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NCT01300572 · OUTCOME

Estimation of Absorbed Radiation Doses to Normal Organs, Marrow and Tumor

Yttrium-90 Anti-CD45 Monoclonal Antibody BC8 Followed by Donor Stem Cell Transplant in Treating Patients With High-Risk AML, ALL, or MDS · Source last updated 2019-12-10

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
Gy
Interval / dispersion
Standard Deviation
Time frame
Approximately day -20 to day -12 prior to transplant

What was measured

The amount of energy absorbed per unit weight of the organ or tissue is called absorbed dose and is expressed in units of gray (Gy). One gray dose is equivalent to one joule radiation energy absorbed per kilogram of organ or tissue weight.

Analysis population: All study participants who completed the study regimen.

Groups in this outcome

Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)

PREPARATIVE REGIMEN: Patients receive 90Y-BC8 via central line on approximately day -12, fludarabine phosphate IV over 30 minutes on days -4 to -2, and 2 Gy TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSC or bone marrow transplant on day 0. GVHD PROPHYLAXIS: Patients receive mycophenolate mofetil PO or IV every 12 hours on days 0-27 (for patients with related donors) or every 8 hours on days 0-40 with taper to day 96 (for patients with unrelated donors). Patients also receive cyclosporine PO or IV every 12 hours on days -3 to 56 (for patients with related donors) or 100 (for patients with unrelated donors) with taper to day 180. Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or bone marrow transplant Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Indium In 111 Anti-CD45 Monoclonal Antibody BC8: Given IV (dosimetric dose)

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 (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)15

Reported measurements

Average absorbed dose to the marrow
Values in Gy · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)11.49.2Not reportedNot reportedNot reported
Average absorbed dose to the liver
Values in Gy · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)17.26.8Not reportedNot reportedNot reported
Average abosorbed dose total body
Values in Gy · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)3.15.7Not reportedNot reportedNot reported
Average absorbed dose to the spleen
Values in Gy · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)7043Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.2
        value
        11.4
    title
    Average absorbed dose to the marrow
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.8
        value
        17.2
    title
    Average absorbed dose to the liver
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.7
        value
        3.1
    title
    Average abosorbed dose total body
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        43
        value
        70
    title
    Average absorbed dose to the spleen
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    units
    Participants
description
The amount of energy absorbed per unit weight of the organ or tissue is called absorbed dose and is expressed in units of gray (Gy). One gray dose is equivalent to one joule radiation energy absorbed per kilogram of organ or tissue weight.
dispersion Type
Standard Deviation
groups
  1. description
    PREPARATIVE REGIMEN: Patients receive 90Y-BC8 via central line on approximately day -12, fludarabine phosphate IV over 30 minutes on days -4 to -2, and 2 Gy TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSC or bone marrow transplant on day 0. GVHD PROPHYLAXIS: Patients receive mycophenolate mofetil PO or IV every 12 hours on days 0-27 (for patients with related donors) or every 8 hours on days 0-40 with taper to day 96 (for patients with unrelated donors). Patients also receive cyclosporine PO or IV every 12 hours on days -3 to 56 (for patients with related donors) or 100 (for patients with unrelated donors) with taper to day 180. Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or bone marrow transplant Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Indium In 111 Anti-CD45 Monoclonal Antibody BC8: Given IV (dosimetric dose)
    id
    OG000
    title
    Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)
param Type
MEAN
population Description
All study participants who completed the study regimen.
reporting Status
POSTED
time Frame
Approximately day -20 to day -12 prior to transplant
title
Estimation of Absorbed Radiation Doses to Normal Organs, Marrow and Tumor
type
SECONDARY
unit Of Measure
Gy

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

Preserved source evidence · Not medical advice