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NCT00396331 · OUTCOME

Number of Participants With Durable Engraftment 12 Months After Autologous Transplantation

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
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Approximately 13 months (12 months post transplant )

What was measured

The number of participants maintaining a durable graft 12 months after transplantation. A durable graft was defined as maintenance of normal blood counts: PLT \>50\*10\^9/L without transfusion for at least 2 weeks prior to the visit; hemoglobin level \>= 10 g/dL with no erythropoietin or transfusions for at least 1 month prior to the visit; and absolute neutrophil count (ANC) \> 1,000 (1\*10\^9/L) with no G-CSF for at least 1 week prior to the visit.

Analysis population: Participants who received autologous stem cell transplantation and were evaluable 12 months post transplant. The 3 participants who did not have durable grafts included 2 participants whose PLT level never recovered to \>50\*10\^9/L and 1 who had low hemoglobin at the 12-month visit.

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 Lymphoma46
Hodgkin's Disease14
Multiple Myeloma8
Other Cancers0
All Patients68

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Non-Hodgkin's Lymphoma44Not reportedNot reportedNot reportedNot reported
Hodgkin's Disease14Not reportedNot reportedNot reportedNot reported
Multiple Myeloma7Not reportedNot reportedNot reportedNot reported
All Patients65Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        44
      2. group Id
        OG001
        value
        14
      3. group Id
        OG002
        value
        7
      4. group Id
        OG004
        value
        65
denoms
  1. counts
    1. group Id
      OG000
      value
      46
    2. group Id
      OG001
      value
      14
    3. group Id
      OG002
      value
      8
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      68
    units
    Participants
description
The number of participants maintaining a durable graft 12 months after transplantation. A durable graft was defined as maintenance of normal blood counts: PLT \>50\*10\^9/L without transfusion for at least 2 weeks prior to the visit; hemoglobin level \>= 10 g/dL with no erythropoietin or transfusions for at least 1 month prior to the visit; and absolute neutrophil count (ANC) \> 1,000 (1\*10\^9/L) with no G-CSF for at least 1 week prior to the visit.
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
NUMBER
population Description
Participants who received autologous stem cell transplantation and were evaluable 12 months post transplant. The 3 participants who did not have durable grafts included 2 participants whose PLT level never recovered to \>50\*10\^9/L and 1 who had low hemoglobin at the 12-month visit.
reporting Status
POSTED
time Frame
Approximately 13 months (12 months post transplant )
title
Number of Participants With Durable Engraftment 12 Months After Autologous Transplantation
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice