Trials / Completed
CompletedNCT02639559
Safety and Efficacy of BL-8040 for the Mobilization of Donor Hematopoietic Stem Cells and Allogeneic Transplantation in Patients With Advanced Hematological Malignancies
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Washington University School of Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
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 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 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.
Conditions
- Acute Myelogenous Leukemia
- Acute Lymphoblastic Leukemia
- Chronic Myelogenous Leukemia
- Non-Hodgkin's Lymphoma
- Non-Hodgkin Lymphoma
- Hodgkin Disease
- Hodgkins Disease
- Hodgkin's Disease
- Multiple Myeloma
- Myelodysplastic Syndrome
- Myeloproliferative Neoplasm
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BL-8040 | |
| PROCEDURE | Leukapheresis | |
| PROCEDURE | Hematopoietic cell transplant |
Timeline
- Start date
- 2016-03-31
- Primary completion
- 2018-04-12
- Completion
- 2023-04-07
- First posted
- 2015-12-24
- Last updated
- 2023-11-07
- Results posted
- 2019-05-01
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02639559. Inclusion in this directory is not an endorsement.