Spots Global Cancer Trial Database for Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With UK ALL R3 Induction Chemotherapy for Children, Adolescents, and Young Adults With Relapsed ALL
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Trial Identification
Brief Title: Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With UK ALL R3 Induction Chemotherapy for Children, Adolescents, and Young Adults With Relapsed ALL
Official Title: A Pilot Study of Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With UK ALL R3 Induction Chemotherapy for Children, Adolescents, and Young Adults With Relapse of Acute Lymphoblastic Leukemia
Study ID: NCT02879643
Interventions
Study Description
Brief Summary: This is a pilot study utilizing Marqibo® (vincristine sulfate liposome injection) combined with dexamethasone, mitoxantrone and asparaginase (UK ALL R3) for relapsed acute lymphoblastic leukemia (ALL).
Detailed Description: This study will utilize Marqibo® as a replacement for standard vincristine in combination with chemotherapy for children with relapsed ALL. The hypothesis is that the incorporation of Marqibo® with combination chemotherapy will be safe and feasible. In the context of this pilot study, overall outcomes and efficacy will be a secondary objective. It is hypothesized that data from this combination may show improved efficacy including, complete remission (CR), minimal residual disease (MRD) negativity, and progression free survival (PFS) rates and safety (i.e., neurotoxicity) in comparison to outcomes in historical regimens, including the UK ALL R3 with standard vincristine.
Keywords
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Childrens 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
The Children's Hospital, University of Colorado, Aurora, Colorado, United States
Children's National Medical Center, Washington, District of Columbia, United States
University of Miami, Miami, Florida, United States
All Children's Hospital, Saint Petersburg, Florida, United States
Children's Healthcare of Atlanta at Egleston, Atlanta, Georgia, United States
Lurie Children's Hospital of Chicago, Chicago, Illinois, United States
Sidney Kimmel Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
National Cancer Institute, Pediatric Oncology Branch, Bethesda, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
CS Mott Children's Hospital, Ann Arbor, Ann Arbor, Michigan, United States
Children's Hospitals and Clinics of Minnesota, Minneapolis, Minnesota, United States
Children's Hospital New York-Presbyterian, New York, New York, United States
Levine Children's Hospital, Charlotte, North Carolina, United States
Cincinnati Children's Hospital, Cincinnati, Ohio, United States
Rainbow Babies & Children's Hospital, 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
Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville, Tennessee, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Cook Children's Medical Center, Fort Worth, Texas, United States
Texas Children's Cancer Center, Baylor, Houston, Texas, United States
Primary Children's Hospital, Salt Lake City, Utah, United States
Seattle Children's Hospital, Seattle, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Sydney Children's Hospital, Randwick, New South Wales, Australia
The Children's Hospital at Westmead, Westmead, New South Wales, Australia
Lady Cilento Children's Hospital, South Brisbane, Queensland, Australia
Royal Children's Hospital, Melbourne, Parkville,, Victoria, Australia
British Columbia Children's Hospital, Vancouver, British Columbia, Canada
Hospital for Sick Children, Toronto, Ontario, Canada
Sainte-Justine University Hospital Center, Montréal, Québec, , Canada
Contact Details
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