Spots Global Cancer Trial Database for Safety and Efficacy of Human Myeloid Progenitor Cells (CLT-008) During Chemotherapy for Acute Myeloid Leukemia
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Trial Identification
Brief Title: Safety and Efficacy of Human Myeloid Progenitor Cells (CLT-008) During Chemotherapy for Acute Myeloid Leukemia
Official Title: An Open-Label Phase 2 Prospective, Randomized, Controlled Study of CLT-008 Myeloid Progenitor Cells as a Supportive Care Measure During Induction Chemotherapy for Acute Myeloid Leukemia
Study ID: NCT02282215
Study Description
Brief Summary: The purpose of the study is to explore the safety and efficacy of CLT-008 as an extra supportive care measure after induction chemotherapy for patients with acute myeloid leukemia (AML).
Detailed Description: The prolonged period of severe neutropenia caused by induction chemotherapy for the treatment of AML is associated with a nearly universal risk of febrile neutropenia. Standard supportive care strategies include administration of prophylactic anti-bacterial and anti-fungal agents, but serious breakthrough bacterial and fungal infections still occur. Granulocyte colony-stimulating factor (G-CSF; filgrastim, Neupogen®) has been shown to shorten the duration of severe neutropenia, fever, antibiotic use and hospitalization following induction chemotherapy for AML. CLT-008, a human allogeneic myeloid progenitor cell product, is intended to provide the cellular target for G-CSF to produce neutrophils during the period of chemotherapy-induced bone marrow suppression when the patient's own progenitor cells may be limited in responding to G-CSF. It is hypothesized that the production of allogeneic neutrophils from CLT-008 will be sufficient to mitigate the infection-related consequences of induction chemotherapy for AML.
Eligibility
Minimum Age: 55 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California San Diego Moores Cancer Center, La Jolla, California, United States
Ronald Reagan UCLA Medical Center, Los Angeles, California, United States
University of California, San Francisco Medical Center, San Francisco, California, United States
UF Health Shands Cancer Hospital, Gainesville, Florida, United States
Mayo Clinic Florida, Jacksonville, Florida, United States
Northside Hospital, Atlanta, Georgia, United States
Northwestern Medical Faculty Foundation, Chicago, Illinois, United States
University of Illinois Cancer Center, Chicago, Illinois, United States
The University of Chicago, Chicago, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
Indiana Blood and Marrow Transplantation Clinic, Indianapolis, Indiana, United States
University of Massachusetts Worcester, Worcester, Massachusetts, United States
University of Minnesota Physicians BMT Clinic, Minneapolis, Minnesota, United States
Kansas City Veterans Affairs Medical Center, Kansas City, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Weill Cornell Medical College - New York Presbyterian Hospital, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Westchester Medical Center, Valhalla, New York, United States
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
West Penn Hospital, Pittsburgh, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Swedish Cancer Institute, Seattle, Washington, United States
Contact Details
Name: William Reed, MD
Affiliation: Cellerant Therapeutics
Role: STUDY_DIRECTOR
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