Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Chemotherapy for Leukemia
Completed · Phase 1/Phase 2
Conditions studied: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia, Myelodysplasia
In brief
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.
Key facts
- Study ID
- NCT01297543
- Run by
- Cellerant Therapeutics
- People needed
- 45
- Starts
- 2011-03-01
- Expected to finish
- 2015-01-01
- Last updated by the study team
- 2016-07-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Moores UCSD Cancer Center — La Jolla, California, United States
- University of California San Francisco Medical Center — San Francisco, California, United States
- Stanford Hospital and Clinics — Stanford, California, United States
- Loyola University Medical Center, Cardinal Bernardin Cancer Center — Maywood, Illinois, United States
- Indiana Blood and Marrow Transplantation, LLC — Beech Grove, Indiana, United States
- University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
- University of Minnesota — Minneapolis, Minnesota, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- The Western Pennsylvania Hospital — Pittsburgh, Pennsylvania, United States
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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