NCT02988466 · OUTCOME

Relapse Incidence

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: 1 and 2 year

What was measured

Percentage of participants experiencing a relapse incidence at 1 and 2 years.

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

Relapse Incidence 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	29	Not reported	5	52	Not reported
CLOSED Arm B: Haplo-HCT ≥55 Years Old	29	Not reported	11	46	Not reported
Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo	75	Not reported	43	100	Not reported
Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3	26	Not reported	11	40	Not reported

Relapse Incidence 2 year

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm A: Haplo-HCT <55 Years Old	29	Not reported	5	52	Not reported
CLOSED Arm B: Haplo-HCT ≥55 Years Old	30	Not reported	11	49	Not reported
Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo	75	Not reported	39	100	Not reported
Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3	28	Not reported	12	43	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
5
upper Limit
52
value
29
group Id
OG001
lower Limit
11
upper Limit
46
value
29
group Id
OG002
lower Limit
43
upper Limit
100
value
75
group Id
OG003
lower Limit
11
upper Limit
40
value
26
title
Relapse Incidence 1 year
categories
measurements
group Id
OG000
lower Limit
5
upper Limit
52
value
29
group Id
OG001
lower Limit
11
upper Limit
49
value
30
group Id
OG002
lower Limit
39
upper Limit
100
value
75
group Id
OG003
lower Limit
12
upper Limit
43
value
28
title
Relapse Incidence 2 year

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 a relapse incidence at 1 and 2 years.

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

1 and 2 year

title

Relapse Incidence

type

SECONDARY

unit Of Measure

Percentage of participants

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

Preserved source evidence · Not medical advice