Spots Global Cancer Trial Database for A Study of Venetoclax in Combination With Navitoclax and Chemotherapy in Subjects With Relapsed/Refractory Acute Lymphoblastic Leukemia or Relapsed/Refractory Lymphoblastic Lymphoma
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Trial Identification
Brief Title: A Study of Venetoclax in Combination With Navitoclax and Chemotherapy in Subjects With Relapsed/Refractory Acute Lymphoblastic Leukemia or Relapsed/Refractory Lymphoblastic Lymphoma
Official Title: A Phase 1 Dose Escalation, Open-Label Study of Venetoclax in Combination With Navitoclax and Chemotherapy in Subjects With Relapsed/Refractory Acute Lymphoblastic Leukemia or Relapsed/Refractory Lymphoblastic Lymphoma
Study ID: NCT03181126
Study Description
Brief Summary: This dose-escalating study is to determine the safety, pharmacokinetics, and preliminary efficacy of venetoclax in combination with navitoclax and chemotherapy in adult and pediatric participants with relapsed/refractory acute lymphoblastic leukemia (ALL) or relapsed/refractory lymphoblastic lymphoma. A safety expansion cohort of approximately 20 patients may be enrolled in addition to the 50 participants in dose-escalation cohort.
Detailed Description:
Eligibility
Minimum Age: 4 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope /ID# 169029, Duarte, California, United States
LPCH Stanford /ID# 163337, Palo Alto, California, United States
University of Chicago /ID# 163369, Chicago, Illinois, United States
Washington University-School of Medicine /ID# 165689, Saint Louis, Missouri, United States
Univ NC Chapel Hill /ID# 163509, Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital /ID# 164619, Cincinnati, Ohio, United States
Nationwide Childrens Hospital /ID# 163372, Columbus, Ohio, United States
Oregon Health and Science University /ID# 165690, Portland, Oregon, United States
St Jude Children's Research Hospital /ID# 163335, Memphis, Tennessee, United States
UT Southwestern Medical Center /ID# 163346, Dallas, Texas, United States
MD Anderson Cancer Center at Texas Medical Center /ID# 163327, Houston, Texas, United States
University of Wisconsin-Madiso /ID# 165691, Madison, Wisconsin, United States
Alfred Hospital /ID# 169576, Melbourne, Victoria, Australia
Victorian Comprehensive Cancer /ID# 165710, Melbourne, Victoria, Australia
Royal Children's Hospital /ID# 163322, Melbourne, Victoria, Australia
Contact Details
Name: AbbVie Inc.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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