source evidence · Not medical advice