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← refractory Myelodysplastic Syndromes

NCT00397813 · STUDY IN CONTEXT

Fludarabine Phosphate and Total Body Irradiation Followed by a Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndromes or Myeloproliferative Disor

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

HCT failure will be defined as graft rejection (defined as \< 5% donor T-cell chimerism) or disease progression within 200 days of transplant.

No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.

→

secondary · POSTED

Number of patients who experienced bacterial, fungal, or viral infections.

No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.

→

secondary · POSTED

Continued engraftment will be defined as the detection of donor T-cells (CD3+) as a proportion of the total T-cell of greater than 5%.

No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.

→

secondary · POSTED

Evidence of disease progression will be an indication for therapeutic intervention. Defined as any evidence by morphologic or flow cytometric evaluation of the bone marrow aspirate of an incremental increase in 5% blasts in MDS/CMML; defined as any evidence of blastic transformation in agnogenic myeloid metaplasia/atypical CML; and defined as progressive erythrocytosis, thrombocytosis, or evidence of leukemic transformation in polycythemia vera and essential thrombocythemia.

No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.

→

secondary · POSTED

Evidence of disease progression will be an indication for therapeutic intervention. Defined as any evidence by morphologic or flow cytometric evaluation of the bone marrow aspirate of an incremental increase in 5% blasts in MDS/CMML; defined as any evidence of blastic transformation in agnogenic myeloid metaplasia/atypical CML; and defined as progressive erythrocytosis, thrombocytosis, or evidence of leukemic transformation in polycythemia vera and essential thrombocythemia.

No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.

→

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
NCT00397813
trial label
Fludarabine Phosphate and Total Body Irradiation Followed by a Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndromes or Myeloproliferative Disor
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
5
harms Count
6
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00397813
    outcome key
    om-0000
    source section id
    NCT00397813-om-0000
    source outcome index
    0
    endpoint
    Number of Patients With HCT Failure.
    endpoint definition
    HCT failure will be defined as graft rejection (defined as \< 5% donor T-cell chimerism) or disease progression within 200 days of transplant.
    time origin
    200 days
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
    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
    NCT00397813
    outcome key
    om-0001
    source section id
    NCT00397813-om-0001
    source outcome index
    1
    endpoint
    Number of Patients Who Had Infections
    endpoint definition
    Number of patients who experienced bacterial, fungal, or viral infections.
    time origin
    1 year
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
    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
    NCT00397813
    outcome key
    om-0002
    source section id
    NCT00397813-om-0002
    source outcome index
    2
    endpoint
    Number of Patients Who Engrafted
    endpoint definition
    Continued engraftment will be defined as the detection of donor T-cells (CD3+) as a proportion of the total T-cell of greater than 5%.
    time origin
    1 year
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
    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
    NCT00397813
    outcome key
    om-0003
    source section id
    NCT00397813-om-0003
    source outcome index
    3
    endpoint
    Number of Patients With Progression-free Survival
    endpoint definition
    Evidence of disease progression will be an indication for therapeutic intervention. Defined as any evidence by morphologic or flow cytometric evaluation of the bone marrow aspirate of an incremental increase in 5% blasts in MDS/CMML; defined as any evidence of blastic transformation in agnogenic myeloid metaplasia/atypical CML; and defined as progressive erythrocytosis, thrombocytosis, or evidence of leukemic transformation in polycythemia vera and essential thrombocythemia.
    time origin
    1 year
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
    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
    NCT00397813
    outcome key
    om-0004
    source section id
    NCT00397813-om-0004
    source outcome index
    4
    endpoint
    Number of Patients With Relapse/Progression
    endpoint definition
    Evidence of disease progression will be an indication for therapeutic intervention. Defined as any evidence by morphologic or flow cytometric evaluation of the bone marrow aspirate of an incremental increase in 5% blasts in MDS/CMML; defined as any evidence of blastic transformation in agnogenic myeloid metaplasia/atypical CML; and defined as progressive erythrocytosis, thrombocytosis, or evidence of leukemic transformation in polycythemia vera and essential thrombocythemia.
    time origin
    1 year
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
    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
    NCT00397813
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm A - Dose Level 1
    regimen
    Arm A - patients with MPD or MDS-RA/RARS Dose Level 1 - 300 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
    analyzed count
    36
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00397813-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00397813
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm A - Dose Level 2
    regimen
    Arm A - patients with MPD or MDS-RA/RARS Dose Level 2 - 400 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00397813-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00397813
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Arm A - Dose Level 3
    regimen
    Arm A - patients with MPD or MDS-RA/RARS Dose Level 3 - 450 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00397813-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00397813
    outcome key
    om-0000
    arm key
    OG003
    arm label
    Arm B - Dose Level 1
    regimen
    Arm B - patients with MDS-RAEB or CMML Dose Level 1 - 300 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
    analyzed count
    12
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00397813-om-0000#groups/OG003
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00397813
    outcome key
    om-0000
    arm key
    OG004
    arm label
    Arm B - Dose Level 2
    regimen
    Arm B - patients with MDS-RAEB or CMML Dose Level 2 - 400 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
    analyzed count
    5
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00397813-om-0000#groups/OG004
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00397813
    outcome key
    om-0000
    arm key
    OG005
    arm label
    Arm B - Dose Level 3
    regimen
    Arm B - patients with MDS-RAEB or CMML Dose Level 3 - 450 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
    analyzed count
    24
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00397813-om-0000#groups/OG005
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00397813
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm A - Dose Level 1
    regimen
    Arm A - patients with MPD or MDS-RA/RARS Dose Level 1 - 300 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
    analyzed count
    36
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00397813-om-0001#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00397813
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Arm A - Dose Level 2
    regimen
    Arm A - patients with MPD or MDS-RA/RARS Dose Level 2 - 400 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00397813-om-0001#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00397813
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Arm A - Dose Level 3
    regimen
    Arm A - patients with MPD or MDS-RA/RARS Dose Level 3 - 450 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00397813-om-0001#groups/OG002
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00397813
    outcome key
    om-0001
    arm key
    OG003
    arm label
    Arm B - Dose Level 1
    regimen
    Arm B - patients with MDS-RAEB or CMML Dose Level 1 - 300 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
    analyzed count
    12
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00397813-om-0001#groups/OG003
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00397813
    outcome key
    om-0001
    arm key
    OG004
    arm label
    Arm B - Dose Level 2
    regimen
    Arm B - patients with MDS-RAEB or CMML Dose Level 2 - 400 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
    analyzed count
    5
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00397813-om-0001#groups/OG004
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00397813
    outcome key
    om-0001
    arm key
    OG005
    arm label
    Arm B - Dose Level 3
    regimen
    Arm B - patients with MDS-RAEB or CMML Dose Level 3 - 450 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
    analyzed count
    24
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00397813-om-0001#groups/OG005
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00397813
    harm key
    EG000
    source section id
    NCT00397813-ae
    event group key
    EG000
    event group label
    Arm A - Dose Level 1
    serious affected
    3
    serious at risk
    36
    other affected
    16
    other at risk
    36
    frequency threshold
    0
    collection period
    AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
    event definition
    No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
    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
    NCT00397813
    harm key
    EG001
    source section id
    NCT00397813-ae
    event group key
    EG001
    event group label
    Arm A - Dose Level 2
    serious affected
    0
    serious at risk
    0
    other affected
    0
    other at risk
    0
    frequency threshold
    0
    collection period
    AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
    event definition
    No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
    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
    NCT00397813
    harm key
    EG002
    source section id
    NCT00397813-ae
    event group key
    EG002
    event group label
    Arm A - Dose Level 3
    serious affected
    0
    serious at risk
    0
    other affected
    0
    other at risk
    0
    frequency threshold
    0
    collection period
    AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
    event definition
    No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
    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
    NCT00397813
    harm key
    EG003
    source section id
    NCT00397813-ae
    event group key
    EG003
    event group label
    Arm B - Dose Level 1
    serious affected
    7
    serious at risk
    12
    other affected
    9
    other at risk
    12
    frequency threshold
    0
    collection period
    AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
    event definition
    No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
    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
    NCT00397813
    harm key
    EG004
    source section id
    NCT00397813-ae
    event group key
    EG004
    event group label
    Arm B - Dose Level 2
    serious affected
    2
    serious at risk
    5
    other affected
    2
    other at risk
    5
    frequency threshold
    0
    collection period
    AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
    event definition
    No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
    undenominated note
    Source null
    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
    NCT00397813
    harm key
    EG005
    source section id
    NCT00397813-ae
    event group key
    EG005
    event group label
    Arm B - Dose Level 3
    serious affected
    4
    serious at risk
    24
    other affected
    13
    other at risk
    24
    frequency threshold
    0
    collection period
    AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
    event definition
    No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
    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