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NCT00432094 · OUTCOME

Numbers of Patients Unable to Mobilize Peripheral Blood Stem Cells

Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors · Source last updated 2022-05-17

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
Pre-Transplant

What was measured

Number of patients unable to achieve adequate stem cell mobilization, need to undergo one or tandem transplantation. Stem cell mobilization = A process in which certain drugs are used to cause the movement of stem cells from the bone marrow into the blood. The stem cells can be collected and stored. They may be used later to replace the bone marrow during a stem cell transplant.

Analysis population: The protocol is essentially one single-arm, but patients received either one or two transplants depending on the cells they had available and we are reporting results for these two groups.

Groups in this outcome

2 Transplants

Patients with Germ Cell Tumors (GCT) treated with a second tandem autologous stem cell transplant (AuSCT) with non-cross-resistant conditioning regimens. carboplatin: Days -6, -5, -4: 500mg/m2\^/day intravenously (IV) over 60 minutes etoposide: 600mg/m\^2/day intravenously (IV) over 60 minutes on Days -6 through -3. thiotepa: 150mg/m\^2/day intravenously IV over 30 minutes; Days -6, -5 and -4 autologous hematopoietic stem cell transplantation: Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg) filgrastim: Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.

1 Transplant

Patients with Germ cell tumors who receive one transplant only. ifosfamide: 2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4. paclitaxel: 225 mg/m\^2 intravenous over 3 hours on Day -7. autologous hematopoietic stem cell transplantation: Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg) Mesna: 2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4. filgrastim: Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.

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

Analysis denominator · Participants

GroupSource count
2 Transplants14
1 Transplant9

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
2 Transplants0Not reportedNot reportedNot reportedNot reported
1 Transplant0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    2. group Id
      OG001
      value
      9
    units
    Participants
description
Number of patients unable to achieve adequate stem cell mobilization, need to undergo one or tandem transplantation. Stem cell mobilization = A process in which certain drugs are used to cause the movement of stem cells from the bone marrow into the blood. The stem cells can be collected and stored. They may be used later to replace the bone marrow during a stem cell transplant.
groups
  1. description
    Patients with Germ Cell Tumors (GCT) treated with a second tandem autologous stem cell transplant (AuSCT) with non-cross-resistant conditioning regimens. carboplatin: Days -6, -5, -4: 500mg/m2\^/day intravenously (IV) over 60 minutes etoposide: 600mg/m\^2/day intravenously (IV) over 60 minutes on Days -6 through -3. thiotepa: 150mg/m\^2/day intravenously IV over 30 minutes; Days -6, -5 and -4 autologous hematopoietic stem cell transplantation: Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg) filgrastim: Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.
    id
    OG000
    title
    2 Transplants
  2. description
    Patients with Germ cell tumors who receive one transplant only. ifosfamide: 2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4. paclitaxel: 225 mg/m\^2 intravenous over 3 hours on Day -7. autologous hematopoietic stem cell transplantation: Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg) Mesna: 2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4. filgrastim: Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.
    id
    OG001
    title
    1 Transplant
param Type
COUNT_OF_PARTICIPANTS
population Description
The protocol is essentially one single-arm, but patients received either one or two transplants depending on the cells they had available and we are reporting results for these two groups.
reporting Status
POSTED
time Frame
Pre-Transplant
title
Numbers of Patients Unable to Mobilize Peripheral Blood Stem Cells
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice