NCT00119366 · ADVERSE EVENTS

Adverse events

Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Total Body Irradiation, and Donor Stem Cell Transplant Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome · Source last updated 2022-12-12

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: Serious adverse events and Other (not including serious adverse events) were monitored and recorded from the time of first exposure to the investigational product (i.e. Iodine 131 + BC8 mAB) through day +100 post-transplant or through patient discharge from the Seattle Cancer Care Alliance (SCCA) system to the patient's primary physician. All-Cause Mortality was monitored/assessed for up to 2 years or through participant survival after completing the study regimen and transplant.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Dose Level 1: 12 Gy Iodine-131+ BC8 Monoclonal Antibody RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies	1 / 1	0 / 1	1 / 1
Dose Level 7: 22 Gy Iodine-131+ BC8 Monoclonal Antibody RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies	2 / 2	0 / 2	0 / 2
Dose Level 8: 24 Gy Iodine-131+ BC8 Monoclonal Antibody RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies	3 / 3	1 / 3	2 / 3
Dose Level 9: 26 Gy Iodine-131+ BC8 Monoclonal Antibody RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies	2 / 2	2 / 2	2 / 2
Dose Level 10: 28 Gy Iodine-131+ BC8 Monoclonal Antibody RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies	8 / 8	5 / 8	2 / 8

Group identifiers: EG000: Dose Level 1: 12 Gy Iodine-131+ BC8 Monoclonal Antibody · EG001: Dose Level 7: 22 Gy Iodine-131+ BC8 Monoclonal Antibody · EG002: Dose Level 8: 24 Gy Iodine-131+ BC8 Monoclonal Antibody · EG003: Dose Level 9: 26 Gy Iodine-131+ BC8 Monoclonal Antibody · EG004: Dose Level 10: 28 Gy Iodine-131+ BC8 Monoclonal Antibody

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
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
8
num Events
1
term
Engraftment Syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Atrial Fibrillation
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
1
num At Risk
2
num Events
1
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
term
Supraventricular and nodal arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Low blood pressure
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
1
num At Risk
2
num Events
2
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
2
num Events
1
group Id
EG004
num Affected
1
num At Risk
8
num Events
1
term
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
2
num Events
1
group Id
EG004
num Affected
1
num At Risk
8
num Events
1
term
Rigors/Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
8
num Events
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Difficulty swallowing
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
term
Mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
2
num At Risk
3
num Events
2
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
term
Stomatitis

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
notes
Allergic reaction/hypersensitivity (including drug fever)
organ System
Immune system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
2
num At Risk
8
num Events
2
term
Allergic reaction/hypersensitivity (including drug fever)
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Anorexia
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
2
num At Risk
8
num Events
4
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Hearing loss
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
term
Hearing loss
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Leukocytes (total WBC)
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
8
num Events
1
term
Leukocytes (total WBC)
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Neutrophils/granulocytes (ANC/AGC)
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
8
num Events
1
term
Neutrophils/granulocytes (ANC/AGC)
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Platelets
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
2
num At Risk
8
num Events
2
term
Platelets
assessment Type
SYSTEMATIC_ASSESSMENT
notes
WBC
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
8
num Events
1
term
WBC
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Hypertension
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
2
num Events
1
group Id
EG004
num Affected
1
num At Risk
8
num Events
1
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Pericardial effusion
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
8
num Events
1
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Fatigue
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
8
num Events
4
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Fever
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
8
num Events
2
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Rigors/chills
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
2
num At Risk
8
num Events
2
term
Rigors/chills

Complete source fields

event Groups

deaths Num Affected
1
deaths Num At Risk
1
description
RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies
id
EG000
other Num Affected
0
other Num At Risk
1
serious Num Affected
1
serious Num At Risk
1
title
Dose Level 1: 12 Gy Iodine-131+ BC8 Monoclonal Antibody
deaths Num Affected
0
deaths Num At Risk
2
description
RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies
id
EG001
other Num Affected
0
other Num At Risk
2
serious Num Affected
2
serious Num At Risk
2
title
Dose Level 7: 22 Gy Iodine-131+ BC8 Monoclonal Antibody
deaths Num Affected
2
deaths Num At Risk
3
description
RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies
id
EG002
other Num Affected
1
other Num At Risk
3
serious Num Affected
3
serious Num At Risk
3
title
Dose Level 8: 24 Gy Iodine-131+ BC8 Monoclonal Antibody
deaths Num Affected
2
deaths Num At Risk
2
description
RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies
id
EG003
other Num Affected
2
other Num At Risk
2
serious Num Affected
2
serious Num At Risk
2
title
Dose Level 9: 26 Gy Iodine-131+ BC8 Monoclonal Antibody
deaths Num Affected
2
deaths Num At Risk
8
description
RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96. iodine I 131 monoclonal antibody BC8: Given IV fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo PBSC transplantation peripheral blood stem cell transplantation: Undergo PBSC transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given PO laboratory biomarker analysis: Correlative studies
id
EG004
other Num Affected
5
other Num At Risk
8
serious Num Affected
8
serious Num At Risk
8
title
Dose Level 10: 28 Gy Iodine-131+ BC8 Monoclonal Antibody

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Allergic reaction/hypersensitivity (including drug fever)
organ System
Immune system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
2
num At Risk
8
num Events
2
term
Allergic reaction/hypersensitivity (including drug fever)
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Anorexia
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
2
num At Risk
8
num Events
4
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Hearing loss
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
term
Hearing loss
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Leukocytes (total WBC)
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
8
num Events
1
term
Leukocytes (total WBC)
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Neutrophils/granulocytes (ANC/AGC)
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
8
num Events
1
term
Neutrophils/granulocytes (ANC/AGC)
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Platelets
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
2
num At Risk
8
num Events
2
term
Platelets
assessment Type
SYSTEMATIC_ASSESSMENT
notes
WBC
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
8
num Events
1
term
WBC
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Hypertension
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
2
num Events
1
group Id
EG004
num Affected
1
num At Risk
8
num Events
1
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Pericardial effusion
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
8
num Events
1
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Fatigue
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
8
num Events
4
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Fever
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
8
num Events
2
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Rigors/chills
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
2
num At Risk
8
num Events
2
term
Rigors/chills

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
8
num Events
1
term
Engraftment Syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Atrial Fibrillation
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
1
num At Risk
2
num Events
1
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
term
Supraventricular and nodal arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Low blood pressure
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
1
num At Risk
2
num Events
2
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
2
num Events
1
group Id
EG004
num Affected
1
num At Risk
8
num Events
1
term
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
2
num Events
1
group Id
EG004
num Affected
1
num At Risk
8
num Events
1
term
Rigors/Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
8
num Events
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Difficulty swallowing
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
term
Mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
2
num At Risk
3
num Events
2
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
term
Stomatitis

time Frame

Serious adverse events and Other (not including serious adverse events) were monitored and recorded from the time of first exposure to the investigational product (i.e. Iodine 131 + BC8 mAB) through day +100 post-transplant or through patient discharge from the Seattle Cancer Care Alliance (SCCA) system to the patient's primary physician. All-Cause Mortality was monitored/assessed for up to 2 years or through participant survival after completing the study regimen and transplant.

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