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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Cellerant Therapeutics
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Cellerant Therapeutics
ClinicalTrials.gov Identifier:
NCT01297543
First received: February 11, 2011
Last updated: August 6, 2013
Last verified: August 2013

February 11, 2011
August 6, 2013
March 2011
March 2014   (final data collection date for primary outcome measure)
Incidence of serious adverse reactions [ Time Frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose ] [ Designated as safety issue: Yes ]
Incidence of serious adverse reactions [ Time Frame: 43 days post dose ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01297543 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
 
Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Chemotherapy for Leukemia
A Phase I/II Trial of CLT-008 Myeloid Progenitor Cells in Patients Receiving Chemotherapy for Leukemia or Myelodysplasia

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
82
Not Provided
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Rod Van Syoc 650-232-2124 rvansyoc@cellerant.com
United States
 
NCT01297543
CLT008-02
No
Cellerant Therapeutics
Cellerant Therapeutics
Department of Health and Human Services
Not Provided
Cellerant Therapeutics
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP