NCT01026987

Granulocyte Colony-stimulating Factor (G-CSF) Plus or Minus AMD3100 for Engraftment Post Allogeneic Transplant

A Pilot Study of G-CSF +/- Plerixafor (AMD3100) Mobilized Donor CD34+ Enriched Peripheral Blood Mononuclear Cells for the Treatment of Allogeneic Stem Cell Transplant Recipients With Limited Donor Engraftment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Patients who have not had adequate blood count recovery post related or unrelated stem cell transplant will be given a "boost" of T-cell depleted, enriched stem cells to hopefully improve their blood counts.

Detailed description

Patients who have not had adequate blood count recovery post related or unrelated stem cell transplant will be given a "boost" of T-cell depleted, enriched stem cells to hopefully improve their blood counts. The unrelated donors will receive G-CSF prior to pheresis (collection of the stem cells) to boost the number of CD34+ cells. The related donors will receive G-CSF and AMD3100 prior to pheresis to boost the number of CD34+ cells. Once the CD34+ cells are collected they will be T-cell depleted using a cell separation device called the CliniMACS systems. The CliniMACS system will select the CD34+ cell and remove the T-cells. By removing the T-cells we can minimize the risk of Graft Versus Host Disease (GVHD). The enriched CD34+ cells will be given to them to hopefully give them a "boost" of cells that can permanently produce new blood cells to improve their risk of infection and bleeding.

Conditions

• Stem Cell Transplant Patients

Interventions

Type	Name	Description
DRUG	G-CSF	Unrelated donors will receive only G-CSF (10 ug/Kg S/C qDay x5-6 days) prior to pheresis (collection of the stem cells). Unrelated donors will only be followed per NMDP guidelines.
DRUG	AMD3100
PROCEDURE	Leukapheresis
PROCEDURE	Stem Cell Infusion

Timeline

• Start date: 2010-04-29
• Primary completion: 2014-04-01
• Completion: 2016-06-08
• First posted: 2009-12-07
• Last updated: 2017-01-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study