Spots Global Cancer Trial Database for NLA101 in Adults Receiving High Dose Chemotherapy for AML
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Trial Identification
Brief Title: NLA101 in Adults Receiving High Dose Chemotherapy for AML
Official Title: A Phase 2 Open-Label, Multi-Center, Randomized, Controlled, Dose-Finding Study of NLA101 in Adults Receiving High Dose Chemotherapy for Acute Myeloid Leukemia
Study ID: NCT03301597
Conditions
Study Description
Brief Summary: Phase 2 open-label, multi-center, randomized, controlled, dose-finding study of safety and efficacy of NLA101 to reduce the rate of infections associated with CIN in adult subjects with AML.
Detailed Description: Phase 2 open-label, multi-center, randomized, controlled, dose-finding study of safety and efficacy of NLA101 to reduce the rate of infections associated with chemotherapy induced neutropenia (CIN) in adult subjects with AML. Eligible subjects with untreated de novo or secondary AML and per local institutional standards planned to receive at least two cycles of chemotherapy with curative intent will be enrolled into the study and randomized 1:1:1:1 to 1 of 3 Investigational Arms (Standard of Care \[SOC\] chemotherapy + low, medium, or high dose NLA101) or a Control Arm (SOC chemotherapy). Subjects randomized to an Investigational Arm will be eligible to receive a single fixed assigned dose of NLA101 after the first cycle of chemotherapy, and up to 2 additional identical cell doses after subsequent chemotherapy cycles (one NLA101 infusion per cycle). Subjects randomized to the Control Arm will be followed for up to 3 cycles of chemotherapy. All subjects will be followed for 84 days following randomization, or 30 days post final infusion of NLA101, or 30 days post the day after the last chemotherapy infusion for Control Arm, whichever is longer.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UC San Diego Moores Cancer Center, La Jolla, California, United States
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
Mayo Clinic Florida, Jacksonville, Florida, United States
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
Norton Cancer Institute, St. Matthews Campus, Louisville, Kentucky, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
University of Nebraska Medical Center - Fred & Pamela Buffett Cancer Center, Omaha, Nebraska, United States
Westchester Medical Center, Hawthorne, New York, United States
Weill Cornell Medical College - NewYork-Presbyterian Hospital, New York, New York, United States
Icahn School of Medicine at Mount Sinai and Mount Sinai Health System, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Stony Brook University, Stony Brook, New York, United States
Duke University Heath System, Duke Cancer Center, Durham, North Carolina, United States
Wake Forest Baptist Health, Winston-Salem, North Carolina, United States
Geisinger Medical Center, Danville, 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
Seattle Cancer Care Alliance, Seattle, Washington, United States
University of Wisconsin, Madison, Wisconsin, United States
Froedtert Hospital and The Medical College of Wisconsin, Milwaukee, Wisconsin, United States
St. Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia
St. George Hospital, Kogarah, New South Wales, Australia
Calvary Mater Newcastle, Waratah, New South Wales, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Austin Health, Heidelberg, Victoria, Australia
Epworth HealthCare, Richmond, Victoria, Australia
Royal Perth Hospital, Perth, Western Australia, Australia
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea's Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Contact Details
Name: Martin S Tallman, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: STUDY_CHAIR
Name: Naval G Daver, MD
Affiliation: M.D. Anderson Cancer Center
Role: STUDY_CHAIR
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