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← Myelodysplastic/Myeloproliferative Neoplasms

NCT00025662 · STUDY IN CONTEXT

Selective T-Cell Depletion to Reduce GVHD (Patients) Receiving Stem Cell Tx to Treat Leukemia, Lymphoma or MDS

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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.

exploratory · POSTED

Proportion of patients with acute GVHD, grade 1 to 4

All 22 subjects who received the selectively depleted transplant

→

exploratory · POSTED

Acute GVHD (Grade 3 or 4) Using the CIBMTR Grading System.

All 22 patients who received the selectively depleted transplant

→

primary · POSTED

Nonrelapse mortality in the first 100 days of transplant expressed as a percentage of the total subjects. This is different from outcome measure 3 (Cumulative Nonrelapse Mortality), which is cumulative non relapse mortality till December 2011.

all 22 patients who received a selectively depleted allogeneic transplant, including one who was a special exemption for not meeting full eligibility criteria

→

secondary · POSTED

Percent overall survival (actuarial) at analysis in Dec 2011.

all patients who received the selectively depleted transplant including one special exemption

→

secondary · POSTED

Percent non relapse mortality (actuarial) at analysis in Dec 2011

All patients who received the selectively depleted 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-myeloproliferative-neoplasms
nct id
NCT00025662
trial label
Selective T-Cell Depletion to Reduce GVHD (Patients) Receiving Stem Cell Tx to Treat Leukemia, Lymphoma or MDS
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-myeloproliferative-neoplasms
    nct id
    NCT00025662
    outcome key
    om-0003
    source section id
    NCT00025662-om-0003
    source outcome index
    3
    endpoint
    Acute GVHD (Any Grade) Using the CIBMTR Grading System.
    endpoint definition
    Proportion of patients with acute GVHD, grade 1 to 4
    time origin
    100 days from transplant
    analysis role
    exploratory
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All 22 subjects who received the selectively depleted transplant
    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-myeloproliferative-neoplasms
    nct id
    NCT00025662
    outcome key
    om-0004
    source section id
    NCT00025662-om-0004
    source outcome index
    4
    endpoint
    Acute GVHD (Grade 3 or 4) Using the CIBMTR Grading System.
    endpoint definition
    Acute GVHD (Grade 3 or 4) Using the CIBMTR Grading System.
    time origin
    100 days from transplant
    analysis role
    exploratory
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All 22 patients who received the selectively depleted 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-myeloproliferative-neoplasms
    nct id
    NCT00025662
    outcome key
    om-0000
    source section id
    NCT00025662-om-0000
    source outcome index
    0
    endpoint
    Treatment-related Mortality
    endpoint definition
    Nonrelapse mortality in the first 100 days of transplant expressed as a percentage of the total subjects. This is different from outcome measure 3 (Cumulative Nonrelapse Mortality), which is cumulative non relapse mortality till December 2011.
    time origin
    100 days after stem cell infusion
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    all 22 patients who received a selectively depleted allogeneic transplant, including one who was a special exemption for not meeting full eligibility criteria
    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-myeloproliferative-neoplasms
    nct id
    NCT00025662
    outcome key
    om-0001
    source section id
    NCT00025662-om-0001
    source outcome index
    1
    endpoint
    Overall Survival
    endpoint definition
    Percent overall survival (actuarial) at analysis in Dec 2011.
    time origin
    Dec 2011.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    all patients who received the selectively depleted transplant including one special exemption
    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-myeloproliferative-neoplasms
    nct id
    NCT00025662
    outcome key
    om-0002
    source section id
    NCT00025662-om-0002
    source outcome index
    2
    endpoint
    Cumulative Non Relapse Mortality
    endpoint definition
    Percent non relapse mortality (actuarial) at analysis in Dec 2011
    time origin
    Dec 2011.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All patients who received the selectively depleted 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-myeloproliferative-neoplasms
    nct id
    NCT00025662
    outcome key
    om-0000
    arm key
    OG000
    arm label
    RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants
    regimen
    Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
    analyzed count
    22
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00025662-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-myeloproliferative-neoplasms
    nct id
    NCT00025662
    outcome key
    om-0001
    arm key
    OG000
    arm label
    RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants
    regimen
    Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
    analyzed count
    22
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00025662-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-myeloproliferative-neoplasms
    nct id
    NCT00025662
    outcome key
    om-0002
    arm key
    OG000
    arm label
    RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants
    regimen
    Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
    analyzed count
    22
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00025662-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-myeloproliferative-neoplasms
    nct id
    NCT00025662
    outcome key
    om-0003
    arm key
    OG000
    arm label
    RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants
    regimen
    Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
    analyzed count
    22
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00025662-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-myeloproliferative-neoplasms
    nct id
    NCT00025662
    outcome key
    om-0004
    arm key
    OG000
    arm label
    RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants
    regimen
    Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
    analyzed count
    22
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00025662-om-0004#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myelodysplastic-myeloproliferative-neoplasms
    nct id
    NCT00025662
    harm key
    EG000
    source section id
    NCT00025662-ae
    event group key
    EG000
    event group label
    RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants
    serious affected
    22
    serious at risk
    22
    other affected
    0
    other at risk
    22
    frequency threshold
    5
    collection period
    The adverse event reporting was collected for 7 years.
    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