NCT02797470 · ADVERSE EVENTS

Adverse events

Gene Therapy in Treating Patients With Human Immunodeficiency Virus-Related Lymphoma Receiving Stem Cell Transplant · Source last updated 2026-05-18

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: 24 months after transplant
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:0 Ratio Patients receive BEAM regimen administered as standard of care comprising carmustine on day -6, cytarabine BID on days -5 to -2, etoposide BID on days -5 to -2, and melphalan on day -1. Patients undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells over 1 hour. Autologous Hematopoietic Stem Cell Transplantation: Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells Carmustine: 300 mg/m2 on Day -6, as part of BEAM and R-BEAM regimens. Cytarabine: 100 mg/m2 BID on Days -5 through -2, as part of BEAM and R-BEAM regimens. Etoposide: VP-16: 100 mg/m2 BID on Days -5 through -2, as part of BEAM and R-BEAM regimens. Laboratory Biomarker Analysis: Correlative studies Lentivirus Vector CCR5 shRNA/TRIM5alpha/TAR Decoy-transduced Autologous CD34-positive Hematopoietic Progenitor Cells: Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells Melphalan: 140 mg/m2 on Day -1, as part of BEAM and R-BEAM regimens. Peripheral Blood Stem Cell Transplantation: Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells	1 / 5	2 / 5	2 / 5
Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:1 Ratio Patients receive BEAM regimen administered as standard of care comprising carmustine on day -6, cytarabine BID on days -5 to -2, etoposide BID on days -5 to -2, and melphalan on day -1. Patients undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells over 1 hour. Autologous Hematopoietic Stem Cell Transplantation: Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells	1 / 4	4 / 4	2 / 4
Treatment (Anti-HIV Gene Transduced CD34+ Cells): 5:1 Ratio Patients receive BEAM regimen administered as standard of care comprising carmustine on day -6, cytarabine BID on days -5 to -2, etoposide BID on days -5 to -2, and melphalan on day -1. Patients undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells over 1 hour. Autologous Hematopoietic Stem Cell Transplantation: Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells	0 / 2	0 / 2	1 / 2

Group identifiers: EG000: Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:0 Ratio · EG001: Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:1 Ratio · EG002: Treatment (Anti-HIV Gene Transduced CD34+ Cells): 5:1 Ratio

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
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
PLATELET COUNT DECREASED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
BLOOD BILIRUBIN INCREASED

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
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
BLOOD BILIRUBIN INCREASED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
2
num At Risk
4
num Events
2
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
HYPOALBUMINEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
HYPOPHOSPHATEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
LYMPHOCYTE COUNT DECREASED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
2
num At Risk
4
num Events
2
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
NEUTROPHIL COUNT DECREASED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
2
num At Risk
4
num Events
2
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
PLATELET COUNT DECREASED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
2
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
WHITE BLOOD CELL DECREASED

Complete source fields

event Groups

deaths Num Affected
2
deaths Num At Risk
5
description
Patients receive BEAM regimen administered as standard of care comprising carmustine on day -6, cytarabine BID on days -5 to -2, etoposide BID on days -5 to -2, and melphalan on day -1. Patients undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells over 1 hour. Autologous Hematopoietic Stem Cell Transplantation: Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells Carmustine: 300 mg/m2 on Day -6, as part of BEAM and R-BEAM regimens. Cytarabine: 100 mg/m2 BID on Days -5 through -2, as part of BEAM and R-BEAM regimens. Etoposide: VP-16: 100 mg/m2 BID on Days -5 through -2, as part of BEAM and R-BEAM regimens. Laboratory Biomarker Analysis: Correlative studies Lentivirus Vector CCR5 shRNA/TRIM5alpha/TAR Decoy-transduced Autologous CD34-positive Hematopoietic Progenitor Cells: Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells Melphalan: 140 mg/m2 on Day -1, as part of BEAM and R-BEAM regimens. Peripheral Blood Stem Cell Transplantation: Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells
id
EG000
other Num Affected
2
other Num At Risk
5
serious Num Affected
1
serious Num At Risk
5
title
Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:0 Ratio
deaths Num Affected
2
deaths Num At Risk
4
description
Patients receive BEAM regimen administered as standard of care comprising carmustine on day -6, cytarabine BID on days -5 to -2, etoposide BID on days -5 to -2, and melphalan on day -1. Patients undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells over 1 hour. Autologous Hematopoietic Stem Cell Transplantation: Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells
id
EG001
other Num Affected
4
other Num At Risk
4
serious Num Affected
1
serious Num At Risk
4
title
Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:1 Ratio
deaths Num Affected
1
deaths Num At Risk
2
description
Patients receive BEAM regimen administered as standard of care comprising carmustine on day -6, cytarabine BID on days -5 to -2, etoposide BID on days -5 to -2, and melphalan on day -1. Patients undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells over 1 hour. Autologous Hematopoietic Stem Cell Transplantation: Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells
id
EG002
other Num Affected
0
other Num At Risk
2
serious Num Affected
0
serious Num At Risk
2
title
Treatment (Anti-HIV Gene Transduced CD34+ Cells): 5:1 Ratio

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
BLOOD BILIRUBIN INCREASED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
2
num At Risk
4
num Events
2
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
HYPOALBUMINEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
HYPOPHOSPHATEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
LYMPHOCYTE COUNT DECREASED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
2
num At Risk
4
num Events
2
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
NEUTROPHIL COUNT DECREASED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
2
num At Risk
4
num Events
2
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
PLATELET COUNT DECREASED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
2
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
WHITE BLOOD CELL DECREASED

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
PLATELET COUNT DECREASED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
BLOOD BILIRUBIN INCREASED

time Frame

24 months after transplant

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Preserved source evidence · Not medical advice