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NCT01824693 · OUTCOME

Number of Participants Who Experience Treatment-Related Mortality (TRM) by Day 100

Busulfan, Cyclophosphamide, and Melphalan or Busulfan and Fludarabine Phosphate Before Donor Hematopoietic Cell Transplant in Treating Younger Patients With Juvenile Myelomonocytic Leukemia · Source last updated 2018-12-05

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
From transplant up to 100 days

What was measured

The number of patients who experience TRM on day 100. Treatment-Related Mortality (TRM) an event defined as a death prior to relapse or non-response. Time to TRM is defined as time from transplants to TRM. Patients who die between the start of the conditioning regimen and transplant will be considered a TRM with time to TRM of zero.

Analysis population: All eligible randomized patients

Groups in this outcome

Arm I (Busulfan, Cyclophosphamide, Melphalan)

CONDITIONING REGIMEN: Patients receive busulfan IV QD, every 12 hours, or every 6 hours over 2-3 hours on days -8 to -5, cyclophosphamide IV QD over 60 minutes on days -4 and -3, and melphalan IV over 15-30 minutes on day -1. TRANSPLANT: Patients undergo allogeneic HCT no sooner than 24 hours after the last dose of chemotherapy. Patients receive tacrolimus IV or PO on days -1 to 98 (related donor) or 180 (unrelated donor) and mycophenolate mofetil IV over 2 hours or PO every 8 hours on days 1-30 (related donor) or 45 (unrelated donor). Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic HCT Busulfan: Given IV Cyclophosphamide: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given IV or PO Pharmacological Study: Correlative studies Tacrolimus: Given IV or PO

Arm II (Busulfan, Fludarabine Phosphate)

CONDITIONING REGIMEN: Patients receive busulfan as in Arm I and fludarabine phosphate IV over 1 hour on days -5 to -2. TRANSPLANT: Patients undergo allogeneic HCT as in Arm I. Patients receive tacrolimus IV or PO on days -1 to 98 (related donor) or 180 (unrelated donor) and mycophenolate mofetil IV over 2 hours or PO every 8 hours on days 1-30 (related donor) or 45 (unrelated donor). Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic HCT Busulfan: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Pharmacological Study: Correlative studies Tacrolimus: Given IV or PO

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

Analysis denominator · Participants

GroupSource count
Arm I (Busulfan, Cyclophosphamide, Melphalan)6
Arm II (Busulfan, Fludarabine Phosphate)9

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Busulfan, Cyclophosphamide, Melphalan)0Not reportedNot reportedNot reportedNot reported
Arm II (Busulfan, Fludarabine Phosphate)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      9
    units
    Participants
description
The number of patients who experience TRM on day 100. Treatment-Related Mortality (TRM) an event defined as a death prior to relapse or non-response. Time to TRM is defined as time from transplants to TRM. Patients who die between the start of the conditioning regimen and transplant will be considered a TRM with time to TRM of zero.
groups
  1. description
    CONDITIONING REGIMEN: Patients receive busulfan IV QD, every 12 hours, or every 6 hours over 2-3 hours on days -8 to -5, cyclophosphamide IV QD over 60 minutes on days -4 and -3, and melphalan IV over 15-30 minutes on day -1. TRANSPLANT: Patients undergo allogeneic HCT no sooner than 24 hours after the last dose of chemotherapy. Patients receive tacrolimus IV or PO on days -1 to 98 (related donor) or 180 (unrelated donor) and mycophenolate mofetil IV over 2 hours or PO every 8 hours on days 1-30 (related donor) or 45 (unrelated donor). Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic HCT Busulfan: Given IV Cyclophosphamide: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given IV or PO Pharmacological Study: Correlative studies Tacrolimus: Given IV or PO
    id
    OG000
    title
    Arm I (Busulfan, Cyclophosphamide, Melphalan)
  2. description
    CONDITIONING REGIMEN: Patients receive busulfan as in Arm I and fludarabine phosphate IV over 1 hour on days -5 to -2. TRANSPLANT: Patients undergo allogeneic HCT as in Arm I. Patients receive tacrolimus IV or PO on days -1 to 98 (related donor) or 180 (unrelated donor) and mycophenolate mofetil IV over 2 hours or PO every 8 hours on days 1-30 (related donor) or 45 (unrelated donor). Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic HCT Busulfan: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Pharmacological Study: Correlative studies Tacrolimus: Given IV or PO
    id
    OG001
    title
    Arm II (Busulfan, Fludarabine Phosphate)
param Type
COUNT_OF_PARTICIPANTS
population Description
All eligible randomized patients
reporting Status
POSTED
time Frame
From transplant up to 100 days
title
Number of Participants Who Experience Treatment-Related Mortality (TRM) by Day 100
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice