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NCT02356159 · OUTCOME

Phase II: Estimated Percent of Participants Who Experienced Severe Chronic Graft Versus Host Disease (GVHD)

Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation · Source last updated 2025-09-30

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

Measure
NUMBER
Unit
Estimated percent of participants
Interval / dispersion
95% Confidence Interval
Time frame
60 months

What was measured

The estimated percent of participants who experienced severe chronic graft versus host disease (GVHD) was assessed by the 1994 Consensus Conference Working Criteria. Severe GVHD is defined using the Global Staging per 2014 National Institutes of Health (NIH) Consensus Criteria for chronic GVHD.

Analysis population: The total number of participants analyzed for the primary outcome measure is 19 (16 enrolled on the phase 2 Arm and data/outcomes on the 3 participants from phase 1 treated at dose level 4).

Groups in this outcome

2/Phase II Arm - Palifermin at the Recommended Phase 2 Dose

Induction chemotherapy, then palifermin at the recommended phase 2 dose (RP2D) determined in Phase 1, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.

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

Analysis denominator · Participants

GroupSource count
2/Phase II Arm - Palifermin at the Recommended Phase 2 Dose19

Reported measurements

Source class 1
Values in Estimated percent of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
2/Phase II Arm - Palifermin at the Recommended Phase 2 Dose6.0Not reported0.324.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.3
        upper Limit
        24.7
        value
        6.0
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    units
    Participants
description
The estimated percent of participants who experienced severe chronic graft versus host disease (GVHD) was assessed by the 1994 Consensus Conference Working Criteria. Severe GVHD is defined using the Global Staging per 2014 National Institutes of Health (NIH) Consensus Criteria for chronic GVHD.
dispersion Type
95% Confidence Interval
groups
  1. description
    Induction chemotherapy, then palifermin at the recommended phase 2 dose (RP2D) determined in Phase 1, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
    id
    OG000
    title
    2/Phase II Arm - Palifermin at the Recommended Phase 2 Dose
param Type
NUMBER
population Description
The total number of participants analyzed for the primary outcome measure is 19 (16 enrolled on the phase 2 Arm and data/outcomes on the 3 participants from phase 1 treated at dose level 4).
reporting Status
POSTED
time Frame
60 months
title
Phase II: Estimated Percent of Participants Who Experienced Severe Chronic Graft Versus Host Disease (GVHD)
type
PRIMARY
unit Of Measure
Estimated percent of participants

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

Preserved source evidence · Not medical advice