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NCT01824693 · OUTCOME

Percent Probability of 18 Months-relapse Event Between Arms

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
NUMBER
Unit
percent probability
Interval / dispersion
95% Confidence Interval
Time frame
From transplant up to 18 months

What was measured

Probability of patients relapsing at 18 months. A relapse event is defined in protocol section 10.2.3. Time to relapse/non-response is defined as time from transplant to when all criteria of section 10.2.3 are met.

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 percent probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Busulfan, Cyclophosphamide, Melphalan)17Not reported0.455Not reported
Arm II (Busulfan, Fludarabine Phosphate)55Not reported1683Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.4
        upper Limit
        55
        value
        17
      2. group Id
        OG001
        lower Limit
        16
        upper Limit
        83
        value
        55
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      9
    units
    Participants
description
Probability of patients relapsing at 18 months. A relapse event is defined in protocol section 10.2.3. Time to relapse/non-response is defined as time from transplant to when all criteria of section 10.2.3 are met.
dispersion Type
95% Confidence Interval
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
NUMBER
population Description
All eligible randomized patients
reporting Status
POSTED
time Frame
From transplant up to 18 months
title
Percent Probability of 18 Months-relapse Event Between Arms
type
SECONDARY
unit Of Measure
percent probability

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

Preserved source evidence · Not medical advice