Spots Global Cancer Trial Database for PO Ixazomib in Combination With Chemotherapy for Childhood Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
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Trial Identification
Brief Title: PO Ixazomib in Combination With Chemotherapy for Childhood Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
Official Title: A TACL Phase 1/2 Study of PO Ixazomib in Combination With Chemotherapy for Childhood Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma IND# 140730
Study ID: NCT03817320
Study Description
Brief Summary: This is a phase 1/2 study of a drug called Ixazomib in combination with cytotoxic chemotherapy consisting of Vincristine, Dexamethasone, Asparaginase, and Doxorubicin (VXLD).
Detailed Description: The phase 1 study is to determine the maximum tolerated dose (MTD) of the PO formulation, followed by a screening phase 2 study to investigate the efficacy of ixazomib in combination with chemotherapy in children with relapsed ALL and lymphoblastic lymphoma (LLy). The single arm, screening phase 2 design will allow us to use a minimal number of patients to obtain preliminary information about treatment efficacy. Discovering a safe and tolerable dose of ixazomib in a PO formulation and the preliminary efficacy data will significantly increase the possibility of ixazomib moving forward in frontline pediatric treatment protocols in both intense chemotherapy courses and maintenance courses.
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
Children's National Medical Center, Washington, District of Columbia, United States
University of Miami, Miami, Florida, United States
Children's Healthcare of Atlanta, Atlanta, Georgia, United States
C.S. Mott Children's Hospital, Ann Arbor, Michigan, United States
Children's Hospital and Clinics of Minnesota, Minneapolis, Minnesota, United States
Columbia University Medical Center, New York, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
University Hospitals Seidman Cancer Center, Cleveland, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Doernbecher Children's Hospital, 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 Medical Center, Fort Worth, Texas, United States
Texas Children's Hospital/Baylor University, Houston, Texas, United States
The Children's Hospital at Westmead, Westmead, New South Wales, Australia
Contact Details
Name: Terzah Horton, MD
Affiliation: Baylor College of Medicine
Role: STUDY_CHAIR
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