Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Syndrome

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Hematologic Neoplasms

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Bone Marrow Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Lymphosarcoma

Anti-Infective Agents

All Drugs and Chemicals

Plerixafor

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

MGTA-145 in combination with plerixafor followed by apheresis on one or two consecutive days

MGTA-145 will be be administered as an IV infusion

MGTA-145

Steven Devine, MD

This research study tests a new medicine for mobilizing stem cells so they can be collected and used for allogeneic stem cell transplant for treatment of hematological malignancies. MGTA-145, the new medicine, will be given with plerixafor.

This is a Phase II, open-label, multicenter, prospective study of MGTA-145 + plerixafor mobilized HLA-matched sibling and matched unrelated donor allografts for myeloablative hematopoietic stem cell transplantation (HSCT) in recipients with hematological malignancies. Donors will undergo 1 or 2 days of mobilization and apheresis.

MGTA-145 + Plerixafor in the Mobilization of HSCs for Allogeneic Transplant in Hematologic Malignancies

A Phase II Study Evaluating the Safety and Efficacy of MGTA-145 in Combination With Plerixafor for the Mobilization and Transplantation of HLA-Matched Donor Hematopoietic Stem Cells in Recipients With Hematological Malignancies

To assess the efficacy of MGTA-145 in combination with plerixafor in mobilizing adequate number of hematopoietic stem cells (≥ 2.0 x 10\^6 CD34+ cells/kg) in healthy donors in one apheresis setting.

To determine the proportion of donors whose cells can be successfully mobilized and collected with a target CD34+ cell dose of at least 4.0 x 10\^6 CD34+ cells/kg actual recipient weight in one apheresis collection

To ascertain the incidence of adverse events (AEs) before and during apheresis experienced by donors receiving MGTA-145 + plerixafor

To ascertain the severity of adverse events (AEs) before and during apheresis experienced by donors receiving MGTA-145 + plerixafor

To determine the incidence of and kinetics of neutrophil and platelet recovery after transplantation of hematopoietic cells mobilized with MGTA-145 + plerixafor

The proportion of participants with primary and secondary graft failure after transplantation of hematopoietic cells mobilized with MGTA-145 + plerixafor

To determine the incidence and severity of acute and chronic graft versus host disease (GVHD) after transplantation of hematopoietic cells mobilized with MGTA-145 + plerixafor

To determine the proportion of treatment-related mortality and disease relapse/progression after transplantation of hematopoietic cells mobilized with MGTA-145 + plerixafor

To determine the probability of progression-free survival after transplantation of hematopoietic cells mobilized with MGTA-145 + plerixafor

To determine the probability of overall survival after transplantation of hematopoietic cells mobilized with MGTA-145 + plerixafor

To characterize the adverse effects experienced by recipients receiving grafts mobilized by MGTA-145 + plerixafor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
MGTA-145 + Plerixafor in the Mobilization of HSCs for Allogeneic Transplant in Hematologic Malignancies	NCT04762875	Related Donors ... Healthy Donors Acute Myelogeno... Acute Lymphobla... Myelodysplastic...	MGTA-145 Plerixafor	18 Years - 65 Years	Ensoma
MGTA-145 + Plerixafor in the Mobilization of HSCs for Allogeneic Transplant in Hematologic Malignancies	NCT04762875	Related Donors ... Healthy Donors Acute Myelogeno... Acute Lymphobla... Myelodysplastic...	MGTA-145 Plerixafor	18 Years - 65 Years	Ensoma

Spots Global Cancer Trial Database for related donors donating pbsc to a family member