Loyola University Medical Center

Gottlieb Memorial Hospital

MacNeal Hospital

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NCT01297543

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

Official Title:

A Phase I/II Trial of CLT-008 Myeloid Progenitor Cells in Patients Receiving Chemotherapy for Leukemia or Myelodysplasia

Summary

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.

Eligibility

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

Disease(s) and\or Condition(s)

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Chronic Myeloid Leukemia

Myelodysplasia

Primary Purpose
  • SUPPORTIVE_CARE
Intervention/Treatment
    • Type: BIOLOGICAL
    • Name: human myeloid progenitor cells
    • Description: Single intravenous injection/infusion
    • Arm Group Labels: Consolidation Group A, Consolidation Group B, Consolidation Group C, Consolidation Group D, Induction Group A2 (cytarabine 7+3), Induction Group A3 (cytarabine 7+3), Induction Group B2 (cytarabine HIDAC), Induction Group B3 (cytarabine HIDAC)
    • Type: DRUG
    • Name: G-CSF
    • Description: Background therapy
    • Arm Group Labels: Consolidation Group A, Consolidation Group B, Consolidation Group D, Induction Group A1 (cytarabine 7+3), Induction Group A2 (cytarabine 7+3), Induction Group A3 (cytarabine 7+3), Induction Group B1 (cytarabine HIDAC), Induction Group B2 (cytarabine HIDAC), Induction Group B3 (cytarabine HIDAC)
Sponsor
  • Cellerant Therapeutics