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NCT03112603 · OUTCOME

Rate of Failure-free Survival (FFS)

A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3) · Source last updated 2025-08-12

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Baseline to when the last participant reached Cycle 7 Day 1 (each cycle was comprised of 4 weeks)

What was measured

Composite time to event endpoint incorporating the following FFS events: (i) relapse or recurrence of underlying disease or death due to underlying disease, (ii) nonrelapse mortality, or (iii) addition or initiation of another systemic therapy for cGvHD.

Analysis population: FAS. Data reported are from the start of the study to Cycle 7 Day 1 (data cutoff of 08 May 2020).

Groups in this outcome

Ruxolitinib

Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).

Best Available Therapy

Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.

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

Analysis denominator · Participants

GroupSource count
Ruxolitinib165
Best Available Therapy164

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RuxolitinibNANot reported18.6NAThe median FFS time was not reached due to an insufficient number of participants with events.
Best Available Therapy5.7Not reported5.66.5Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.268
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.510
    estimate Comment
    The hazard ratio was obtained from a stratified Cox model using cGvHD severity at randomization as strata.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    <0.0001
    p Value Comment
    The p-value was derived from a 1-sided stratified log-rank test.
    param Type
    Hazard Ratio (HR)
    param Value
    0.370
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.268
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.510
    estimate Comment
    The hazard ratio was obtained from a stratified Cox model using cGvHD severity at randomization as strata.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    <0.0001
    p Value Comment
    The p-value was derived from a 1-sided stratified log-rank test.
    param Type
    Hazard Ratio (HR)
    param Value
    0.370
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        The median FFS time was not reached due to an insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        18.6
        upper Limit
        NA
        value
        NA
      2. group Id
        OG001
        lower Limit
        5.6
        upper Limit
        6.5
        value
        5.7
denoms
  1. counts
    1. group Id
      OG000
      value
      165
    2. group Id
      OG001
      value
      164
    units
    Participants
description
Composite time to event endpoint incorporating the following FFS events: (i) relapse or recurrence of underlying disease or death due to underlying disease, (ii) nonrelapse mortality, or (iii) addition or initiation of another systemic therapy for cGvHD.
dispersion Type
95% Confidence Interval
groups
  1. description
    Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).
    id
    OG000
    title
    Ruxolitinib
  2. description
    Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.
    id
    OG001
    title
    Best Available Therapy
param Type
MEDIAN
population Description
FAS. Data reported are from the start of the study to Cycle 7 Day 1 (data cutoff of 08 May 2020).
reporting Status
POSTED
time Frame
Baseline to when the last participant reached Cycle 7 Day 1 (each cycle was comprised of 4 weeks)
title
Rate of Failure-free Survival (FFS)
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice