Trial Outcomes & Findings for Plerixafor for Stem Cell Mobilization in Normal Donors (NCT NCT01818284)

Last Updated: 2019-04-23

Results Overview

Primary safety endpoint is the development of any unexpected toxicity (any grade 2 or higher non-hematologic toxicity) in donors. The severity of the toxicity - adverse events (AEs) graded according to Common Terminology Criteria v4.0 (CTCAE).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

5 days

Results posted on

2019-04-23

Participant Flow

Recruitment Period: October 16, 2013 to May 1, 2015. All recruitment done at The University of Texas MD Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	Filgrastim + Plerixafor for Donors Filgrastim 5 µg/kg subcutaneously daily for 4 days until end of apheresis; Plerixafor 240 µg/kg subcutaneously on fourth day of Filgrastim mobilization; followed by Apheresis day 5 which may continue beyond day 1 until target dose of 4x10\^6 CD34+ cells/kg (recipient's weight) obtained.	Recipients Recipients received Plerixafor mobilized cells for allogeneic hematopoietic stem cell transplantation (HSCT) on day 0 of their designated treatment plan (following day 5 of donor's Plerixafor study specific treatment plan).
Overall Study STARTED	11	11
Overall Study COMPLETED	7	5
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Filgrastim + Plerixafor for Donors Filgrastim 5 µg/kg subcutaneously daily for 4 days until end of apheresis; Plerixafor 240 µg/kg subcutaneously on fourth day of Filgrastim mobilization; followed by Apheresis day 5 which may continue beyond day 1 until target dose of 4x10\^6 CD34+ cells/kg (recipient's weight) obtained.	Recipients Recipients received Plerixafor mobilized cells for allogeneic hematopoietic stem cell transplantation (HSCT) on day 0 of their designated treatment plan (following day 5 of donor's Plerixafor study specific treatment plan).
Overall Study Not eligible due to White Blood Counts	4	4
Overall Study Death	0	2

Baseline Characteristics

Plerixafor for Stem Cell Mobilization in Normal Donors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Donors Filgrastim + Plerixafor n=11 Participants Filgrastim 5 µg/kg subcutaneously daily for 4 days until end of apheresis; Plerixafor 240 µg/kg subcutaneously on fourth day of Filgrastim mobilization; followed by Apheresis day 5 which may continue beyond day 1 until target dose of 4x10\^6 CD34+ cells/kg (recipient's weight) obtained.	Recipients n=11 Participants Recipients received Plerixafor mobilized cells on day 0 of their designated treatment plan (following day 5 of donor's Plerixafor study specific treatment plan).	Total n=22 Participants Total of all reporting groups
Age, Continuous	58 years n=5 Participants	58 years n=7 Participants	58 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 days

Outcome measures

Outcome measures
Measure	Donors: Filgrastim + Plerixafor n=11 Participants Filgrastim 5 µg/kg subcutaneously daily for 4 days until end of apheresis; Plerixafor 240 µg/kg subcutaneously on fourth day of Filgrastim mobilization; followed by Apheresis day 5 which may continue beyond day 1 until target dose obtained.
Summary of Most Common Toxicity: Donor Safety in Mobilizing Peripheral Blood Progenitor Cells (PBPC) Tachycardia	1 adverse events
Summary of Most Common Toxicity: Donor Safety in Mobilizing Peripheral Blood Progenitor Cells (PBPC) Nausea	2 adverse events
Summary of Most Common Toxicity: Donor Safety in Mobilizing Peripheral Blood Progenitor Cells (PBPC) Insomnia	2 adverse events
Summary of Most Common Toxicity: Donor Safety in Mobilizing Peripheral Blood Progenitor Cells (PBPC) Bone pain	2 adverse events
Summary of Most Common Toxicity: Donor Safety in Mobilizing Peripheral Blood Progenitor Cells (PBPC) Injection site reaction	1 adverse events
Summary of Most Common Toxicity: Donor Safety in Mobilizing Peripheral Blood Progenitor Cells (PBPC) Diarrhea	1 adverse events
Summary of Most Common Toxicity: Donor Safety in Mobilizing Peripheral Blood Progenitor Cells (PBPC) Chest Pain	1 adverse events

PRIMARY outcome

Timeframe: 4 days

Population: Four participants did not receive Plerixafor due to a white blood cell count outside of the protocol specific window. It should be noted, the protocol threshold for white blood cell count was amended from 40,000 to 45,000.

Study determined to be feasible if all donors were able to receive Plerixafor without developing any grade 2 or higher non-hematologic toxicity. Feasibility of the combination of Filgrastim, Granulocyte-colony stimulating factor (G-CSF) plus Plerixafor is to effectively mobilize CD34+ cells so that an adequate transplant (\>4 x 10\^6 CD34+ cells/kg) can be reliably collected with one apheresis for allogeneic HSCT.

Outcome measures

Outcome measures
Measure	Donors: Filgrastim + Plerixafor n=7 Participants Filgrastim 5 µg/kg subcutaneously daily for 4 days until end of apheresis; Plerixafor 240 µg/kg subcutaneously on fourth day of Filgrastim mobilization; followed by Apheresis day 5 which may continue beyond day 1 until target dose obtained.
Feasibility in Mobilizing PBPC in Donors: Number of Donors Reaching Stem Cell Target Collection on First Day of Collection Following Treatment of Filgrastim Plus Plerixafor	7 Participants

Adverse Events

Donors Filgrastim + Plerixafor

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Recipients

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Chitra Hosing, MD/Professor, Stem Cell Transplantation

UT MD Anderson Cancer Center

Phone: 713-792-7734

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Donors Filgrastim + Plerixafor n=11 participants at risk Filgrastim 5 µg/kg subcutaneously daily for 4 days until end of apheresis; Plerixafor 240 µg/kg subcutaneously on fourth day of Filgrastim mobilization; followed by Apheresis day 5 which may continue beyond day 1 until target dose of 4x106 CD34+ cells/kg (recipient's weight) obtained.	Recipients n=11 participants at risk Recipients received Plerixafor mobilized cells on day 0 of their designated treatment plan (following day 5 of donor's Plerixafor study specific treatment plan).
Investigations Alanine aminotransferase increased	0.00% 0/11 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	18.2% 2/11 • Number of events 2 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
Blood and lymphatic system disorders Anemia	9.1% 1/11 • Number of events 1 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	0.00% 0/11 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
Investigations Blood bilirubin increased	0.00% 0/11 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	9.1% 1/11 • Number of events 1 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
Musculoskeletal and connective tissue disorders Bone pain	18.2% 2/11 • Number of events 2 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	0.00% 0/11 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
Cardiac disorders Mild tachicardia	9.1% 1/11 • Number of events 1 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	9.1% 1/11 • Number of events 1 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
Cardiac disorders Chest pain - cardiac	9.1% 1/11 • Number of events 1 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	0.00% 0/11 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
Investigations Creatinine increased	0.00% 0/11 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	18.2% 2/11 • Number of events 2 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
Renal and urinary disorders Cystitis noninfective	0.00% 0/11 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	9.1% 1/11 • Number of events 1 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
Gastrointestinal disorders Diarrhea	9.1% 1/11 • Number of events 1 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	27.3% 3/11 • Number of events 3 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
Eye disorders Dry eye	0.00% 0/11 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	9.1% 1/11 • Number of events 1 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
General disorders Fever	0.00% 0/11 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	9.1% 1/11 • Number of events 1 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
General disorders Flu like symptoms	0.00% 0/11 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	27.3% 3/11 • Number of events 3 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
General disorders Nightsweats	9.1% 1/11 • Number of events 1 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	0.00% 0/11 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
Nervous system disorders Headache	9.1% 1/11 • Number of events 1 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	0.00% 0/11 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
Hepatobiliary disorders Elevated bilirubin	0.00% 0/11 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	18.2% 2/11 • Number of events 2 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
Metabolism and nutrition disorders Hyperglycemia	9.1% 1/11 • Number of events 1 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	0.00% 0/11 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
Vascular disorders Hypertension	0.00% 0/11 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	18.2% 2/11 • Number of events 2 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
Metabolism and nutrition disorders Hypomagnesemia	9.1% 1/11 • Number of events 1 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	0.00% 0/11 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
Immune system disorders Neutropenic fever	0.00% 0/11 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	18.2% 2/11 • Number of events 2 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
Infections and infestations CMV Reactivation, Alpha-hemalytic streptococcus bacteremia	0.00% 0/11 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	18.2% 2/11 • Number of events 2 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
Surgical and medical procedures Injection site reaction	9.1% 1/11 • Number of events 1 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	0.00% 0/11 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
Psychiatric disorders Insomnia	18.2% 2/11 • Number of events 2 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	18.2% 2/11 • Number of events 2 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
Gastrointestinal disorders Mucositis oral	0.00% 0/11 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	45.5% 5/11 • Number of events 5 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
Gastrointestinal disorders Nausea	18.2% 2/11 • Number of events 2 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	63.6% 7/11 • Number of events 7 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
Nervous system disorders Altered mental status related to pain medication	0.00% 0/11 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	9.1% 1/11 • Number of events 1 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
General disorders Pain	18.2% 2/11 • Number of events 2 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	27.3% 3/11 • Number of events 3 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/11 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	9.1% 1/11 • Number of events 1 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/11 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	27.3% 3/11 • Number of events 3 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
Renal and urinary disorders Fluid Overload	0.00% 0/11 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	9.1% 1/11 • Number of events 1 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
Skin and subcutaneous tissue disorders Hand & foot syndrome	0.00% 0/11 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	18.2% 2/11 • Number of events 2 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
Vascular disorders Catheter related deep vein thrombosis (DTV)	0.00% 0/11 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	9.1% 1/11 • Number of events 1 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.
Investigations Weight gain	0.00% 0/11 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.	9.1% 1/11 • Number of events 1 • Adverse event data collected for donors over one month period after first injection of filgrastim and for recipients from start of preparative regimen followed by infusion of allogeneic stem cell transplantation Day 0 to Day +30, up to 40 days. For the purpose of this study the treatment plan (preparative regimen followed by infusion of allogeneic stem cell transplantation) is defined as "transplant package"; therefore adverse events known to be caused by components of the transplant package and its direct consequences were collected.