Trial Outcomes & Findings for Study of Plerixafor for Rescue of Poor Mobilizers in Autologous Stem Cell Transplant (NCT NCT00901225)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

5 days after receiving G-CSF

Results posted on

2014-05-07

Participant Flow

The first patient was enrolled in April 2005 and the final patient enrolled in August 2010. The protocol was closed to accrual for approximately 3.5yrs, so the total time to protocol activation was 15 months. This was a single institution study (Duke adult stem cell transplant program).

All patients deemed to be poor mobilizers to G-CSF as a single agent, were eligible for enrollment (assuming protocol eligibility criteria were met).

Participant milestones

Participant milestones
Measure	G-CSF Plus Plerixafor Patients who were unable to mobilize a minimum number of cells (CD34+ cell count \<20 cells/ul)following 5 days of G-CSF mobilization.
Overall Study STARTED	21
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Plerixafor for Rescue of Poor Mobilizers in Autologous Stem Cell Transplant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	G-CSF Plus Plerixafor n=21 Participants Patients who were unable to mobilize a minimum number of cells (CD34+ cell count \<20 cells/ul)following 5 days of G-CSF mobilization.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Age, Continuous	61 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 days after receiving G-CSF

Outcome measures

Outcome measures
Measure	G-CSF Plus Plerixafor n=20 Participants Patients who were unable to mobilize a minimum number of cells (CD34+ cell count \<20 cells/ul)following 5 days of G-CSF mobilization.
Number of Participants Who Achieved > or Equal to 2 X 10(6)CD34+ Cells/kg Within 3 Days of Apheresis After Receiving Plerixafor With G-CSF.	15 participants

SECONDARY outcome

Timeframe: 6 months post transplant or until relapse

Safety of plerixafor as measured by Grade III/IV Toxicity

Outcome measures

Outcome measures
Measure	G-CSF Plus Plerixafor n=20 Participants Patients who were unable to mobilize a minimum number of cells (CD34+ cell count \<20 cells/ul)following 5 days of G-CSF mobilization.
Number of Participants Experiencing a Grade III/IV Toxicity	0 participants

SECONDARY outcome

Timeframe: 12 months

To investigate the hematological activity of Plerixafor as measured by Graft Failure. Graft failure is defined as failure of initial engraftment (primary graft failure) or initial engraftment, but subsequent loss of hematopoiesis (secondary graft failure).

Outcome measures

Outcome measures
Measure	G-CSF Plus Plerixafor n=20 Participants Patients who were unable to mobilize a minimum number of cells (CD34+ cell count \<20 cells/ul)following 5 days of G-CSF mobilization.
Number of Subjects Experiencing Graft Failure	0 participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	G-CSF Plus Plerixafor n=20 Participants Patients who were unable to mobilize a minimum number of cells (CD34+ cell count \<20 cells/ul)following 5 days of G-CSF mobilization.
Days to Absolute Neutrophil Count >500	11 days Interval 10.0 to 16.0

SECONDARY outcome

Timeframe: 12 months

Durability of engraftment is defined as the duration and stability of hematopoiesis following autologous transplantation. Subjects who experience durable engraftment have neutrophil counts greater than 500 and platelet counts greater than 20,000 within the specified time frame.

Outcome measures

Outcome measures
Measure	G-CSF Plus Plerixafor n=20 Participants Patients who were unable to mobilize a minimum number of cells (CD34+ cell count \<20 cells/ul)following 5 days of G-CSF mobilization.
Number of Subjects Experiencing Durability of Engraftment	20 participants

SECONDARY outcome

Timeframe: 12 months

Days to platelet count \>20,000

Outcome measures

Outcome measures
Measure	G-CSF Plus Plerixafor n=20 Participants Patients who were unable to mobilize a minimum number of cells (CD34+ cell count \<20 cells/ul)following 5 days of G-CSF mobilization.
Platelet Engraftment	19 days Interval 10.0 to 44.0

Adverse Events

G-CSF Plus Plerixafor

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	G-CSF Plus Plerixafor n=21 participants at risk Patients who were unable to mobilize a minimum number of cells (CD34+ cell count \<20 cells/ul)following 5 days of G-CSF mobilization.
Blood and lymphatic system disorders Febrile neutropenia	19.0% 4/21 • Number of events 6

Additional Information

Mitchell E Horwitz, MD, Principal Investigator

Duke University Medical Center

Phone: 919-668-1045

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place