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← refractory Myelodysplastic Syndromes

NCT00119366 · STUDY IN CONTEXT

Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Total Body Irradiation, and Donor Stem Cell Transplant Followed by Cyclosporine and Mycophenolate Mofetil in Treating P

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.

Study participants that received and completed study treatment

→

secondary · POSTED

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

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

→

secondary · POSTED

The number of participants that are in complete remission (CR) or relapsed within 4 weeks after transplant. Complete Remission is defined as complete resolution of all signs of leukemia for at least four weeks with all of the following: * Normal bone marrow with blasts \<5% with normal cellularity, normal megakarypoiesis, more than 15% erythropoiesis and more than 25% granulocytopoiesis. * Normalization of blood counts (no blasts, platelets \>100,000/mm3, granulocytes \>1,500/mm3). * No extramedullary disease. Relapse is measured as follows: * After CR: \>5% blasts in the bone marrow and/or peripheral blood. * Confirmation of relapse by bone marrow analysis with more than 10% blasts. * Extramedullary disease confirmed cytologically or histologically.

Participants that received and completed study treatment

→

secondary · POSTED

The severity of acute GVHD is measured based on Graft-vs-Host Disease: Severity of GVHD 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

Study participants that completed study treatment

→

secondary · POSTED

Post-transplant bone marrow samples were collected on day 28 and day 84 after transplant for DNA Chimerism Analysis

Patients that completed the study regimen

→

secondary · POSTED

Survival and complete resolution of all signs of leukemia for 2 years after transplant 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 \>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-myelodysplastic-syndromes-refractory-a84ec8fd
nct id
NCT00119366
trial label
Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Total Body Irradiation, and Donor Stem Cell Transplant Followed by Cyclosporine and Mycophenolate Mofetil in Treating P
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
5
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00119366
    outcome key
    om-0000
    source section id
    NCT00119366-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With Dose-limiting Toxicities (DLT) 100 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.
    time origin
    Up to 100 days post-transplant
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Study participants that received and completed study treatment
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00119366
    outcome key
    om-0001
    source section id
    NCT00119366-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
    Participants that received and completed study treatment who died within 100 days after transplant
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00119366
    outcome key
    om-0002
    source section id
    NCT00119366-om-0002
    source outcome index
    2
    endpoint
    Participant Disease Response Within 4 Weeks After Transplant
    endpoint definition
    The number of participants that are in complete remission (CR) or relapsed within 4 weeks after transplant. Complete Remission is defined as complete resolution of all signs of leukemia for at least four weeks with all of the following: * Normal bone marrow with blasts \<5% with normal cellularity, normal megakarypoiesis, more than 15% erythropoiesis and more than 25% granulocytopoiesis. * Normalization of blood counts (no blasts, platelets \>100,000/mm3, granulocytes \>1,500/mm3). * No extramedullary disease. Relapse is measured as follows: * After CR: \>5% blasts in the bone marrow and/or peripheral blood. * Confirmation of relapse by bone marrow analysis with more than 10% blasts. * Extramedullary disease confirmed cytologically or histologically.
    time origin
    4 weeks after transplant
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants that received and completed study treatment
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00119366
    outcome key
    om-0003
    source section id
    NCT00119366-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: Severity of GVHD 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
    Study participants that completed study treatment
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00119366
    outcome key
    om-0004
    source section id
    NCT00119366-om-0004
    source outcome index
    4
    endpoint
    Number of Participants With 100% Donor Chimerism at Day 28 and Day 84
    endpoint definition
    Post-transplant bone marrow samples were collected on day 28 and day 84 after transplant for DNA Chimerism Analysis
    time origin
    Day 28 and Day 80 after transplant
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients that completed the study regimen
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00119366
    outcome key
    om-0005
    source section id
    NCT00119366-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 for 2 years after transplant 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 \>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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00119366
    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 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
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00119366-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00119366
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Dose Level 7: 22 Gy Iodine-131 + BC8 Monoclonal Antibody
    regimen
    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
    analyzed count
    2
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00119366-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00119366
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Dose Level 8: 24 Gy Iodine-131 + BC8
    regimen
    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
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00119366-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00119366
    outcome key
    om-0000
    arm key
    OG003
    arm label
    Dose Level 9: 26 Gy Iodine-131 + BC8
    regimen
    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
    analyzed count
    2
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00119366-om-0000#groups/OG003
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00119366
    outcome key
    om-0000
    arm key
    OG004
    arm label
    Dose Level 10: 28 Gy Iodine-131 + BC8
    regimen
    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
    analyzed count
    8
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00119366-om-0000#groups/OG004
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00119366
    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 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
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00119366-om-0001#groups/OG000
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00119366
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Dose Level 7: 22 Gy Iodine-131+ BC8 Monoclonal Antibody
    regimen
    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 studie
    analyzed count
    2
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00119366-om-0001#groups/OG001
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00119366
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Dose Level 8: 24 Gy Iodine-131+ BC8 Monoclonal Antibody
    regimen
    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 studie
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00119366-om-0001#groups/OG002
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00119366
    outcome key
    om-0001
    arm key
    OG003
    arm label
    Dose Level 9: 26 Gy Iodine-131+ BC8 Monoclonal Antibody
    regimen
    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 studie
    analyzed count
    2
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00119366-om-0001#groups/OG003
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00119366
    outcome key
    om-0001
    arm key
    OG004
    arm label
    Dose Level 10: 28 Gy Iodine-131+ BC8
    regimen
    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 studie
    analyzed count
    8
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00119366-om-0001#groups/OG004
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00119366
    outcome key
    om-0002
    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 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
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00119366-om-0002#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00119366
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Dose Level 7: 22 Gy Iodine-131 + BC8 Monoclonal Antibody
    regimen
    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
    analyzed count
    2
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00119366-om-0002#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00119366
    harm key
    EG000
    source section id
    NCT00119366-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
    0
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00119366
    harm key
    EG001
    source section id
    NCT00119366-ae
    event group key
    EG001
    event group label
    Dose Level 7: 22 Gy Iodine-131+ BC8 Monoclonal Antibody
    serious affected
    2
    serious at risk
    2
    other affected
    0
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00119366
    harm key
    EG002
    source section id
    NCT00119366-ae
    event group key
    EG002
    event group label
    Dose Level 8: 24 Gy Iodine-131+ BC8 Monoclonal Antibody
    serious affected
    3
    serious at risk
    3
    other affected
    1
    other at risk
    3
    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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00119366
    harm key
    EG003
    source section id
    NCT00119366-ae
    event group key
    EG003
    event group label
    Dose Level 9: 26 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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00119366
    harm key
    EG004
    source section id
    NCT00119366-ae
    event group key
    EG004
    event group label
    Dose Level 10: 28 Gy Iodine-131+ BC8 Monoclonal Antibody
    serious affected
    8
    serious at risk
    8
    other affected
    5
    other at risk
    8
    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