NCT00589316 · OUTCOME

Severity of Acute GVHD in Patients Who Completed the Study Treatment

Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation and Donor Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or High-Risk Myelodysplastic Syndrome · Source last updated 2023-02-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: 100 days after transplant

What was measured

The severity of acute GVHD is measured based on Graft vs Host Disease: Grade I +1 to +2 skin rash No gut or liver involvement Grade II +3 skin rash or * 1 gastrointestinal involvement and/or +1 liver involvement Grade III +2 to +4 gastrointestinal involvement and/or * 2 to +4 liver involvement with or without a rash Grade IV Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death

Groups in this outcome

Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody

RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI

Dose Level 2: 14 Gy Iodine-131 + BC8 Monoclonal Antibody

Dose Level 3: 16 Gy Iodine-131 + BC8 Monoclonal Antibody

Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody

Dose Level 5: 20 Gy Iodine-131 + BC8 Monoclonal Antibody

Dose Level 6: 22 Gy Iodine-131 + BC8 Monoclonal Antibody

Dose Level 7: 24 Gy Iodine-131 + BC8 Monoclonal Antibody

Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody	1
Dose Level 2: 14 Gy Iodine-131 + BC8 Monoclonal Antibody	1
Dose Level 3: 16 Gy Iodine-131 + BC8 Monoclonal Antibody	5
Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody	1
Dose Level 5: 20 Gy Iodine-131 + BC8 Monoclonal Antibody	1
Dose Level 6: 22 Gy Iodine-131 + BC8 Monoclonal Antibody	2
Dose Level 7: 24 Gy Iodine-131 + BC8 Monoclonal Antibody	7
Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody	7

Reported measurements

Source class 1

Number of participants with Grade 0 - 1 GVHD

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody	0	Not reported	Not reported	Not reported	Not reported
Dose Level 2: 14 Gy Iodine-131 + BC8 Monoclonal Antibody	0	Not reported	Not reported	Not reported	Not reported
Dose Level 3: 16 Gy Iodine-131 + BC8 Monoclonal Antibody	1	Not reported	Not reported	Not reported	Not reported
Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody	0	Not reported	Not reported	Not reported	Not reported
Dose Level 5: 20 Gy Iodine-131 + BC8 Monoclonal Antibody	0	Not reported	Not reported	Not reported	Not reported
Dose Level 6: 22 Gy Iodine-131 + BC8 Monoclonal Antibody	1	Not reported	Not reported	Not reported	Not reported
Dose Level 7: 24 Gy Iodine-131 + BC8 Monoclonal Antibody	1	Not reported	Not reported	Not reported	Not reported
Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody	1	Not reported	Not reported	Not reported	Not reported

Number of participants with Grade 2 GVHD

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody	1	Not reported	Not reported	Not reported	Not reported
Dose Level 2: 14 Gy Iodine-131 + BC8 Monoclonal Antibody	1	Not reported	Not reported	Not reported	Not reported
Dose Level 3: 16 Gy Iodine-131 + BC8 Monoclonal Antibody	1	Not reported	Not reported	Not reported	Not reported
Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody	1	Not reported	Not reported	Not reported	Not reported
Dose Level 5: 20 Gy Iodine-131 + BC8 Monoclonal Antibody	1	Not reported	Not reported	Not reported	Not reported
Dose Level 6: 22 Gy Iodine-131 + BC8 Monoclonal Antibody	1	Not reported	Not reported	Not reported	Not reported
Dose Level 7: 24 Gy Iodine-131 + BC8 Monoclonal Antibody	3	Not reported	Not reported	Not reported	Not reported
Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody	4	Not reported	Not reported	Not reported	Not reported

Number of participants with Grade 3 GVHD

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody	0	Not reported	Not reported	Not reported	Not reported
Dose Level 2: 14 Gy Iodine-131 + BC8 Monoclonal Antibody	0	Not reported	Not reported	Not reported	Not reported
Dose Level 3: 16 Gy Iodine-131 + BC8 Monoclonal Antibody	2	Not reported	Not reported	Not reported	Not reported
Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody	0	Not reported	Not reported	Not reported	Not reported
Dose Level 5: 20 Gy Iodine-131 + BC8 Monoclonal Antibody	0	Not reported	Not reported	Not reported	Not reported
Dose Level 6: 22 Gy Iodine-131 + BC8 Monoclonal Antibody	0	Not reported	Not reported	Not reported	Not reported
Dose Level 7: 24 Gy Iodine-131 + BC8 Monoclonal Antibody	0	Not reported	Not reported	Not reported	Not reported
Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody	1	Not reported	Not reported	Not reported	Not reported

Number of participants with unknown GVHD

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody	0	Not reported	Not reported	Not reported	Not reported
Dose Level 2: 14 Gy Iodine-131 + BC8 Monoclonal Antibody	0	Not reported	Not reported	Not reported	Not reported
Dose Level 3: 16 Gy Iodine-131 + BC8 Monoclonal Antibody	1	Not reported	Not reported	Not reported	Not reported
Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody	0	Not reported	Not reported	Not reported	Not reported
Dose Level 5: 20 Gy Iodine-131 + BC8 Monoclonal Antibody	0	Not reported	Not reported	Not reported	Not reported
Dose Level 6: 22 Gy Iodine-131 + BC8 Monoclonal Antibody	0	Not reported	Not reported	Not reported	Not reported
Dose Level 7: 24 Gy Iodine-131 + BC8 Monoclonal Antibody	3	Not reported	Not reported	Not reported	Not reported
Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
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title
Number of participants with Grade 0 - 1 GVHD
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Number of participants with Grade 2 GVHD
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Number of participants with Grade 3 GVHD
measurements
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Number of participants with unknown GVHD

denoms

counts
group Id
OG000
value
1
group Id
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units
Participants

description

groups

description
RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
id
OG000
title
Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody
description
RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
id
OG001
title
Dose Level 2: 14 Gy Iodine-131 + BC8 Monoclonal Antibody
description
RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
id
OG002
title
Dose Level 3: 16 Gy Iodine-131 + BC8 Monoclonal Antibody
description
RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
id
OG003
title
Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody
description
RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
id
OG004
title
Dose Level 5: 20 Gy Iodine-131 + BC8 Monoclonal Antibody
description
RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
id
OG005
title
Dose Level 6: 22 Gy Iodine-131 + BC8 Monoclonal Antibody
description
RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
id
OG006
title
Dose Level 7: 24 Gy Iodine-131 + BC8 Monoclonal Antibody
description
RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
id
OG007
title
Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody

param Type

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

100 days after transplant

title

Severity of Acute GVHD in Patients Who Completed the Study Treatment

type

SECONDARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice