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NCT03112603 · OUTCOME

Cumulative Incidence of Malignancy Relapse/Recurrence (MR)

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Months 3, 6, 12, 18, 24, 30, and 36

What was measured

Defined as the cumulative incidence rate from competing risk analysis of MR from the date of randomization to hematologic malignancy relapse/recurrence.

Analysis population: FAS. Cumulative incidence was calculated for participants with underlying hematologic malignant disease. Only participants with available data were analyzed.

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
Ruxolitinib156
Best Available Therapy160

Reported measurements

0 to < 3 months

Analysis denominator · Participants

GroupSource count
Ruxolitinib156
Best Available Therapy160
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib1.92Not reported0.525.12Not reported
Best Available Therapy1.31Not reported0.264.27Not reported
3 to < 6 months

Analysis denominator · Participants

GroupSource count
Ruxolitinib143
Best Available Therapy142
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib3.22Not reported1.206.93Not reported
Best Available Therapy2.65Not reported0.876.21Not reported
6 to < 12 months

Analysis denominator · Participants

GroupSource count
Ruxolitinib134
Best Available Therapy133
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib5.18Not reported2.429.49Not reported
Best Available Therapy6.08Not reported2.9810.73Not reported
12 to < 18 months

Analysis denominator · Participants

GroupSource count
Ruxolitinib121
Best Available Therapy114
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib7.82Not reported4.2512.77Not reported
Best Available Therapy6.08Not reported2.9810.73Not reported
18 to < 24 months

Analysis denominator · Participants

GroupSource count
Ruxolitinib115
Best Available Therapy110
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib8.48Not reported4.7413.57Not reported
Best Available Therapy6.08Not reported2.9810.73Not reported
24 to <30 months

Analysis denominator · Participants

GroupSource count
Ruxolitinib111
Best Available Therapy105
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib8.48Not reported4.7413.57Not reported
Best Available Therapy6.78Not reported3.4611.62Not reported
30 to <36 months

Analysis denominator · Participants

GroupSource count
Ruxolitinib108
Best Available Therapy102
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib8.48Not reported4.7413.57Not reported
Best Available Therapy7.50Not reported3.9612.52Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.52
        upper Limit
        5.12
        value
        1.92
      2. group Id
        OG001
        lower Limit
        0.26
        upper Limit
        4.27
        value
        1.31
    denoms
    1. counts
      1. group Id
        OG000
        value
        156
      2. group Id
        OG001
        value
        160
      units
      Participants
    title
    0 to < 3 months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.20
        upper Limit
        6.93
        value
        3.22
      2. group Id
        OG001
        lower Limit
        0.87
        upper Limit
        6.21
        value
        2.65
    denoms
    1. counts
      1. group Id
        OG000
        value
        143
      2. group Id
        OG001
        value
        142
      units
      Participants
    title
    3 to < 6 months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.42
        upper Limit
        9.49
        value
        5.18
      2. group Id
        OG001
        lower Limit
        2.98
        upper Limit
        10.73
        value
        6.08
    denoms
    1. counts
      1. group Id
        OG000
        value
        134
      2. group Id
        OG001
        value
        133
      units
      Participants
    title
    6 to < 12 months
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.25
        upper Limit
        12.77
        value
        7.82
      2. group Id
        OG001
        lower Limit
        2.98
        upper Limit
        10.73
        value
        6.08
    denoms
    1. counts
      1. group Id
        OG000
        value
        121
      2. group Id
        OG001
        value
        114
      units
      Participants
    title
    12 to < 18 months
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.74
        upper Limit
        13.57
        value
        8.48
      2. group Id
        OG001
        lower Limit
        2.98
        upper Limit
        10.73
        value
        6.08
    denoms
    1. counts
      1. group Id
        OG000
        value
        115
      2. group Id
        OG001
        value
        110
      units
      Participants
    title
    18 to < 24 months
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.74
        upper Limit
        13.57
        value
        8.48
      2. group Id
        OG001
        lower Limit
        3.46
        upper Limit
        11.62
        value
        6.78
    denoms
    1. counts
      1. group Id
        OG000
        value
        111
      2. group Id
        OG001
        value
        105
      units
      Participants
    title
    24 to <30 months
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.74
        upper Limit
        13.57
        value
        8.48
      2. group Id
        OG001
        lower Limit
        3.96
        upper Limit
        12.52
        value
        7.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        108
      2. group Id
        OG001
        value
        102
      units
      Participants
    title
    30 to <36 months
denoms
  1. counts
    1. group Id
      OG000
      value
      156
    2. group Id
      OG001
      value
      160
    units
    Participants
description
Defined as the cumulative incidence rate from competing risk analysis of MR from the date of randomization to hematologic malignancy relapse/recurrence.
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
NUMBER
population Description
FAS. Cumulative incidence was calculated for participants with underlying hematologic malignant disease. Only participants with available data were analyzed.
reporting Status
POSTED
time Frame
Months 3, 6, 12, 18, 24, 30, and 36
title
Cumulative Incidence of Malignancy Relapse/Recurrence (MR)
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice