Spots Global Cancer Trial Database for Tagraxofusp in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies
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Trial Identification
Brief Title: Tagraxofusp in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies
Official Title: A Phase I Study of Tagraxofusp With or Without Chemotherapy in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies
Study ID: NCT05476770
Study Description
Brief Summary: Tagraxofusp is a protein-drug conjugate consisting of a diphtheria toxin redirected to target CD123 has been approved for treatment in pediatric and adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). This trial aims to examine the safety of this novel agent in pediatric patients with relapsed/refractory hematologic malignancies. The mechanism by which tagraxofusp kills cells is distinct from that of conventional chemotherapy. Tagraxofusp directly targets CD123 that is present on tumor cells, but is expressed at lower or levels or absent on normal hematopoietic stem cells. Tagraxofusp also utilizes a payload that is not cell cycle dependent, making it effective against both highly proliferative tumor cells and also quiescent tumor cells. The rationale for clinical development of tagraxofusp for pediatric patients with hematologic malignancies is based on the ubiquitous and high expression of CD123 on many of these diseases, as well as the highly potent preclinical activity and robust clinical responsiveness in adults observed to date. This trial includes two parts: a monotherapy phase and a combination chemotherapy phase. This design will provide further monotherapy safety data and confirm the FDA approved pediatric dose, as well as provide safety data when combined with chemotherapy. The goal of this study is to improve survival rates in children and young adults with relapsed hematological malignancies, determine the recommended phase 2 dose (RP2D) of tagraxofusp given alone and in combination with chemotherapy, as well as to describe the toxicities, pharmacokinetics, and pharmacodynamic properties of tagraxofusp in pediatric patients. About 54 children and young adults will participate in this study. Patients with Down syndrome will be included in part 1 of the study.
Detailed Description:
Keywords
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital Los Angeles, Los Angeles, California, United States
Children's Hospital Orange County, Orange, California, United States
UCSF School of Medicine, San Francisco, California, United States
Children's Hospital Colorado, Denver, Colorado, United States
Children's National Medical Center, Washington, District of Columbia, United States
University of Miami, Miami, Florida, United States
Children's Healthcare of Atlanta, Emory University, Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States
Riley Hospital for Children, Indianapolis, Indiana, United States
Johns Hopkins University, Baltimore, Maryland, United States
National Cancer Institute, Pediatric Oncology Branch, Bethesda, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
C.S. Mott Children's Hospital, Ann Arbor, Michigan, United States
Children's Hospital and Clinics of Minnesota, Minneapolis, Minnesota, United States
Children's Hospital New York-Presbyterian, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Carolina-Levine Children's Hospital, Charlotte, North Carolina, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Rainbow Babies, Cleveland, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Oregon Health & Science University, Portland, Oregon, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
University of Texas, Southwestern, Dallas, Texas, United States
Cook Children's Hospital, Fort Worth, Texas, United States
Texas Children's Hospital/Baylor College of Medicine, Houston, Texas, United States
Primary Children's Hospital, Salt Lake City, Utah, United States
Seattle Children's Hospital, Seattle, Washington, United States
Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States
Children's Hospital at Westmead, Westmead, New South Wales, Australia
Sydney Children's Hospital, Sydney, , Australia
Contact Details
Name: Adam Lamble, MD
Affiliation: Seattle Children's
Role: STUDY_CHAIR
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