NCT01858740 · STUDY IN CONTEXT

Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts in Preventing GVHD in Children

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.

primary · POSTED

Graft failure defined as failure to reach ANC of \>500/uL for 3 consecutive days by day 28, or irreversible decrease in ANC to \<100 after an established donor graft. A reduction in ANC as result of relapse is not considered graft failure

Source null

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primary · POSTED

Measure the number of days to discontinuation of systemic immunosuppression (both including and excluding calcineurin inhibitors) in pediatric recipients of CD45RA+ T cell-depleted PBSCT. Possible outcomes range from no systemic immunosuppression (best outcome) to 5 years on immunosuppression (poor outcome)

Source null

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secondary · POSTED

Number of days post-transplant without transfusion where platelet count is \>50,000/uL. Measured as the first of three days

Source null

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secondary · POSTED

Number of days post transplant until platelet count is \>20,000/uL for three consecutive days without transfusion, counted as the first of three days

Source null

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secondary · POSTED

Time (in days) to ANC of \> 1,000/uL, counted as the first of three consecutive days post-transplant

Source null

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secondary · POSTED

Time (in days) to ANC of \> 500/uL, counted as the first of three consecutive days post-transplant

Source null

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Reported safety

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

Open the study safety table →

Quality of life and patient-reported measures

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

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-acute-undifferentiated-leukemia
nct id: NCT01858740
trial label: Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts in Preventing GVHD in Children
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: 6
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-acute-undifferentiated-leukemia
nct id
NCT01858740
outcome key
om-0000
source section id
NCT01858740-om-0000
source outcome index
0
endpoint
Graft Failure
endpoint definition
Graft failure defined as failure to reach ANC of \>500/uL for 3 consecutive days by day 28, or irreversible decrease in ANC to \<100 after an established donor graft. A reduction in ANC as result of relapse is not considered graft failure
time origin
Up to 5 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-undifferentiated-leukemia
nct id
NCT01858740
outcome key
om-0001
source section id
NCT01858740-om-0001
source outcome index
1
endpoint
Time to Discontinuation of Systemic Immunosuppression
endpoint definition
Measure the number of days to discontinuation of systemic immunosuppression (both including and excluding calcineurin inhibitors) in pediatric recipients of CD45RA+ T cell-depleted PBSCT. Possible outcomes range from no systemic immunosuppression (best outcome) to 5 years on immunosuppression (poor outcome)
time origin
5 years post transplant
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-undifferentiated-leukemia
nct id
NCT01858740
outcome key
om-0002
source section id
NCT01858740-om-0002
source outcome index
2
endpoint
Time to Platelet Count > 50,000/uL for 3 Days Without Transfusion
endpoint definition
Number of days post-transplant without transfusion where platelet count is \>50,000/uL. Measured as the first of three days
time origin
Up to 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-undifferentiated-leukemia
nct id
NCT01858740
outcome key
om-0003
source section id
NCT01858740-om-0003
source outcome index
3
endpoint
Time to Platelet Count > 20,000/uL for 3 Days Without Transfusion
endpoint definition
Number of days post transplant until platelet count is \>20,000/uL for three consecutive days without transfusion, counted as the first of three days
time origin
Up to 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-undifferentiated-leukemia
nct id
NCT01858740
outcome key
om-0004
source section id
NCT01858740-om-0004
source outcome index
4
endpoint
Time to ANC of > 1,000/uL
endpoint definition
Time (in days) to ANC of \> 1,000/uL, counted as the first of three consecutive days post-transplant
time origin
Up to 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-undifferentiated-leukemia
nct id
NCT01858740
outcome key
om-0005
source section id
NCT01858740-om-0005
source outcome index
5
endpoint
Time to ANC of > 500/uL
endpoint definition
Time (in days) to ANC of \> 500/uL, counted as the first of three consecutive days post-transplant
time origin
Up to 5 years
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

release id
clinical-indications-draft-1
disease state id
ds-acute-undifferentiated-leukemia
nct id
NCT01858740
outcome key
om-0000
arm key
OG000
arm label
Overall Study Participants
regimen
All participants in single arm study received CD45RA+ T cell depletion PBSC transplant and IV Methotrexate and tacrolimus for GVHD prophylaxis
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01858740-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-undifferentiated-leukemia
nct id
NCT01858740
outcome key
om-0001
arm key
OG000
arm label
Overall Study Patients Alive at D100
regimen
All participants in single arm study of CD45RA+ T cell depletion PBSC transplant and Methotrexate and tacrolimus for GVHD prophylaxis that were alive at D100
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01858740-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-undifferentiated-leukemia
nct id
NCT01858740
outcome key
om-0002
arm key
OG000
arm label
Overall Study Participants
regimen
All participants in single arm study received CD45RA+ T cell depletion PBSC transplant and IV Methotrexate and tacrolimus for GVHD prophylaxis
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01858740-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-undifferentiated-leukemia
nct id
NCT01858740
outcome key
om-0003
arm key
OG000
arm label
Overall Study Participants
regimen
All participants in single arm study received CD45RA+ T cell depletion PBSC transplant and IV Methotrexate and tacrolimus for GVHD prophylaxis
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01858740-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-undifferentiated-leukemia
nct id
NCT01858740
outcome key
om-0004
arm key
OG000
arm label
Overall Study Participants
regimen
All participants in single arm study received CD45RA+ T cell depletion PBSC transplant and IV Methotrexate and tacrolimus for GVHD prophylaxis
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01858740-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-undifferentiated-leukemia
nct id
NCT01858740
outcome key
om-0005
arm key
OG000
arm label
Overall Study Participants
regimen
All participants in single arm study received CD45RA+ T cell depletion PBSC transplant and IV Methotrexate and tacrolimus for GVHD prophylaxis
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01858740-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-acute-undifferentiated-leukemia
nct id
NCT01858740
harm key
EG000
source section id
NCT01858740-ae
event group key
EG000
event group label
Treatment (CD45RA+ T Cell Depleted PBSCT)
serious affected
0
serious at risk
20
other affected
20
other at risk
20
frequency threshold
0
collection period
AEs and SAEs: Conditioning through D100; All cause mortality: Conditioning through 5 year
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