NCT01233921 · STUDY IN CONTEXT

Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer

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

RTE CD4 T cells will be defined according to co-expression of CD3, CD4, CD31, CD45RA, and CCR7. Cells will be counted by flow cytometry at baseline and at 4 weeks and changes will be measured as cells per microliter of blood. Positive results indicate an increase in the number of cells between baseline and 4 weeks. Negative results indicate a decrease in the number of cells between baseline and 4 weeks.

Source null

→

secondary · POSTED

Naive CD4 T cells will be defined according to co-expression of CD3, CD4, CD45RA, and CCR7. Positive results indicate an increase in the number of cells between baseline and 4 weeks. Negative results indicate a decrease in the number of cells between baseline and 4 weeks.

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-hairy-cell-leukemia
nct id: NCT01233921
trial label: Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer
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: 2
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-hairy-cell-leukemia
nct id
NCT01233921
outcome key
om-0000
source section id
NCT01233921-om-0000
source outcome index
0
endpoint
Changes in the Number of Recent Thymic Emigrants (RTE) Cluster of Differentiation (CD)4 T Cells in the Blood
endpoint definition
RTE CD4 T cells will be defined according to co-expression of CD3, CD4, CD31, CD45RA, and CCR7. Cells will be counted by flow cytometry at baseline and at 4 weeks and changes will be measured as cells per microliter of blood. Positive results indicate an increase in the number of cells between baseline and 4 weeks. Negative results indicate a decrease in the number of cells between baseline and 4 weeks.
time origin
Baseline and 4 weeks after administration of palifermin
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-hairy-cell-leukemia
nct id
NCT01233921
outcome key
om-0001
source section id
NCT01233921-om-0001
source outcome index
1
endpoint
Changes in the Number of Naive CD4 T Cells in the Blood
endpoint definition
Naive CD4 T cells will be defined according to co-expression of CD3, CD4, CD45RA, and CCR7. Positive results indicate an increase in the number of cells between baseline and 4 weeks. Negative results indicate a decrease in the number of cells between baseline and 4 weeks.
time origin
Baseline and 4 weeks after administration of palifermin
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-hairy-cell-leukemia
nct id
NCT01233921
outcome key
om-0000
arm key
OG000
arm label
Arm I (Palifermin)
regimen
Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01233921-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-hairy-cell-leukemia
nct id
NCT01233921
outcome key
om-0000
arm key
OG001
arm label
Arm II (no Palifermin)
regimen
Patients do not receive palifermin.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01233921-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-hairy-cell-leukemia
nct id
NCT01233921
outcome key
om-0001
arm key
OG000
arm label
Arm I (Palifermin)
regimen
Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01233921-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-hairy-cell-leukemia
nct id
NCT01233921
outcome key
om-0001
arm key
OG001
arm label
Arm II (no Palifermin)
regimen
Patients do not receive palifermin.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01233921-om-0001#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-hairy-cell-leukemia
nct id
NCT01233921
harm key
EG000
source section id
NCT01233921-ae
event group key
EG000
event group label
Arm I (Palifermin)
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Source null
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
release id
clinical-indications-draft-1
disease state id
ds-hairy-cell-leukemia
nct id
NCT01233921
harm key
EG001
source section id
NCT01233921-ae
event group key
EG001
event group label
Arm II (no Palifermin)
serious affected
0
serious at risk
3
other affected
2
other at risk
3
frequency threshold
5
collection period
Source null
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