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Safety and Efficacy of BL-8040 for the Mobilization of Donor Hematopoietic Stem Cells and Allogeneic Transplantation in Patients With Advanced Hematological Malignancies

Multiple Myeloma Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Acute Lymphoblastic Leukemia
  • Acute Myelogenous Leukemia
  • Chronic Myelogenous Leukemia
  • Hematologic Neoplasms
  • Hodgkin Disease
  • Hodgkin's Disease
  • Hodgkins Disease
  • Leukemia
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Acute
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Myelodysplastic Syndrome
  • Myelodysplastic Syndromes
  • Myeloproliferative Disorders
  • Myeloproliferative Neoplasm
  • Non-Hodgkin Lymphoma
  • Non-Hodgkin's Lymphoma
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
Clinical Trial Details
NCT number NCT02639559
Study type Interventional
Source Washington University School of Medicine
Contact
Status Completed
Phase Phase 2
Start date March 31, 2016
Completion date April 7, 2023
View Details
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