Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation and Donor Bone Marrow Transplant in Treating Patients With Advanced Acute Myel

Draft scope assessment: unclear. Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

The criteria of Grade III/IV regimen-related toxicity (Bearman) or dose-limiting toxicity (DLT) are as follows: Grade 1 Development of transient chemical abnormalities which are not of major clinical consequence and which reverse without requiring major medical interventions. In general, the intent of this toxicity scale is to observe transient target organ toxicity which is reversible. Grade 2 Development of chemical or laboratory abnormalities that are persistent and which may represent target organ damage that may not be readily reversed. It is anticipated that at this dose of the drug, the toxicity obtained would be manageable by clinical methods but may interfere with other therapies. Grade 3 Development of major clinical, chemical or laboratory abnormalities which represent maximum toxicities without being fatal. This grade of toxicity is designed to be the dose-limiting toxicity. Grade 4 Fatal

Number of participants that experienced a dose-limiting toxicity (DLT) within 30 days following transplant.

→

secondary · POSTED

Number of Participants that received and completed study treatment who died within 100 days after transplant

Source null

→

secondary · POSTED

The number of participants that are in complete remission or relapsed within 90 days after transplant Complete Remission is defined as the complete resolution of all signs of leukemia for at least 90 days with all of the following: 1. Normal bone marrow with blasts \<5% with normal cellularity, normal megakarypoiesis, more than 15% erythropoiesis, and more than 25% granulocytopoiesis. 2. Normalization of blood counts (no blasts, platelets \> 100000/mm3, granulocytes \>1500/mm3) 3. No extramedullary disease Relapse is measured as follows: 1. After CR: \>5% blasts in the bone marrow and/or peripheral blood. Confirmation of relapse by bone marrow analysis with more than 10% blasts. 2. After PR: increase of blast cells in the marrow to \>50% of those during PR. 3. Extramedullary disease confirmed cytologically or histologically.

Source null

→

secondary · POSTED

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

Source null

→

secondary · POSTED

Post-transplant bone marrow and peripheral blood samples were collected on day 84 after transplant for DNA Chimerism Analysis

Source null

→

secondary · POSTED

Survival and complete resolution of all signs of leukemia 2 years after transplant with all of the following: 1, Normal bone marrow with blasts \<5% with normal cellularity, normal megakaryopoiesis, more than 15% erythropoiesis, and more than 25% granulocytopoiesis. 2\. Normalization of blood counts (no basts, platelets \>100,000/mm3, granulocytes \>1,500/mm3) 3. No extramedullary disease.

Participants who are alive and disease-free 2 years after transplant

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-acute-lymphoblastic-leukemia-imkeldi-c3890f27
nct id: NCT00589316
trial label: Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation and Donor Bone Marrow Transplant in Treating Patients With Advanced Acute Myel
applicability: unclear
applicability note: Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 8
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-imkeldi-c3890f27
nct id
NCT00589316
outcome key
om-0000
source section id
NCT00589316-om-0000
source outcome index
0
endpoint
Number of Participants With Dose-limiting Toxicities (DLT) 30 Days After Transplant
endpoint definition
The criteria of Grade III/IV regimen-related toxicity (Bearman) or dose-limiting toxicity (DLT) are as follows: Grade 1 Development of transient chemical abnormalities which are not of major clinical consequence and which reverse without requiring major medical interventions. In general, the intent of this toxicity scale is to observe transient target organ toxicity which is reversible. Grade 2 Development of chemical or laboratory abnormalities that are persistent and which may represent target organ damage that may not be readily reversed. It is anticipated that at this dose of the drug, the toxicity obtained would be manageable by clinical methods but may interfere with other therapies. Grade 3 Development of major clinical, chemical or laboratory abnormalities which represent maximum toxicities without being fatal. This grade of toxicity is designed to be the dose-limiting toxicity. Grade 4 Fatal
time origin
Up to 30 days post-transplant
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Number of participants that experienced a dose-limiting toxicity (DLT) within 30 days following transplant.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-imkeldi-c3890f27
nct id
NCT00589316
outcome key
om-0001
source section id
NCT00589316-om-0001
source outcome index
1
endpoint
Number of Participants With Transplant-Related Mortality Within 100 Days After Transplant
endpoint definition
Number of Participants that received and completed study treatment who died within 100 days after transplant
time origin
Up to 100 days post-transplant
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-imkeldi-c3890f27
nct id
NCT00589316
outcome key
om-0002
source section id
NCT00589316-om-0002
source outcome index
2
endpoint
Participant Disease Response Within 90 Days After Transplant
endpoint definition
The number of participants that are in complete remission or relapsed within 90 days after transplant Complete Remission is defined as the complete resolution of all signs of leukemia for at least 90 days with all of the following: 1. Normal bone marrow with blasts \<5% with normal cellularity, normal megakarypoiesis, more than 15% erythropoiesis, and more than 25% granulocytopoiesis. 2. Normalization of blood counts (no blasts, platelets \> 100000/mm3, granulocytes \>1500/mm3) 3. No extramedullary disease Relapse is measured as follows: 1. After CR: \>5% blasts in the bone marrow and/or peripheral blood. Confirmation of relapse by bone marrow analysis with more than 10% blasts. 2. After PR: increase of blast cells in the marrow to \>50% of those during PR. 3. Extramedullary disease confirmed cytologically or histologically.
time origin
Up to 90 days after transplant
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-imkeldi-c3890f27
nct id
NCT00589316
outcome key
om-0003
source section id
NCT00589316-om-0003
source outcome index
3
endpoint
Severity of Acute GVHD in Patients Who Completed the Study Treatment
endpoint definition
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
time origin
100 days after transplant
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-imkeldi-c3890f27
nct id
NCT00589316
outcome key
om-0004
source section id
NCT00589316-om-0004
source outcome index
4
endpoint
Number of Participants With 100% Donor Chimerism at Day 84
endpoint definition
Post-transplant bone marrow and peripheral blood samples were collected on day 84 after transplant for DNA Chimerism Analysis
time origin
Day 84 after transplant
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-imkeldi-c3890f27
nct id
NCT00589316
outcome key
om-0005
source section id
NCT00589316-om-0005
source outcome index
5
endpoint
Two-Year Disease-free Survival of Study Participants Who Completed the Study Regimen
endpoint definition
Survival and complete resolution of all signs of leukemia 2 years after transplant with all of the following: 1, Normal bone marrow with blasts \<5% with normal cellularity, normal megakaryopoiesis, more than 15% erythropoiesis, and more than 25% granulocytopoiesis. 2\. Normalization of blood counts (no basts, platelets \>100,000/mm3, granulocytes \>1,500/mm3) 3. No extramedullary disease.
time origin
2 years post-transplant
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants who are alive and disease-free 2 years after transplant
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-imkeldi-c3890f27
nct id
NCT00589316
outcome key
om-0000
arm key
OG000
arm label
Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody
regimen
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
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00589316-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-imkeldi-c3890f27
nct id
NCT00589316
outcome key
om-0000
arm key
OG001
arm label
Dose Level 2: 14 Gy Iodine-131 + BC8 Monoclonal Antibody
regimen
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
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00589316-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-imkeldi-c3890f27
nct id
NCT00589316
outcome key
om-0000
arm key
OG002
arm label
Dose Level 3: 16 Gy Iodine-131 + BC8 Monoclonal Antibody
regimen
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
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00589316-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-imkeldi-c3890f27
nct id
NCT00589316
outcome key
om-0000
arm key
OG003
arm label
Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody
regimen
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
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00589316-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-imkeldi-c3890f27
nct id
NCT00589316
outcome key
om-0000
arm key
OG004
arm label
Dose Level 5: 20 Gy Iodine-131 + BC8 Monoclonal Antibody
regimen
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
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00589316-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-imkeldi-c3890f27
nct id
NCT00589316
outcome key
om-0000
arm key
OG005
arm label
Dose Level 6: 22 Gy Iodine-131 + BC8 Monoclonal Antibody
regimen
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
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00589316-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-imkeldi-c3890f27
nct id
NCT00589316
outcome key
om-0000
arm key
OG006
arm label
Dose Level 7: 24 Gy Iodine-131 + BC8 Monoclonal Antibody
regimen
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
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00589316-om-0000#groups/OG006
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-imkeldi-c3890f27
nct id
NCT00589316
outcome key
om-0000
arm key
OG007
arm label
Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody
regimen
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
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00589316-om-0000#groups/OG007
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-imkeldi-c3890f27
nct id
NCT00589316
outcome key
om-0001
arm key
OG000
arm label
Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody
regimen
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
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00589316-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-imkeldi-c3890f27
nct id
NCT00589316
outcome key
om-0001
arm key
OG001
arm label
Dose Level 2: 14 Gy Iodine-131 + BC8 Monoclonal Antibody
regimen
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
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00589316-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-imkeldi-c3890f27
nct id
NCT00589316
outcome key
om-0001
arm key
OG002
arm label
Dose Level 3: 16 Gy Iodine-131 + BC8 Monoclonal Antibody
regimen
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
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00589316-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-imkeldi-c3890f27
nct id
NCT00589316
outcome key
om-0001
arm key
OG003
arm label
Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody
regimen
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
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00589316-om-0001#groups/OG003

harms

release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-imkeldi-c3890f27
nct id
NCT00589316
harm key
EG000
source section id
NCT00589316-ae
event group key
EG000
event group label
Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody
serious affected
1
serious at risk
1
other affected
1
other at risk
1
frequency threshold
0
collection period
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.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-imkeldi-c3890f27
nct id
NCT00589316
harm key
EG001
source section id
NCT00589316-ae
event group key
EG001
event group label
Dose Level 2: 14 Gy Iodine-131 + BC8 Monoclonal Antibody
serious affected
1
serious at risk
1
other affected
1
other at risk
1
frequency threshold
0
collection period
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.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-imkeldi-c3890f27
nct id
NCT00589316
harm key
EG002
source section id
NCT00589316-ae
event group key
EG002
event group label
Dose Level 3: 16 Gy Iodine-131 + BC8 Monoclonal Antibody
serious affected
4
serious at risk
5
other affected
5
other at risk
5
frequency threshold
0
collection period
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.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-imkeldi-c3890f27
nct id
NCT00589316
harm key
EG003
source section id
NCT00589316-ae
event group key
EG003
event group label
Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody
serious affected
1
serious at risk
1
other affected
1
other at risk
1
frequency threshold
0
collection period
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.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-imkeldi-c3890f27
nct id
NCT00589316
harm key
EG004
source section id
NCT00589316-ae
event group key
EG004
event group label
Dose Level 5: 20 Gy Iodine-131 + BC8 Monoclonal Antibody
serious affected
0
serious at risk
1
other affected
1
other at risk
1
frequency threshold
0
collection period
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.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-imkeldi-c3890f27
nct id
NCT00589316
harm key
EG005
source section id
NCT00589316-ae
event group key
EG005
event group label
Dose Level 6: 22 Gy Iodine-131 + BC8 Monoclonal Antibody
serious affected
2
serious at risk
2
other affected
2
other at risk
2
frequency threshold
0
collection period
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.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-imkeldi-c3890f27
nct id
NCT00589316
harm key
EG006
source section id
NCT00589316-ae
event group key
EG006
event group label
Dose Level 7: 24 Gy Iodine-131 + BC8 Monoclonal Antibody
serious affected
5
serious at risk
7
other affected
6
other at risk
7
frequency threshold
0
collection period
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.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-imkeldi-c3890f27
nct id
NCT00589316
harm key
EG007
source section id
NCT00589316-ae
event group key
EG007
event group label
Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody
serious affected
7
serious at risk
7
other affected
7
other at risk
7
frequency threshold
0
collection period
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.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice