Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Chemotherapy for Leukemia

• Duration of neutropenia [ Time Frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose ] [ Designated as safety issue: No ]
• Duration of thrombocytopenia [ Time Frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose ] [ Designated as safety issue: No ]
• 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 ] [ Designated as safety issue: No ]
• 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 ] [ Designated as safety issue: No ]
• Incidence of mucositis [ Time Frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose ] [ Designated as safety issue: No ]
• Incidence of infections [ Time Frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose ] [ Designated as safety issue: No ]
• Duration of fever [ Time Frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose ] [ Designated as safety issue: No ]
• Duration of antibiotic use [ Time Frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose ] [ Designated as safety issue: No ]
• Incidence of hospitalization [ Time Frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose ] [ Designated as safety issue: No ]
• Duration of hospitalization [ Time Frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose ] [ Designated as safety issue: No ]

• Duration of neutropenia [ Time Frame: 43 days post dose ] [ Designated as safety issue: No ]
• Duration of thrombocytopenia [ Time Frame: 43 days post dose ] [ Designated as safety issue: No ]
• Duration of presence of CLT-008 derived cells in blood [ Time Frame: 43 days post dose ] [ Designated as safety issue: No ]
• Duration of presence of CLT-008 derived cells in bone marrow [ Time Frame: 43 days post dose ] [ Designated as safety issue: No ]
• Incidence of mucositis [ Time Frame: 43 days post dose ] [ Designated as safety issue: No ]
• Incidence of infections [ Time Frame: 43 days post dose ] [ Designated as safety issue: No ]
• Duration of fever [ Time Frame: 43 days post dose ] [ Designated as safety issue: No ]
• Duration of antibiotic use [ Time Frame: 43 days post dose ] [ Designated as safety issue: No ]
• Incidence of hospitalization [ Time Frame: 43 days post dose ] [ Designated as safety issue: No ]
• Duration of hospitalization [ Time Frame: 43 days post dose ] [ Designated as safety issue: No ]

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.

• Acute Myeloid Leukemia
• Acute Lymphoblastic Leukemia
• Chronic Myeloid Leukemia
• Myelodysplasia

• Biological: human myeloid progenitor cells
  Single intravenous injection/infusion
  Other Names:

  • CLT-008
  • hMPC
• Drug: G-CSF
  Background therapy
  Other Names:

  • filgrastim
  • granulocyte colony stimulating factor

• Experimental: Consolidation Group A
  Low dose CLT-008 (human myeloid progenitor cells)
  Interventions:

  • Biological: human myeloid progenitor cells
  • Drug: G-CSF
• Experimental: Consolidation Group B
  Intermediate dose CLT-008 (human myeloid progenitor cells)
  Interventions:

  • Biological: human myeloid progenitor cells
  • Drug: G-CSF
• Experimental: Consolidation Group C
  Intermediate dose CLT-008 (human myeloid progenitor cells), no G-CSF
  Intervention: Biological: human myeloid progenitor cells
• Experimental: Consolidation Group D
  High dose CLT-008 (human myeloid progenitor cells)
  Interventions:

  • Biological: human myeloid progenitor cells
  • Drug: G-CSF
• Active Comparator: Induction Group A1 (cytarabine 7+3)
  G-CSF
  Intervention: Drug: G-CSF
• Experimental: Induction Group A2 (cytarabine 7+3)
  Intermediate dose CLT-008 (human myeloid progenitor cells)
  Interventions:

  • Biological: human myeloid progenitor cells
  • Drug: G-CSF
• Experimental: Induction Group A3 (cytarabine 7+3)
  High dose CLT-008 (human myeloid progenitor cells)
  Interventions:

  • Biological: human myeloid progenitor cells
  • Drug: G-CSF
• Active Comparator: Induction Group B1 (cytarabine HIDAC)
  G-CSF
  Intervention: Drug: G-CSF
• Experimental: Induction Group B2 (cytarabine HIDAC)
  Intermediate dose CLT-008 (human myeloid progenitor cells)
  Interventions:

  • Biological: human myeloid progenitor cells
  • Drug: G-CSF
• Experimental: Induction Group B3 (cytarabine HIDAC)
  High dose CLT-008 (human myeloid progenitor cells)
  Interventions:

  • Biological: human myeloid progenitor cells
  • Drug: G-CSF

Key Inclusion Criteria:

• Hematological malignancy, including:

  • AML, ALL or MDS
• Planned treatment with cytarabine-based chemotherapy regimen
• Adequate hepatic, renal, hematologic, cardiac and respiratory function

Key Exclusion Criteria:

• Prior allograft or history of active GVHD within 3 years
• Pregnant or nursing