Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
Hematological malignancy, including:
Planned treatment with cytarabine-based chemotherapy regimen
Adequate hepatic, renal, hematologic, cardiac and respiratory function
Key Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
45 participants in 10 patient groups
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Data sourced from clinicaltrials.gov
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