NCT02988466 · OUTCOME

Treatment Related Mortality (TRM)

Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haplo-HCT · Source last updated 2025-05-28

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: 6 month, 1 and 2 year

What was measured

Percentage of participants experiencing treatment related mortality (TRM).

Groups in this outcome

Arm A: Haplo-HCT <55 Years Old

Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients \<55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 Haplo HCT \<55 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion Day 0 GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF)

CLOSED Arm B: Haplo-HCT ≥55 Years Old

Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. Haplo HCT ≥55 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel): Dose reduction by 30% * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF)

Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo

Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and \< 65 years old. GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) Haplo HCT ≥55 and \< 65 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * non-T-cell depleted donor bone marrow stem cells

Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3

Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) Haplo HCT ≥65 and ≤75 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Total body irradiation (TBI)

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
Arm A: Haplo-HCT <55 Years Old	14
CLOSED Arm B: Haplo-HCT ≥55 Years Old	21
Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo	8
Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3	35

Reported measurements

TRM 6 months

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm A: Haplo-HCT <55 Years Old	21	Not reported	1	42	Not reported
CLOSED Arm B: Haplo-HCT ≥55 Years Old	57	Not reported	39	75	Not reported
Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo	13	Not reported	0	34	Not reported
Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3	26	Not reported	13	38	Not reported

TRM 1 year

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm A: Haplo-HCT <55 Years Old	21	Not reported	1	42	Not reported
CLOSED Arm B: Haplo-HCT ≥55 Years Old	57	Not reported	35	79	Not reported
Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo	13	Not reported	0	34	Not reported
Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3	26	Not reported	11	40	Not reported

TRM 2 years

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm A: Haplo-HCT <55 Years Old	21	Not reported	1	42	Not reported
CLOSED Arm B: Haplo-HCT ≥55 Years Old	58	Not reported	36	81	Not reported
Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo	13	Not reported	0	34	Not reported
Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3	27	Not reported	12	42	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
1
upper Limit
42
value
21
group Id
OG001
lower Limit
39
upper Limit
75
value
57
group Id
OG002
lower Limit
0
upper Limit
34
value
13
group Id
OG003
lower Limit
13
upper Limit
38
value
26
title
TRM 6 months
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
42
value
21
group Id
OG001
lower Limit
35
upper Limit
79
value
57
group Id
OG002
lower Limit
0
upper Limit
34
value
13
group Id
OG003
lower Limit
11
upper Limit
40
value
26
title
TRM 1 year
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
42
value
21
group Id
OG001
lower Limit
36
upper Limit
81
value
58
group Id
OG002
lower Limit
0
upper Limit
34
value
13
group Id
OG003
lower Limit
12
upper Limit
42
value
27
title
TRM 2 years

denoms

counts
group Id
OG000
value
14
group Id
OG001
value
21
group Id
OG002
value
8
group Id
OG003
value
35
units
Participants

description

Percentage of participants experiencing treatment related mortality (TRM).

dispersion Type

95% Confidence Interval

groups

description
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients \<55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 Haplo HCT \<55 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion Day 0 GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF)
id
OG000
title
Arm A: Haplo-HCT <55 Years Old
description
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. Haplo HCT ≥55 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel): Dose reduction by 30% * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF)
id
OG001
title
CLOSED Arm B: Haplo-HCT ≥55 Years Old
description
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and \< 65 years old. GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) Haplo HCT ≥55 and \< 65 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * non-T-cell depleted donor bone marrow stem cells
id
OG002
title
Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo
description
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) Haplo HCT ≥65 and ≤75 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Total body irradiation (TBI)
id
OG003
title
Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3

param Type

NUMBER

reporting Status

POSTED

time Frame

6 month, 1 and 2 year

title

Treatment Related Mortality (TRM)

type

SECONDARY

unit Of Measure

Percentage of participants

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

Preserved source evidence · Not medical advice