Ex vivo expanded human myeloid progenitor cells (hMPCs; CLT-008) have the potential to accelerate neutrophil recovery and decrease the risk of febrile neutropenia and infection in patients receiving chemotherapy for acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), chronic myeloid leukemia (CML), or high-risk myelodysplasia (MDS). In this study, the safety, tolerability and activity of CLT-008 administered after "standard of care" cytarabine-based consolidation or induction/re-induction chemotherapy will be determined by monitoring for adverse reactions, infusion reactions, graft-versus host disease (GVHD), neutrophil and platelet recovery, hMPC persistence, infections and complications.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
45
Single intravenous injection/infusion
Background therapy
Moores UCSD Cancer Center
La Jolla, California, United States
University of California San Francisco Medical Center
San Francisco, California, United States
Stanford Hospital and Clinics
Stanford, California, United States
Loyola University Medical Center, Cardinal Bernardin Cancer Center
Maywood, Illinois, United States
Indiana Blood and Marrow Transplantation, LLC
Beech Grove, Indiana, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Incidence of serious adverse reactions
Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Duration of neutropenia
Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Duration of thrombocytopenia
Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Duration of presence of CLT-008 derived cells in blood
Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Duration of presence of CLT-008 derived cells in bone marrow
Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Incidence of mucositis
Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Incidence of infections
Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Duration of fever
Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Duration of antibiotic use
Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Incidence of hospitalization
Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Duration of hospitalization
Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.