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NCT00445744 · OUTCOME

Effectiveness of Cyclophosphamide/Busulfan Regimen in Reducing Regimen-related Liver Toxicity

Cyclophosphamide and Busulfan Followed by Donor Stem Cell Transplant in Treating Patients With Myelofibrosis, Acute Myeloid Leukemia, or Myelodysplastic Syndrome · Source last updated 2018-01-02

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
Up to day +20

What was measured

Number of patients with regimen-related liver toxicity. Diagnoses will be made according to the established criteria initially proposed in 1984 by McDonald et al.

Groups in this outcome

Treatment (Cyclophosphamide, Busulfan, Transplant)

CONDITIONING REGIMEN: Patients receive cyclophosphamide IV on days -7 and -6 and busulfan IV over 3 hours on days -5 to -2. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplant on day 0. POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive tacrolimus IV or PO twice daily on days -1 to 200 with taper on day 56 and methotrexate on days 1, 3, 6, and 11. cyclophosphamide: Given IV busulfan: Given IV tacrolimus: Given IV or PO methotrexate: Given IV cytogenetic analysis: Correlative studies flow cytometry: Correlative studies pharmacological study: Correlative studies pharmacogenomic studies: Correlative studies peripheral blood stem cell transplantation: Undergo PBPC transplantation allogeneic hematopoietic stem cell transplantation: Undergo allogeneic transplantation

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 (Cyclophosphamide, Busulfan, Transplant)51

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Cyclophosphamide, Busulfan, Transplant)8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8
denoms
  1. counts
    1. group Id
      OG000
      value
      51
    units
    Participants
description
Number of patients with regimen-related liver toxicity. Diagnoses will be made according to the established criteria initially proposed in 1984 by McDonald et al.
groups
  1. description
    CONDITIONING REGIMEN: Patients receive cyclophosphamide IV on days -7 and -6 and busulfan IV over 3 hours on days -5 to -2. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplant on day 0. POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive tacrolimus IV or PO twice daily on days -1 to 200 with taper on day 56 and methotrexate on days 1, 3, 6, and 11. cyclophosphamide: Given IV busulfan: Given IV tacrolimus: Given IV or PO methotrexate: Given IV cytogenetic analysis: Correlative studies flow cytometry: Correlative studies pharmacological study: Correlative studies pharmacogenomic studies: Correlative studies peripheral blood stem cell transplantation: Undergo PBPC transplantation allogeneic hematopoietic stem cell transplantation: Undergo allogeneic transplantation
    id
    OG000
    title
    Treatment (Cyclophosphamide, Busulfan, Transplant)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to day +20
title
Effectiveness of Cyclophosphamide/Busulfan Regimen in Reducing Regimen-related Liver Toxicity
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice