Current protocols use G-CSF to mobilize hematopoietic progenitor cells from matched sibling
and volunteer unrelated donors. Unfortunately, this process requires four to six days of
G-CSF injection and can be associated with side effects, most notably bone pain and rarely
splenic rupture. BL-8040 is given as a single SC injection, and collection of cells occurs on
the same day as BL-8040 administration. This study will evaluate the safety and efficacy of
this novel agent for hematopoietic progenitor cell mobilization and allogeneic
transplantation based on the following hypotheses:
- Healthy HLA-matched donors receiving one injection of BL-8040 will mobilize sufficient
CD34+ cells (at least 2.0 x 10^6 CD34+ cells/kg recipient weight) following no more than
two leukapheresis collections to support a hematopoietic cell transplant.
- The hematopoietic cells mobilized by SC BL-8040 will be functional and will result in
prompt and durable hematopoietic engraftment following transplantation into
HLA-identical siblings with advanced hematological malignancies using various
non-myeloablative and myeloablative conditioning regimens and regimens for routine GVHD
- If these hypotheses 1 and 2 are confirmed after an interim safety analysis of the data,
then the study will continue and include recruitment of haploidentical donors.