NCT01987596 · STUDY IN CONTEXT

Study of Fixed vs. Flexible Filgrastim to Accelerate Bone Marrow Recovery After Chemotherapy in Children With Cancer

Draft scope assessment: unclear. Attached because the study's own record describes recurrent 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

Time in days until absolute neutrophil count (ANC) recovery to greater than or equal to 1,000/uL from the start of chemotherapy

Source null

→

secondary · POSTED

occurrence of febrile neutropenia

Each patient server as his/her own control

→

secondary · POSTED

Cumulative GCSF dose - number of GCSF injections until ANC recovery greater than or equal to 1,000/uL from the start of chemotherapy

Patients who had data for period 2

→

secondary · POSTED

Time (in days) to first G-CSF dose

All participants with period 2 data

→

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-childhood-kidney-tumors-recurrent-d815659b
nct id: NCT01987596
trial label: Study of Fixed vs. Flexible Filgrastim to Accelerate Bone Marrow Recovery After Chemotherapy in Children With Cancer
applicability: unclear
applicability note: Attached because the study's own record describes recurrent 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: 4
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-childhood-kidney-tumors-recurrent-d815659b
nct id
NCT01987596
outcome key
om-0000
source section id
NCT01987596-om-0000
source outcome index
0
endpoint
Days to ANC Greater Than or Equal to 1,000/uL From the Start of Chemotherapy
endpoint definition
Time in days until absolute neutrophil count (ANC) recovery to greater than or equal to 1,000/uL from the start of chemotherapy
time origin
From the start of the course until the first date the ANC reaches >= 1,000/uL post nadir, assessed up to 1 year
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-childhood-kidney-tumors-recurrent-d815659b
nct id
NCT01987596
outcome key
om-0001
source section id
NCT01987596-om-0001
source outcome index
1
endpoint
Incidence of Febrile Neutropenia
endpoint definition
occurrence of febrile neutropenia
time origin
Up to 1 year
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Each patient server as his/her own control
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-childhood-kidney-tumors-recurrent-d815659b
nct id
NCT01987596
outcome key
om-0002
source section id
NCT01987596-om-0002
source outcome index
2
endpoint
Cumulative GCSF Dose
endpoint definition
Cumulative GCSF dose - number of GCSF injections until ANC recovery greater than or equal to 1,000/uL from the start of chemotherapy
time origin
up until engraftment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Patients who had data for period 2
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-childhood-kidney-tumors-recurrent-d815659b
nct id
NCT01987596
outcome key
om-0003
source section id
NCT01987596-om-0003
source outcome index
3
endpoint
Days to First G-CSF Dose
endpoint definition
Time (in days) to first G-CSF dose
time origin
time to ANC 1000
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All participants with period 2 data
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-childhood-kidney-tumors-recurrent-d815659b
nct id
NCT01987596
outcome key
om-0000
arm key
OG000
arm label
Fixed
regimen
Mean of time to ANC1000 during period participants were on fixed regimen
analyzed count
21
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01987596-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-childhood-kidney-tumors-recurrent-d815659b
nct id
NCT01987596
outcome key
om-0000
arm key
OG001
arm label
Flexible
regimen
Mean of time to ANC1000 during period participants were on flexible regimen
analyzed count
21
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01987596-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-childhood-kidney-tumors-recurrent-d815659b
nct id
NCT01987596
outcome key
om-0001
arm key
OG000
arm label
Fixed
regimen
Incidence duriing time patient was on fixed schedule
analyzed count
21
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01987596-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-childhood-kidney-tumors-recurrent-d815659b
nct id
NCT01987596
outcome key
om-0001
arm key
OG001
arm label
Flexible
regimen
Incidence duriing time patient was on flexible schedule
analyzed count
21
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01987596-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-childhood-kidney-tumors-recurrent-d815659b
nct id
NCT01987596
outcome key
om-0002
arm key
OG000
arm label
Fixed Filgrastim
regimen
Patients receive filgrastim daily SC QD started at 24 hours after completion of chemotherapy and stopped when ANC reaches at least 1,000/uL post nadir.
analyzed count
19
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01987596-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-childhood-kidney-tumors-recurrent-d815659b
nct id
NCT01987596
outcome key
om-0002
arm key
OG001
arm label
Flexible Filgrastim
regimen
Patients receive filgrastim SC QD started on the first day after chemotherapy and on any day ANC falls below 1,000/uL and stopped when ANC reaches at least 1,000/uL post nadir.
analyzed count
19
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01987596-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-childhood-kidney-tumors-recurrent-d815659b
nct id
NCT01987596
outcome key
om-0003
arm key
OG000
arm label
Arm I (Fixed Filgrastim)
regimen
Patients receive filgrastim SC QD started at 24 hours after completion of chemotherapy and continued daily until ANC reaches at least 1,000/uL post nadir.
analyzed count
19
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01987596-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-childhood-kidney-tumors-recurrent-d815659b
nct id
NCT01987596
outcome key
om-0003
arm key
OG001
arm label
Arm II (Flexible Filgrastim)
regimen
Patients receive filgrastim SC QD started on the first day after chemotherapy when ANC falls below 1,000/uL and stopped when ANC reaches at least 1,000/uL post nadir.
analyzed count
19
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01987596-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-childhood-kidney-tumors-recurrent-d815659b
nct id
NCT01987596
harm key
EG000
source section id
NCT01987596-ae
event group key
EG000
event group label
Arm I (Fixed Filgrastim)
serious affected
0
serious at risk
21
other affected
4
other at risk
21
frequency threshold
0
collection period
6 months
event definition
Nothing to mention
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-childhood-kidney-tumors-recurrent-d815659b
nct id
NCT01987596
harm key
EG001
source section id
NCT01987596-ae
event group key
EG001
event group label
Arm II (Flexible Filgrastim)
serious affected
0
serious at risk
21
other affected
1
other at risk
21
frequency threshold
0
collection period
6 months
event definition
Nothing to mention
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