NCT04191187 · OUTCOME

Disease Free Survival

Reduced Intensity Flu/Mel/TBI Conditioning for HAPLO HCT Patients With Hematologic Malignancies · Source last updated 2025-12-11

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: 90% Confidence Interval
Time frame: Up to 18 months post-transplant

What was measured

Disease Free Survival (DFS) is defined as the time from the date of Peripheral Blood Stem Cell Transplant (PBSCT) to first documentation of relapse or death due to any cause, whichever comes first.

Analysis population: Evaluable Participants

Groups in this outcome

Conditioning Regimen + Transplant

All participants will receive a conditioning regimen of Fludarabine, Melphalan and Total Body Irradiation prior to transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT) Fludarabine: Fludarabine 30mg/m\^2/day will be administered over 30-60 minutes intravenous infusion on Days -6 through -2 for a total dose of 150 mg/m\^2 Melphalan: Melphalan 70 mg/m\^2 over 45 minutes will be administered Day -6. Melphalan dose will be calculated based on Actual Body Weight. Total Body Irradiation: Total Body Irradiation (TBI) will be delivered at a dose of 200 centigray units (cGy)

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

Analysis denominator · Participants

Group	Source count
Conditioning Regimen + Transplant	34

Reported measurements

Source class 1

Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Conditioning Regimen + Transplant	70.6	Not reported	59.2	100	Not reported

Source statistical analyses

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

ci Lower Limit
59.2
ci Num Sides
ONE_SIDED
ci Pct Value
90
group Ids
OG000
non Inferiority Type
SUPERIORITY
p Value
0.002
p Value Comment
One sided log rank test
param Type
PFS at 18 Months
param Value
70.8
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
59.2
ci Num Sides
ONE_SIDED
ci Pct Value
90
group Ids
OG000
non Inferiority Type
SUPERIORITY
p Value
0.002
p Value Comment
One sided log rank test
param Type
PFS at 18 Months
param Value
70.8
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
59.2
upper Limit
100
value
70.6

denoms

counts
group Id
OG000
value
34
units
Participants

description

Disease Free Survival (DFS) is defined as the time from the date of Peripheral Blood Stem Cell Transplant (PBSCT) to first documentation of relapse or death due to any cause, whichever comes first.

dispersion Type

90% Confidence Interval

groups

description
All participants will receive a conditioning regimen of Fludarabine, Melphalan and Total Body Irradiation prior to transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT) Fludarabine: Fludarabine 30mg/m\^2/day will be administered over 30-60 minutes intravenous infusion on Days -6 through -2 for a total dose of 150 mg/m\^2 Melphalan: Melphalan 70 mg/m\^2 over 45 minutes will be administered Day -6. Melphalan dose will be calculated based on Actual Body Weight. Total Body Irradiation: Total Body Irradiation (TBI) will be delivered at a dose of 200 centigray units (cGy)
id
OG000
title
Conditioning Regimen + Transplant

param Type

NUMBER

population Description

Evaluable Participants

reporting Status

POSTED

time Frame

Up to 18 months post-transplant

title

Disease Free Survival

type

PRIMARY

unit Of Measure

percentage of participants

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

Preserved source evidence · Not medical advice