Trial · NCT00103610

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

NCT00103610, Phase 3, Completed, Genzyme, a Sanofi Company; results first posted 2010-09-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Mobilization of Stem Cells With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma Patients. Trials, record NCT00103610. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00103610

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Mobilization of Stem Cells With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma Patients
NCT number: NCT00103610
Status: Completed
Phases: Phase 3
Enrollment: 298 participants, actual
Lead sponsor: Genzyme, a Sanofi Company
Conditions: Lymphoma, Non-Hodgkin
Interventions: Granulocyte colony-stimulating factor plus plerixafor, Granulocyte colony-stimulating factor plus placebo
First posted: 2005-02-14
Last updated: 2014-03-13
Results first posted: 2010-09-29

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Proportion of Participants Able to Achieve Target (≥ 5*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis	Days 5 to 8	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.
Secondary	Number of Participants With Adverse Events	up to Day 38	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.
Secondary	Proportion of Participants Able to Achieve Target (>=2*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis	up to Day 8	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.
Secondary	Median Number of Days of Apheresis Required to Achieve >=5*10^6 CD34+ Cells/kg	up to Day 8	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.
Secondary	Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment	Up to Month 13	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.
Secondary	Median Number of Days to Platelet (PLT) Engraftment	Up to Month 13	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.
Secondary	Graft Durability at 100 Days Post Transplantation	approximately Day 138	The proportion of participants maintaining a durable graft at 100 days post transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count \>50000/µL without transfusion for at least 2 weeks, (2) hemoglobin \>=10g/dL for at least 1 month, (3) and absolute neutrophil count \>1000/µL for at least 1 week.
Secondary	Graft Durability at 6 Months Post Transplantation	approximately Month 7	The proportion of participants maintaining a durable graft at 6 months post transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count \>50000/µL without transfusion for at least 2 weeks, (2) hemoglobin \>=10g/dL for at least 1 month, (3) and absolute neutrophil count \>1000/µL for at least 1 week.
Secondary	Graft Durability at 12 Months Post Transplantation	approximately Month 13	The proportion of participants maintaining a durable graft 12 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count \>50000/µL without transfusion for at least 2 weeks, (2) hemoglobin \>=10g/dL for at least 1 month, (3) and absolute neutrophil count \>1000/µL for at least 1 week.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Proportion of Participants Able to Achieve Target (≥ 5*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis	Days 5 to 8	Intent-to-Treat Population	proportion of participants	NUMBER
SECONDARY	Number of Participants With Adverse Events	up to Day 38	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.	participants	NUMBER
SECONDARY	Proportion of Participants Able to Achieve Target (>=2*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis	up to Day 8	Intent-to-treat Population	proportion of participants	NUMBER
SECONDARY	Median Number of Days of Apheresis Required to Achieve >=5*10^6 CD34+ Cells/kg	up to Day 8	Intent-to-Treat Population.	Days	MEDIAN
SECONDARY	Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment	Up to Month 13	Participants who received a stem cell transplant.	Days	MEDIAN
SECONDARY	Median Number of Days to Platelet (PLT) Engraftment	Up to Month 13	Participants who received a stem cell transplant	Days	MEDIAN
SECONDARY	Graft Durability at 100 Days Post Transplantation	approximately Day 138	Participants who received a stem cell transplant and were evaluable at 100 days post-transplant	proportion of participants	NUMBER
SECONDARY	Graft Durability at 6 Months Post Transplantation	approximately Month 7	Participants who received a stem cell transplant and were evaluable at 6 months post-transplant	proportion of participants	NUMBER
SECONDARY	Graft Durability at 12 Months Post Transplantation	approximately Month 13	Participants who received a stem cell transplant and were evaluable at 12 months post-transplant	proportion of participants	NUMBER

Source ClinicalTrials.gov

Results by group38

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Proportion of Participants Able to Achieve Target (≥ 5*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis	G-CSF Plus Plerixafor	Proportion achieving target in ≤4 days	0.593	proportion of participants
Proportion of Participants Able to Achieve Target (≥ 5*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis	G-CSF Plus Placebo	Proportion achieving target in ≤4 days	0.196	proportion of participants
Proportion of Participants Able to Achieve Target (≥ 5*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis	G-CSF Plus Plerixafor	Proportion not achieving target in ≤4 days	0.407	proportion of participants
Proportion of Participants Able to Achieve Target (≥ 5*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis	G-CSF Plus Placebo	Proportion not achieving target in ≤4 days	0.804	proportion of participants
Number of Participants With Adverse Events	G-CSF Plus Plerixafor	Adverse Events (AEs)	146	participants
Number of Participants With Adverse Events	G-CSF Plus Placebo	Adverse Events (AEs)	138	participants
Number of Participants With Adverse Events	G-CSF Plus Plerixafor	Related AEs	98	participants
Number of Participants With Adverse Events	G-CSF Plus Placebo	Related AEs	60	participants
Number of Participants With Adverse Events	G-CSF Plus Plerixafor	AEs Leading to early treatment termination	3	participants
Number of Participants With Adverse Events	G-CSF Plus Placebo	AEs Leading to early treatment termination	3	participants

1 to 10 of 38Source ClinicalTrials.gov

See all 38 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	G-CSF Plus Plerixafor	150
Overall Study	STARTED	G-CSF Plus Placebo	148
Overall Study	COMPLETED	G-CSF Plus Plerixafor	112
Overall Study	COMPLETED	G-CSF Plus Placebo	68
Overall Study	NOT COMPLETED	G-CSF Plus Plerixafor	38
Overall Study	NOT COMPLETED	G-CSF Plus Placebo	80

Source ClinicalTrials.gov

Adverse events518

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	G-CSF Plus Plerixafor	3	150
other	Anaemia	Blood and lymphatic system disorders	G-CSF Plus Placebo	5	145
other	Lymphadenopathy	Blood and lymphatic system disorders	G-CSF Plus Plerixafor	1	150
other	Lymphadenopathy	Blood and lymphatic system disorders	G-CSF Plus Placebo	2	145
other	Thrombocytopenia	Blood and lymphatic system disorders	G-CSF Plus Plerixafor	5	150
other	Thrombocytopenia	Blood and lymphatic system disorders	G-CSF Plus Placebo	5	145
other	Angina pectoris	Cardiac disorders	G-CSF Plus Plerixafor	0	150
other	Angina pectoris	Cardiac disorders	G-CSF Plus Placebo	1	145
other	Arrhythmia	Cardiac disorders	G-CSF Plus Plerixafor	0	150
other	Arrhythmia	Cardiac disorders	G-CSF Plus Placebo	1	145

1 to 10 of 518Source ClinicalTrials.gov

See all 518 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	G-CSF Plus Plerixafor
Total, all-cause mortality	G-CSF Plus Placebo
Total, other adverse events	G-CSF Plus Plerixafor	145	150
Total, other adverse events	G-CSF Plus Placebo	136	145
Total, serious adverse events	G-CSF Plus Plerixafor	8	150
Total, serious adverse events	G-CSF Plus Placebo	10	145

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
19720922	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
G-CSF Plus Plerixafor vs G-CSF Plus Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00103610

GET https://conductscience.org/api/trials/v1/NCT00103610/results?page=2

API reference For AI assistants