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NCT00860574 · OUTCOME

Non Relapse Mortality (NRM) Incidence

Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia · Source last updated 2021-06-22

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
At 6 months

What was measured

Cumulative incidence of NRM at 6 months. NRM includes all deaths without relapse or disease progression.

Groups in this outcome

Treatment (Allogeneic Transplantation)

CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11. treosulfan: Given IV fludarabine phosphate: Given IV total-body irradiation: Low dose starting at 2Gy peripheral blood stem cell transplantation: Given IV per institutional standard practice tacrolimus: Given IV or PO allogeneic bone marrow transplantation: Given IV per institutional standard practice allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice methotrexate: Given IV

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 (Allogeneic Transplantation)96

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Allogeneic Transplantation)6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
denoms
  1. counts
    1. group Id
      OG000
      value
      96
    units
    Participants
description
Cumulative incidence of NRM at 6 months. NRM includes all deaths without relapse or disease progression.
groups
  1. description
    CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11. treosulfan: Given IV fludarabine phosphate: Given IV total-body irradiation: Low dose starting at 2Gy peripheral blood stem cell transplantation: Given IV per institutional standard practice tacrolimus: Given IV or PO allogeneic bone marrow transplantation: Given IV per institutional standard practice allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice methotrexate: Given IV
    id
    OG000
    title
    Treatment (Allogeneic Transplantation)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
At 6 months
title
Non Relapse Mortality (NRM) Incidence
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice