Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Chemotherapy for Leukemia
- Conditions
- Acute Myeloid LeukemiaAcute Lymphoblastic LeukemiaChronic Myeloid LeukemiaMyelodysplasia
- Interventions
- Biological: human myeloid progenitor cells
- Registration Number
- NCT01297543
- Lead Sponsor
- Cellerant Therapeutics
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
-
Hematological malignancy, including:
- AML, ALL or MDS
-
Planned treatment with cytarabine-based chemotherapy regimen
-
Adequate hepatic, renal, hematologic, cardiac and respiratory function
Key
- Prior allograft or history of active GVHD within 3 years
- Pregnant or nursing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Consolidation Group D human myeloid progenitor cells High dose CLT-008 (human myeloid progenitor cells) Consolidation Group A human myeloid progenitor cells Low dose CLT-008 (human myeloid progenitor cells) Consolidation Group B human myeloid progenitor cells Intermediate dose CLT-008 (human myeloid progenitor cells) Induction Group A2 (cytarabine 7+3) human myeloid progenitor cells Intermediate dose CLT-008 (human myeloid progenitor cells) Consolidation Group C human myeloid progenitor cells Intermediate dose CLT-008 (human myeloid progenitor cells), no G-CSF Induction Group A3 (cytarabine 7+3) human myeloid progenitor cells High dose CLT-008 (human myeloid progenitor cells) Induction Group B2 (cytarabine HIDAC) human myeloid progenitor cells Intermediate dose CLT-008 (human myeloid progenitor cells) Induction Group B3 (cytarabine HIDAC) human myeloid progenitor cells High dose CLT-008 (human myeloid progenitor cells) Consolidation Group B G-CSF Intermediate dose CLT-008 (human myeloid progenitor cells) Consolidation Group A G-CSF Low dose CLT-008 (human myeloid progenitor cells) Induction Group A1 (cytarabine 7+3) G-CSF G-CSF Consolidation Group D G-CSF High dose CLT-008 (human myeloid progenitor cells) Induction Group A2 (cytarabine 7+3) G-CSF Intermediate dose CLT-008 (human myeloid progenitor cells) Induction Group A3 (cytarabine 7+3) G-CSF High dose CLT-008 (human myeloid progenitor cells) Induction Group B1 (cytarabine HIDAC) G-CSF G-CSF Induction Group B2 (cytarabine HIDAC) G-CSF Intermediate dose CLT-008 (human myeloid progenitor cells) Induction Group B3 (cytarabine HIDAC) G-CSF High dose CLT-008 (human myeloid progenitor cells)
- Primary Outcome Measures
Name Time Method Incidence of serious adverse reactions Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
- Secondary Outcome Measures
Name Time Method Incidence of mucositis Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose Duration of thrombocytopenia Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose Incidence of infections Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose Duration of hospitalization 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 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 Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose Duration of fever Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose Duration of neutropenia Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose Duration of antibiotic use Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose Incidence of hospitalization Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Related Research Topics
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Trial Locations
- Locations (10)
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
The Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Indiana Blood and Marrow Transplantation, LLC
🇺🇸Beech Grove, Indiana, United States
Stanford Hospital and Clinics
🇺🇸Stanford, California, United States
Loyola University Medical Center, Cardinal Bernardin Cancer Center
🇺🇸Maywood, Illinois, United States
University of California San Francisco Medical Center
🇺🇸San Francisco, California, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States