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← refractory Myelodysplastic Syndromes

NCT00354172 · STUDY IN CONTEXT

Donor Umbilical Cord Blood Natural Killer Cells, Aldesleukin and Umbilical Cord Blood Transplant in Patients With Refractory Hematologic Cancers.

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

Number of patients who were alive and free of disease (malignancy) at 6 months after transplant.

One patient did not receive umbilical cord transplant and was not included in this Evaluable patient group.

→

secondary · POSTED

Number of patients who were alive and free of disease (malignancy) at 12 months after transplant.

Source null

→

secondary · POSTED

Number of patients who were alive and free of disease (malignancy) at 24 months after transplant.

Source null

→

secondary · POSTED

Patients who had transplant-related mortality (TRM). TRM = adverse event(s) that occur(s) after the patient has received a transplant, the principal investigator decides it is related to the procedure and the patient dies within 6 months.

Source null

→

secondary · POSTED

Defined as absolute neutrophils (ANC) \> 5 x 10\^8/Liter for 3 consecutive days. ANC is the real number of white blood cells (WBCs) that are neutrophils. The absolute neutrophil count is commonly called the ANC. The ANC is not measured directly. It is derived by multiplying the WBC count times the percent of neutrophils in the differential WBC count. The percent of neutrophils consists of the segmented (fully mature) neutrophils) + the bands (almost mature neutrophils). The normal range for the ANC = 1.5 to 8.0 (1,500 to 8,000/mm3).

Source null

→

secondary · POSTED

Platelet engraftment is defined as platelet counts \> 50 x 10\^9/Liter for 3 consecutive days.

Source null

→

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
NCT00354172
trial label
Donor Umbilical Cord Blood Natural Killer Cells, Aldesleukin and Umbilical Cord Blood Transplant in Patients With Refractory Hematologic Cancers.
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
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00354172
    outcome key
    om-0000
    source section id
    NCT00354172-om-0000
    source outcome index
    0
    endpoint
    Number of Participants (Patients) Who Were Disease-free and Alive at 6 Months
    endpoint definition
    Number of patients who were alive and free of disease (malignancy) at 6 months after transplant.
    time origin
    6 Months Post Transplant
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    One patient did not receive umbilical cord transplant and was not included in this Evaluable patient group.
    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
    NCT00354172
    outcome key
    om-0001
    source section id
    NCT00354172-om-0001
    source outcome index
    1
    endpoint
    Number of Participants (Patients) Who Were Disease-free and Alive at 12 Months
    endpoint definition
    Number of patients who were alive and free of disease (malignancy) at 12 months after transplant.
    time origin
    12 Months 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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00354172
    outcome key
    om-0002
    source section id
    NCT00354172-om-0002
    source outcome index
    2
    endpoint
    Number of Patients Who Were Disease-free and Alive at 24 Months
    endpoint definition
    Number of patients who were alive and free of disease (malignancy) at 24 months after transplant.
    time origin
    24 Months 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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00354172
    outcome key
    om-0003
    source section id
    NCT00354172-om-0003
    source outcome index
    3
    endpoint
    Number of Participants (Patients) Who Died Due to Transplant.
    endpoint definition
    Patients who had transplant-related mortality (TRM). TRM = adverse event(s) that occur(s) after the patient has received a transplant, the principal investigator decides it is related to the procedure and the patient dies within 6 months.
    time origin
    6 Months 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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00354172
    outcome key
    om-0004
    source section id
    NCT00354172-om-0004
    source outcome index
    4
    endpoint
    Number of Participants (Patients) Who Attained Neutrophil Engraftment
    endpoint definition
    Defined as absolute neutrophils (ANC) \> 5 x 10\^8/Liter for 3 consecutive days. ANC is the real number of white blood cells (WBCs) that are neutrophils. The absolute neutrophil count is commonly called the ANC. The ANC is not measured directly. It is derived by multiplying the WBC count times the percent of neutrophils in the differential WBC count. The percent of neutrophils consists of the segmented (fully mature) neutrophils) + the bands (almost mature neutrophils). The normal range for the ANC = 1.5 to 8.0 (1,500 to 8,000/mm3).
    time origin
    Day 42 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
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00354172
    outcome key
    om-0005
    source section id
    NCT00354172-om-0005
    source outcome index
    5
    endpoint
    Number of Participants (Patients) Who Attained Platelet Engraftment
    endpoint definition
    Platelet engraftment is defined as platelet counts \> 50 x 10\^9/Liter for 3 consecutive days.
    time origin
    1 Year 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
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00354172
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Evaluable Patients
    regimen
    All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
    analyzed count
    15
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00354172-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00354172
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Evaluable Patients
    regimen
    All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
    analyzed count
    15
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00354172-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00354172
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Evaluable Patients
    regimen
    All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
    analyzed count
    15
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00354172-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00354172
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Evaluable Patients
    regimen
    All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
    analyzed count
    15
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00354172-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00354172
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Evaluable Patients
    regimen
    All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
    analyzed count
    15
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00354172-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00354172
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Evaluable Patients
    regimen
    All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
    analyzed count
    15
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00354172-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-syndromes-refractory-a84ec8fd
    nct id
    NCT00354172
    harm key
    EG000
    source section id
    NCT00354172-ae
    event group key
    EG000
    event group label
    Patients Treated for Refractory Hematologic Cancers
    serious affected
    16
    serious at risk
    16
    other affected
    0
    other at risk
    0
    frequency threshold
    5
    collection period
    Serious adverse events were collected if deemed related to treatment from Day 1 through 1 year post transplant. It was expected that most treatment related adverse events would occur during this period.
    event definition
    Only serious adverse events were captured for this study.
    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