Trial Outcomes & Findings for Plerixafor and Filgrastim For Mobilization of Donor Peripheral Blood Stem Cells Before A Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies (NCT NCT01076270)
NCT ID: NCT01076270
Last Updated: 2017-06-28
Results Overview
Percentage of donors from whom at least 2 x 10\^6 CD34+ cells/kg body weight were collected based on actual recipient body weight
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
1 participants
Primary outcome timeframe
At the end of apheresis for cell collection
Results posted on
2017-06-28
Participant Flow
Participant milestones
| Measure |
Filgrastim and Plerixafor for PBSC Mobilization
Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.
After completion of study treatment, donors are followed up 1 day after the last stem cell donation.
plerixafor: Given SC
filgrastim: Given SC
peripheral blood stem cell transplantation: Infusion of peripheral blood stem cells
allogeneic hematopoietic stem cell transplantation: Infusion of hematopoietic stem cells
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Plerixafor and Filgrastim For Mobilization of Donor Peripheral Blood Stem Cells Before A Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
Baseline characteristics by cohort
| Measure |
Filgrastim and Plerixafor for PBSC Mobilization
n=1 Participants
Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.
After completion of study treatment, donors are followed up 1 day after the last stem cell donation.
plerixafor: Given SC
filgrastim: Given SC
peripheral blood stem cell transplantation: Infusion of peripheral blood stem cells
allogeneic hematopoietic stem cell transplantation: Infusion of hematopoietic stem cells
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At the end of apheresis for cell collectionPopulation: Study terminated early. Results are for the one donor enrolled.
Percentage of donors from whom at least 2 x 10\^6 CD34+ cells/kg body weight were collected based on actual recipient body weight
Outcome measures
| Measure |
Filgrastim and Plerixafor for PBSC Mobilization
n=1 Participants
Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.
After completion of study treatment, donors are followed up 1 day after the last stem cell donation.
plerixafor: Given SC
filgrastim: Given SC
peripheral blood stem cell transplantation: Infusion of peripheral blood stem cells
allogeneic hematopoietic stem cell transplantation: Infusion of hematopoietic stem cells
|
|---|---|
|
Successful Collection of Stem Cells
|
1 Participants
|
SECONDARY outcome
Timeframe: At the end of apheresis for cell collectionPopulation: Trial terminated; only one patient enrolled
Number of CD34-positive cells collected per kg recipient body weight
Outcome measures
| Measure |
Filgrastim and Plerixafor for PBSC Mobilization
n=1 Participants
Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.
After completion of study treatment, donors are followed up 1 day after the last stem cell donation.
plerixafor: Given SC
filgrastim: Given SC
peripheral blood stem cell transplantation: Infusion of peripheral blood stem cells
allogeneic hematopoietic stem cell transplantation: Infusion of hematopoietic stem cells
|
|---|---|
|
CD34-positive Cells Collected
|
4,760,000 CD34-positive cells collected/kg
|
Adverse Events
Filgrastim and Plerixafor for PBSC Mobilization
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Filgrastim and Plerixafor for PBSC Mobilization
n=1 participants at risk
Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.
After completion of study treatment, donors are followed up 1 day after the last stem cell donation.
plerixafor: Given SC
filgrastim: Given SC
peripheral blood stem cell transplantation: Infusion of peripheral blood stem cells
allogeneic hematopoietic stem cell transplantation: Infusion of hematopoietic stem cells
|
|---|---|
|
General disorders
Lightheadedness
|
100.0%
1/1 • Number of events 1 • From the first dose of study drug to one week after the last clinic visit. The last clinic visit typically occurs the day after stem cell collection is completed.
|
|
Gastrointestinal disorders
Flatulence
|
100.0%
1/1 • Number of events 1 • From the first dose of study drug to one week after the last clinic visit. The last clinic visit typically occurs the day after stem cell collection is completed.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
1/1 • Number of events 1 • From the first dose of study drug to one week after the last clinic visit. The last clinic visit typically occurs the day after stem cell collection is completed.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
100.0%
1/1 • Number of events 1 • From the first dose of study drug to one week after the last clinic visit. The last clinic visit typically occurs the day after stem cell collection is completed.
|
|
General disorders
Headache
|
100.0%
1/1 • Number of events 1 • From the first dose of study drug to one week after the last clinic visit. The last clinic visit typically occurs the day after stem cell collection is completed.
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1 • From the first dose of study drug to one week after the last clinic visit. The last clinic visit typically occurs the day after stem cell collection is completed.
|
Additional Information
Dr. William Bensinger
Fred Hutchinson Cancer Research Center
Phone: 206-667-4730
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60