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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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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