NCT00040846 · ADVERSE EVENTS

Adverse events

Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies · Source last updated 2020-01-29

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: AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Other-event reporting threshold: 0%

No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Dose Level 1 (No Campath) CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO	24 / 60	33 / 60	Not reported / Not reported
Dose Level 2 (0.025 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	0 / 0	0 / 0	Not reported / Not reported
Dose Level 3 (0.050 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	0 / 0	0 / 0	Not reported / Not reported
Dose Level 4 (0.10 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	0 / 0	0 / 0	Not reported / Not reported
Dose Level 5 (0.20 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	0 / 0	0 / 0	Not reported / Not reported
Dose Level 6 (0.40 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	0 / 0	0 / 0	Not reported / Not reported

Group identifiers: EG000: Dose Level 1 (No Campath) · EG001: Dose Level 2 (0.025 mg/kg/Day Campath) · EG002: Dose Level 3 (0.050 mg/kg/Day Campath) · EG003: Dose Level 4 (0.10 mg/kg/Day Campath) · EG004: Dose Level 5 (0.20 mg/kg/Day Campath) · EG005: Dose Level 6 (0.40 mg/kg/Day Campath)

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
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Cardiac troponin I increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Gastric perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
4
num At Risk
60
num Events
4
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Multi-organ failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
8
num At Risk
60
num Events
8
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
GVHD
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
5
num At Risk
60
num Events
5
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Secondary Malignancy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Leukoencephalopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Hypoxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Pleural hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
60
num Events
3
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Respiratory failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Thromboembolic event

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
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
2
num At Risk
60
num Events
3
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Adult respiratory distress syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Anaphylaxis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Ataxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
2
num At Risk
60
num Events
3
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Blood and lymphatic system disorders - Other (Coagulopathy)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
13
num At Risk
60
num Events
13
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
2
num At Risk
60
num Events
2
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Capillary leak syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
5
num At Risk
60
num Events
5
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Creatinine increased

Complete source fields

description

No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.

event Groups

description
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO
id
EG000
other Num Affected
33
other Num At Risk
60
serious Num Affected
24
serious Num At Risk
60
title
Dose Level 1 (No Campath)
description
CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
id
EG001
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Dose Level 2 (0.025 mg/kg/Day Campath)
description
CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
id
EG002
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Dose Level 3 (0.050 mg/kg/Day Campath)
description
CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
id
EG003
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Dose Level 4 (0.10 mg/kg/Day Campath)
description
CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
id
EG004
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Dose Level 5 (0.20 mg/kg/Day Campath)
description
CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
id
EG005
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Dose Level 6 (0.40 mg/kg/Day Campath)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
2
num At Risk
60
num Events
3
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Adult respiratory distress syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Anaphylaxis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Ataxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
2
num At Risk
60
num Events
3
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Blood and lymphatic system disorders - Other (Coagulopathy)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
13
num At Risk
60
num Events
13
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
2
num At Risk
60
num Events
2
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Capillary leak syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
5
num At Risk
60
num Events
5
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Creatinine increased

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Cardiac troponin I increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Gastric perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
4
num At Risk
60
num Events
4
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Multi-organ failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
8
num At Risk
60
num Events
8
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
GVHD
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
5
num At Risk
60
num Events
5
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Secondary Malignancy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Leukoencephalopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Hypoxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Pleural hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
60
num Events
3
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Respiratory failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
1
num At Risk
60
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
0
num Events
0
group Id
EG004
num Affected
0
num At Risk
0
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Thromboembolic event

time Frame

AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200

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Preserved source evidence · Not medical advice