Ignite Creation Date:
2024-05-06 @ 7:58 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02639559
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2015-12-17
Brief Title:
Safety and Efficacy of BL-8040 for the Mobilization of Donor Hematopoietic Stem Cells and Allogeneic Transplantation in Patients With Advanced Hematological Malignancies
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
A Phase II Study Evaluating the Safety and Efficacy of BL-8040 for the Mobilization of Donor Hematopoietic Stem Cells and Allogeneic Transplantation in Patients With Advanced Hematological Malignancies
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 20 x 106 CD34 cellskg 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 prophylaxis
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
Healthy HLA-matched donors receiving one injection of BL-8040 will mobilize sufficient CD34 cells at least 20 x 106 CD34 cellskg 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 prophylaxis
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None