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NCT01300572 · OUTCOME

Rates of Non-relapse Mortality

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Within the first 100 days following transplant

What was measured

Transplant-related deaths within 100 days after transplant

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

Severe refractory GVHD
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)1Not reportedNot reportedNot reportedNot reported
Bacterial infection
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Severe refractory GVHD
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Bacterial infection
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    units
    Participants
description
Transplant-related deaths within 100 days after transplant
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
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Within the first 100 days following transplant
title
Rates of Non-relapse Mortality
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice