Open AccessSalvage treatment with plerixafor in poor mobilizing allogeneic stem cell donors: results of a prospective phase II-trial
Author(s) -
Kristina Hölig,
Helmuth Schmidt,
Gero Hütter,
Michael Kramer,
Raphael Teipel,
Katharina Heidrich,
Kristin Zimmer,
Falk Heidenreich,
Matthias Blechschmidt,
Tigran Torosian,
Rainer Ordemann,
Frank Kroschinsky,
Elke RückerBraun,
Laszlo Gopsca,
Eva Wagner-Drouet,
Uta Oelschlaegel,
Alexander H. Schmidt,
Martin Bornhäuser,
Gerhard Ehninger,
Johannes Schetelig
Publication year - 2020
Publication title -
bone marrow transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.609
H-Index - 127
eISSN - 1476-5365
pISSN - 0268-3369
DOI - 10.1038/s41409-020-01053-4
Subject(s) - medicine , plerixafor , apheresis , granulocyte colony stimulating factor , cd34 , adverse effect , surgery , prospective cohort study , stem cell , urology , gastroenterology , chemotherapy , platelet , cxcr4 , chemokine , receptor , biology , genetics
We conducted a prospective clinical trial to investigate the safety and efficacy of plerixafor (P) in allogeneic peripheral blood stem cells (PBSC) donors with poor mobilization response to standard-dose granulocyte colony-stimulating factor (G-CSF), defined by <2 × 10 6 CD34 + cells/kg recipient body-weight (CD34+/kg RBW) after 1st apheresis. A single dose of 240 µg/kg P was injected subcutaneously at 10 p.m. on the day of the 1st apheresis. Thirty-seven allogeneic PBSC donors underwent study treatment. The median CD34+ count in peripheral blood was 15/µl on Day 1 after G-CSF alone, versus 44/µl on Day 2 after G-CSF plus P (p < 0.001). The median yield of CD34+ cells was 1.1 × 10 8 on Day 1 and 2.8 × 10 8 on Day 2. In contrast to a median yield of only 1.31 × 10 6 CD CD34+/kg RBW on Day 1, triggering study inclusion, a median of 3.74 × 10 6 CD CD34+/kg RBW were collected with G-CSF plus P on Day 2. Of 37 donors, 21 reached the target cell count of >4.5 × 10 6 CD34+/kg RBW (57%, 95%CI 40-73%). No donor experienced a severe adverse event requiring treatment. In conclusion, P might be considered on a case-by-case basis for healthy allogeneic donors with very poor stem cell mobilization success after G-CSF.