NCT02988466 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: 2 years
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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)	6 / 14	10 / 14	6 / 14
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)	9 / 21	11 / 21	13 / 21
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	4 / 8	6 / 8	5 / 8
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)	11 / 35	15 / 35	18 / 35

Group identifiers: EG000: Arm A: Haplo-HCT <55 Years Old · EG001: CLOSED Arm B: Haplo-HCT ≥55 Years Old · EG002: Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo · EG003: Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
6
num At Risk
14
num Events
56
group Id
EG001
num Affected
9
num At Risk
21
num Events
133
group Id
EG002
num Affected
4
num At Risk
8
num Events
36
group Id
EG003
num Affected
11
num At Risk
35
num Events
109
term
Serious bacterial Infection

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
Fungal Infection
stats
group Id
EG000
num Affected
2
num At Risk
14
num Events
17
group Id
EG001
num Affected
2
num At Risk
21
num Events
51
group Id
EG002
num Affected
3
num At Risk
8
num Events
22
group Id
EG003
num Affected
4
num At Risk
35
num Events
27
term
Fungal Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
Viral Infection
stats
group Id
EG000
num Affected
9
num At Risk
14
num Events
95
group Id
EG001
num Affected
10
num At Risk
21
num Events
152
group Id
EG002
num Affected
6
num At Risk
8
num Events
43
group Id
EG003
num Affected
12
num At Risk
35
num Events
67
term
Viral Infection

Complete source fields

event Groups

deaths Num Affected
6
deaths Num At Risk
14
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
EG000
other Num Affected
10
other Num At Risk
14
serious Num Affected
6
serious Num At Risk
14
title
Arm A: Haplo-HCT <55 Years Old
deaths Num Affected
13
deaths Num At Risk
21
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
EG001
other Num Affected
11
other Num At Risk
21
serious Num Affected
9
serious Num At Risk
21
title
CLOSED Arm B: Haplo-HCT ≥55 Years Old
deaths Num Affected
5
deaths Num At Risk
8
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
EG002
other Num Affected
6
other Num At Risk
8
serious Num Affected
4
serious Num At Risk
8
title
Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo
deaths Num Affected
18
deaths Num At Risk
35
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
EG003
other Num Affected
15
other Num At Risk
35
serious Num Affected
11
serious Num At Risk
35
title
Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
Fungal Infection
stats
group Id
EG000
num Affected
2
num At Risk
14
num Events
17
group Id
EG001
num Affected
2
num At Risk
21
num Events
51
group Id
EG002
num Affected
3
num At Risk
8
num Events
22
group Id
EG003
num Affected
4
num At Risk
35
num Events
27
term
Fungal Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
Viral Infection
stats
group Id
EG000
num Affected
9
num At Risk
14
num Events
95
group Id
EG001
num Affected
10
num At Risk
21
num Events
152
group Id
EG002
num Affected
6
num At Risk
8
num Events
43
group Id
EG003
num Affected
12
num At Risk
35
num Events
67
term
Viral Infection

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
6
num At Risk
14
num Events
56
group Id
EG001
num Affected
9
num At Risk
21
num Events
133
group Id
EG002
num Affected
4
num At Risk
8
num Events
36
group Id
EG003
num Affected
11
num At Risk
35
num Events
109
term
Serious bacterial Infection

time Frame

2 years

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Preserved source evidence · Not medical advice