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NCT01350258 · OUTCOME

GVHD Incidence and Severity

Bone Marrow Transplant Using a Reduced Intensity Regimen That is Given in Two Steps · Source last updated 2025-05-31

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
At 1 and 3 years

What was measured

To determine the incidence and severity of graft-versus-host disease (GVHD) in patients undergoing treatment on this regimen using MEL for T cell tolerization as well as tacrolimus and mycophenolate mofetil (MMF) as GVHD prophylaxis.

Groups in this outcome

Transplant Treatment Group

REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2. TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28.

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

Analysis denominator · Participants

GroupSource count
Transplant Treatment Group0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
To determine the incidence and severity of graft-versus-host disease (GVHD) in patients undergoing treatment on this regimen using MEL for T cell tolerization as well as tacrolimus and mycophenolate mofetil (MMF) as GVHD prophylaxis.
groups
  1. description
    REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2. TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28.
    id
    OG000
    title
    Transplant Treatment Group
reporting Status
POSTED
time Frame
At 1 and 3 years
title
GVHD Incidence and Severity
type
SECONDARY

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

Preserved source evidence · Not medical advice