NCT00103610 · STUDY IN CONTEXT

Mobilization of Stem Cells With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma Patients

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 because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

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

Proportion of participants achieving a target of ≥ 5\*10\^6 CD34+ cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.

Intent-to-Treat Population

→

secondary · POSTED

Number of participants with treatment emergent adverse events (AEs). The timeframe for treatment emergent AEs is defined as Day 1 (start of G-CSF Mobilization) to the day before starting chemotherapy (approximately 38 days later). AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale. AEs of Grade 3 were considered severe and Grade 4 were considered life-threatening.

Safety population of all participants who received at least 1 mobilization dose of G-CSF or study treatment (plerixafor or placebo). Three participants did not receive G-CSF or any study treatment and were excluded from the safety analyses.

→

secondary · POSTED

Proportion of participants achieving a target of \>=2\*10\^6 CD34+ Cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.

Intent-to-treat Population

→

secondary · POSTED

The Kaplan Meier estimate of median number of days (number of days at which 50% of participants reached the threshold, accounting for censored values) in each treatment arm to collect the target number of cells (≥5\*10\^6 CD34+ cells/kg) for transplantation. Central laboratory values were used.

Intent-to-Treat Population.

→

secondary · POSTED

The Kaplan Meier estimate of median number of days to PMN engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as PMN counts ≥ 0.5\10\^9/L for 3 consecutive days or ≥ 1.0\10\^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met.

Participants who received a stem cell transplant.

→

secondary · POSTED

The Kaplan Meier estimate of median number of days to PLT engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as ≥ 20\*10\^9/L without transfusion for the preceding 7 days. Time to engraftment corresponded to the first day that the criteria were met.

Participants who received a stem cell 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-non-hodgkin-lymphoma
nct id: NCT00103610
trial label: Mobilization of Stem Cells With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma Patients
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: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma
nct id
NCT00103610
outcome key
om-0000
source section id
NCT00103610-om-0000
source outcome index
0
endpoint
Proportion of Participants Able to Achieve Target (≥ 5*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis
endpoint definition
Proportion of participants achieving a target of ≥ 5\*10\^6 CD34+ cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.
time origin
Days 5 to 8
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Intent-to-Treat Population
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-non-hodgkin-lymphoma
nct id
NCT00103610
outcome key
om-0001
source section id
NCT00103610-om-0001
source outcome index
1
endpoint
Number of Participants With Adverse Events
endpoint definition
Number of participants with treatment emergent adverse events (AEs). The timeframe for treatment emergent AEs is defined as Day 1 (start of G-CSF Mobilization) to the day before starting chemotherapy (approximately 38 days later). AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale. AEs of Grade 3 were considered severe and Grade 4 were considered life-threatening.
time origin
up to Day 38
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Safety population of all participants who received at least 1 mobilization dose of G-CSF or study treatment (plerixafor or placebo). Three participants did not receive G-CSF or any study treatment and were excluded from the safety analyses.
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-non-hodgkin-lymphoma
nct id
NCT00103610
outcome key
om-0002
source section id
NCT00103610-om-0002
source outcome index
2
endpoint
Proportion of Participants Able to Achieve Target (>=2*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis
endpoint definition
Proportion of participants achieving a target of \>=2\*10\^6 CD34+ Cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.
time origin
up to Day 8
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Intent-to-treat Population
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-non-hodgkin-lymphoma
nct id
NCT00103610
outcome key
om-0003
source section id
NCT00103610-om-0003
source outcome index
3
endpoint
Median Number of Days of Apheresis Required to Achieve >=5*10^6 CD34+ Cells/kg
endpoint definition
The Kaplan Meier estimate of median number of days (number of days at which 50% of participants reached the threshold, accounting for censored values) in each treatment arm to collect the target number of cells (≥5\*10\^6 CD34+ cells/kg) for transplantation. Central laboratory values were used.
time origin
up to Day 8
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Intent-to-Treat Population.
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-non-hodgkin-lymphoma
nct id
NCT00103610
outcome key
om-0004
source section id
NCT00103610-om-0004
source outcome index
4
endpoint
Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment
endpoint definition
The Kaplan Meier estimate of median number of days to PMN engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as PMN counts ≥ 0.5\*10\^9/L for 3 consecutive days or ≥ 1.0\*10\^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met.
time origin
Up to Month 13
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants who received a stem cell transplant.
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-non-hodgkin-lymphoma
nct id
NCT00103610
outcome key
om-0005
source section id
NCT00103610-om-0005
source outcome index
5
endpoint
Median Number of Days to Platelet (PLT) Engraftment
endpoint definition
The Kaplan Meier estimate of median number of days to PLT engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as ≥ 20\*10\^9/L without transfusion for the preceding 7 days. Time to engraftment corresponded to the first day that the criteria were met.
time origin
Up to Month 13
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants who received a stem cell transplant
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-non-hodgkin-lymphoma
nct id
NCT00103610
outcome key
om-0000
arm key
OG000
arm label
G-CSF Plus Plerixafor
regimen
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
analyzed count
150
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00103610-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma
nct id
NCT00103610
outcome key
om-0000
arm key
OG001
arm label
G-CSF Plus Placebo
regimen
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
analyzed count
148
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00103610-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma
nct id
NCT00103610
outcome key
om-0001
arm key
OG000
arm label
G-CSF Plus Plerixafor
regimen
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
analyzed count
150
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00103610-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma
nct id
NCT00103610
outcome key
om-0001
arm key
OG001
arm label
G-CSF Plus Placebo
regimen
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
analyzed count
145
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00103610-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma
nct id
NCT00103610
outcome key
om-0002
arm key
OG000
arm label
G-CSF Plus Plerixafor
regimen
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
analyzed count
150
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00103610-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma
nct id
NCT00103610
outcome key
om-0002
arm key
OG001
arm label
G-CSF Plus Placebo
regimen
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
analyzed count
148
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00103610-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma
nct id
NCT00103610
outcome key
om-0003
arm key
OG000
arm label
G-CSF + Plerixafor
regimen
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
analyzed count
147
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00103610-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma
nct id
NCT00103610
outcome key
om-0003
arm key
OG001
arm label
G-CSF Plus Placebo
regimen
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
analyzed count
142
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00103610-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma
nct id
NCT00103610
outcome key
om-0004
arm key
OG000
arm label
G-CSF Plus Plerixafor
regimen
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
analyzed count
135
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00103610-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma
nct id
NCT00103610
outcome key
om-0004
arm key
OG001
arm label
G-CSF Plus Placebo
regimen
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
analyzed count
82
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00103610-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma
nct id
NCT00103610
outcome key
om-0005
arm key
OG000
arm label
G-CSF Plus Plerixafor
regimen
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
analyzed count
135
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00103610-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma
nct id
NCT00103610
outcome key
om-0005
arm key
OG001
arm label
G-CSF Plus Placebo
regimen
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
analyzed count
82
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00103610-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma
nct id
NCT00103610
harm key
EG000
source section id
NCT00103610-ae
event group key
EG000
event group label
G-CSF Plus Plerixafor
serious affected
8
serious at risk
150
other affected
145
other at risk
150
frequency threshold
0
collection period
Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38).
event definition
Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
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-non-hodgkin-lymphoma
nct id
NCT00103610
harm key
EG001
source section id
NCT00103610-ae
event group key
EG001
event group label
G-CSF Plus Placebo
serious affected
10
serious at risk
145
other affected
136
other at risk
145
frequency threshold
0
collection period
Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38).
event definition
Three participants did not receive any study treatment and were excluded from the safety analyses. In the event a participant experienced both a serious and a non-serious form of the same AE, they were included in the numerator of both AE tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
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