Phase 2 N=22 Treatment

Plerixafor for Stem Cell Mobilization in Normal Donors

Blood And Marrow Transplantation

Bottom Line

View on ClinicalTrials.gov: NCT01818284 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2019

Primary outcome: Primary: Summary of Most Common Toxicity: Donor Safety in Mobilizing Peripheral Blood Progenitor Cells (PBPC) — 1; 2; 2; 2 adverse events

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Filgrastim (Drug); Plerixafor (Drug); Apheresis Procedure (Procedure)
Age: Pediatric, Adult, Older Adult · 10+ yrs
Sex: All
Sponsor: M.D. Anderson Cancer Center
Primary completion: Jun 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Summary of Most Common Toxicity: Donor Safety in Mobilizing Peripheral Blood Progenitor Cells (PBPC)	1; 2; 2; 2; 1; 1	—
PRIMARY 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	—

Summary

The goal of this clinical research study is to learn if treating stem cell donors with filgrastim (G-CSF) and plerixafor (Mozobil®) can cause them to produce a higher number of blood stem cells than filgrastim by itself. Researchers also want to learn if giving both of these drugs helps donors produce enough stem cells so that only 1 apheresis procedure needs to be performed. Researchers will study if using both drugs lowers the risk of the stem cell transplant recipients developing severe forms graft-versus-host disease (GVHD). GVHD is a condition in which transplanted tissue (such as blood stem cells) attacks the tissue of the recipient's body. The safety and effectiveness of this drug combination will also be studied. Filgrastim and plerixafor are both designed to help move or "mobilize" the stem cells from the bone marrow to the blood.

Eligibility Criteria

Inclusion Criteria

Donor eligibility: Age >/= 10 years.
Donor eligibility: Related donors who met standard eligibility criteria and are willing to participate in this study.
Donor eligibility: Able to provide informed consent.
Recipient Eligibility: Patients who are scheduled to undergo an allogeneic related transplant and whose donors consented to participate in this study.
Recipient Eligibility: Able to provide informed consent.

Exclusion Criteria

Donors who are on anti-coagulation or anti-platelet agents are not eligible.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01818284). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.