Trial Outcomes & Findings for The Effect of Rituximab on Mobilization With AMD3100 (Plerixafor) Plus G-CSF in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL) or Hodgkin Disease (HD) (NCT NCT00444912)

Last Updated: 2014-03-13

Results Overview

Number of participants with adverse events (AEs) collected from Day 1 (start of G-CSF mobilization in participants with CD20- lymphoma or start of rituximab in participants with CD20+ lymphoma) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for seriousness and relatedness to study treatment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Day 1 and up to Day 59 (maximum time before start of chemotherapy)

Results posted on

2014-03-13

Participant Flow

Participant milestones

Participant milestones
Measure	G-CSF and Plerixafor Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor	G-CSF and Plerixafor + Rituximab Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
Overall Study STARTED	15	15
Overall Study Received Plerixafor	15	15
Overall Study Received Transplant	14	14
Overall Study COMPLETED	12	13
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	G-CSF and Plerixafor Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor	G-CSF and Plerixafor + Rituximab Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
Overall Study Death	1	2
Overall Study Lost to Follow-up	1	0
Overall Study Participant Failed Mobilization	1	0

Baseline Characteristics

The Effect of Rituximab on Mobilization With AMD3100 (Plerixafor) Plus G-CSF in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL) or Hodgkin Disease (HD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	G-CSF and Plerixafor n=15 Participants Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor	G-CSF and Plerixafor + Rituximab n=15 Participants Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor	Total n=30 Participants Total of all reporting groups
Age, Continuous	39.3 years STANDARD_DEVIATION 11.3 • n=5 Participants	46.5 years STANDARD_DEVIATION 14.9 • n=7 Participants	42.9 years STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Race/Ethnicity, Customized African-American	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Disease Diagnosis Hodgkin disease (HD)	14 Participants n=5 Participants	4 Participants n=7 Participants	18 Participants n=5 Participants
Disease Diagnosis Non-Hodgkin lymphoma (NHL)	1 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 and up to Day 59 (maximum time before start of chemotherapy)

Population: Safety Population: all participants who received at least 1 dose of study drug (G-CSF, plerixafor, or rituximab)

Outcome measures

Outcome measures
Measure	G-CSF and Plerixafor n=15 Participants Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor	G-CSF and Plerixafor + Rituximab n=15 Participants Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
Summary of Adverse Events (AEs) Participants Reporting at Least 1 AE	9 participants	13 participants
Summary of Adverse Events (AEs) Participant Count of Mild AEs	7 participants	12 participants
Summary of Adverse Events (AEs) Participant Count of Moderate AEs	2 participants	0 participants
Summary of Adverse Events (AEs) Participant Count of Severe AEs	0 participants	0 participants
Summary of Adverse Events (AEs) Participant Count of Life-Threatening AEs	0 participants	1 participants
Summary of Adverse Events (AEs) AEs by Relationship - Not Related	1 participants	0 participants
Summary of Adverse Events (AEs) AEs by Relationship - Probably Not Related	3 participants	4 participants
Summary of Adverse Events (AEs) AEs by Relationship - Possibly Related	0 participants	5 participants
Summary of Adverse Events (AEs) AEs by Relationship - Probably Related	2 participants	3 participants
Summary of Adverse Events (AEs) AEs by Relationship - Definitely Related	3 participants	1 participants

SECONDARY outcome

Timeframe: Days 5-8

Population: Full Analysis Set (FAS) includes all participants who received at least 1 dose of plerixafor.

Median total number of CD34+ cells collected during apheresis.

Outcome measures

Outcome measures
Measure	G-CSF and Plerixafor n=15 Participants Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor	G-CSF and Plerixafor + Rituximab n=15 Participants Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
Median Cumulative Number of CD34+ Cells Collected During Apheresis	7.4 CD34+ cells (*10^6 / kg) Interval 0.9 to 14.1	6.4 CD34+ cells (*10^6 / kg) Interval 2.5 to 10.9

SECONDARY outcome

Timeframe: Days 4-5

Population: Evaluable population of participants with peripheral blood CD34+ measurements on Days 4 and 5.

Fold Increase = (Pre-Apheresis CD34+ cells/Pre-Plerixafor CD34+ cells).

Outcome measures

Outcome measures
Measure	G-CSF and Plerixafor n=6 Participants Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor	G-CSF and Plerixafor + Rituximab n=11 Participants Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
Median Fold Increase in the Number of CD34+ Cells After Plerixafor Administration	2.4 fold increase Interval 1.6 to 1321.3	2.5 fold increase Interval 1.6 to 68.5

SECONDARY outcome

Timeframe: Days 5-8

Population: Evaluable population of participants who achieved ≥3\*10\^cells/kg collected during apheresis.

Median number of apheresis days in each treatment arm to collect a minimum of 3\*10\^6 CD34+ cells/kg.

Outcome measures

Outcome measures
Measure	G-CSF and Plerixafor n=14 Participants Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor	G-CSF and Plerixafor + Rituximab n=14 Participants Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
Median Number of Apheresis Days Required to Reach a Minimum of 3*10^6 CD34+ Cells/kg	1.0 days Interval 1.0 to 3.0	1.0 days Interval 1.0 to 2.0

SECONDARY outcome

Timeframe: Days 5-8

Population: Evaluable population of participants who achieved ≥5\*10\^cells/kg collected during apheresis.

Median number of apheresis days in each treatment arm to reach the target of 5\*10\^6 CD34+ cells/kg.

Outcome measures

Outcome measures
Measure	G-CSF and Plerixafor n=10 Participants Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor	G-CSF and Plerixafor + Rituximab n=12 Participants Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
Median Number of Apheresis Days Required to Reach the Target of 5*10^6 CD34+ Cells/kg	1.0 days Interval 1.0 to 4.0	2.0 days Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: Days post transplantation (approximately Day 40)

Population: Evaluable population of participants who received a stem cell transplant and had PMN engraftment

Median number of days from transplantation to PMN engraftment which 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.

Outcome measures

Outcome measures
Measure	G-CSF and Plerixafor n=14 Participants Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor	G-CSF and Plerixafor + Rituximab n=14 Participants Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
Median Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment	13.0 days Interval 11.0 to 21.0	13.5 days Interval 11.0 to 16.0

SECONDARY outcome

Timeframe: Days post transplantation (approximately Day 40)

Population: Evaluable population of participants who received a stem cell transplant and had PLT engraftment.

Median number of days from transplantation to PLT engraftment which was defined as platelet counts ≥20\*10\^9/L without transfusion for the preceding 7 days or platelet counts ≥50\*10\^9/L for one day. Time to engraftment corresponded to the first day that the criteria were met.

Outcome measures

Outcome measures
Measure	G-CSF and Plerixafor n=14 Participants Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor	G-CSF and Plerixafor + Rituximab n=13 Participants Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
Median Number of Days to Platelet (PLT) Engraftment	21.0 days Interval 13.0 to 31.0	22.0 days Interval 16.0 to 28.0

SECONDARY outcome

Timeframe: Days post transplantation (approximately Day 40)

Population: Evaluable population of participants who received a stem cell transplant and had lymphocyte engraftment.

Median number of days from transplantation to lymphocyte engraftment which was defined as lymphocyte counts ≥5\*10\^8/L. Time to engraftment corresponded to the first day that criteria were met.

Outcome measures

Outcome measures
Measure	G-CSF and Plerixafor n=14 Participants Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor	G-CSF and Plerixafor + Rituximab n=14 Participants Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
Median Number of Days to Lymphocyte Engraftment	14.5 days Interval 9.0 to 32.0	14.0 days Interval 7.0 to 22.0

SECONDARY outcome

Timeframe: Approximately 7 months (6 months post-transplant)

Population: Evaluable population of participants who received a stem cell transplant and had assessment performed 6 months post-transplant.

Outcome measures

Outcome measures
Measure	G-CSF and Plerixafor n=5 Participants Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor	G-CSF and Plerixafor + Rituximab n=4 Participants Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
Median Level of CD19+CD2-CD14- B-cells Six Months Post-Transplant	155.00 cells / μL Interval 61.0 to 311.0	0.50 cells / μL Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: 13 months (12 months post-transplant)

Population: Evaluable population of participants who received a stem cell transplant and had assessment performed 12 months post-transplant.

Outcome measures

Outcome measures
Measure	G-CSF and Plerixafor n=6 Participants Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor	G-CSF and Plerixafor + Rituximab n=6 Participants Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
Median Level of CD19+CD2-CD14- B-cells Twelve Months Post-Transplant	322.50 cells / μL Interval 189.0 to 518.0	236.00 cells / μL Interval 0.0 to 457.0

SECONDARY outcome

Timeframe: Day 5

Population: Full Analysis Set (FAS) includes all participants who received at least 1 dose of plerixafor.

Outcome measures

Outcome measures
Measure	G-CSF and Plerixafor n=15 Participants Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor	G-CSF and Plerixafor + Rituximab n=15 Participants Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
The Percentage of CD19+CD3-CD14- B-cells of the Total Cells on the First Apheresis Day	2.83 percentage of total cells Interval 0.07 to 7.86	0.09 percentage of total cells Interval 0.01 to 0.39

SECONDARY outcome

Timeframe: Approximately 13 months (12 months post-transplant )

Population: Evaluable population of participants who received a stem cell transplant and had a 12-month assessment.

The number of participants maintaining a durable graft 12 months after autologous transplantation. A durable graft is defined as the maintenance of normal blood counts.

Outcome measures

Outcome measures
Measure	G-CSF and Plerixafor n=14 Participants Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor	G-CSF and Plerixafor + Rituximab n=14 Participants Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
Number of Participants With Durable Engraftment 12 Months After Transplantation	12 participants	13 participants

Adverse Events

G-CSF and Plerixafor

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

G-CSF and Plerixafor + Rituximab

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	G-CSF and Plerixafor n=15 participants at risk Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor	G-CSF and Plerixafor + Rituximab n=15 participants at risk Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
Hepatobiliary disorders Cholelithiasis	0.00% 0/15 • First day of G-CSF mobilization to the day prior to chemotherapy/ablative treatment in preparation for the first transplant. This timeframe includes G-CSF and plerixafor administration (rituximab if applicable), and the rest period. In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.	6.7% 1/15 • First day of G-CSF mobilization to the day prior to chemotherapy/ablative treatment in preparation for the first transplant. This timeframe includes G-CSF and plerixafor administration (rituximab if applicable), and the rest period. In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/15 • First day of G-CSF mobilization to the day prior to chemotherapy/ablative treatment in preparation for the first transplant. This timeframe includes G-CSF and plerixafor administration (rituximab if applicable), and the rest period. In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.	6.7% 1/15 • First day of G-CSF mobilization to the day prior to chemotherapy/ablative treatment in preparation for the first transplant. This timeframe includes G-CSF and plerixafor administration (rituximab if applicable), and the rest period. In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes all events, regardless of reported relationship to study treatment or grade.

Other adverse events

Additional Information

Medical Information

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