Spots Global Cancer Trial Database for Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients
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Trial Identification
Brief Title: Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients
Official Title: A Phase II Trial of Tisagenlecleucel in First-line High-risk (HR) Pediatric and Young Adult Patients With B-cell Acute Lymphoblastic Leukemia (B-ALL) Who Are Minimal Residual Disease (MRD) Positive at the End of Consolidation (EOC) Therapy
Study ID: NCT03876769
Conditions
Interventions
Study Description
Brief Summary: This is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in de novo HR pediatric and young adult B-ALL patients who received first-line treatment and are EOC MRD positive. The study will have the following sequential phases: screening, pre-treatment, treatment \& follow-up, and survival. After tisagenlecleucel infusion, patient will have assessments performed more frequently in the first month and then at Day 29, then every 3 months for the first year, every 6 months for the second year, then yearly until the end of the study. Efficacy and safety will be assessed at study visits and as clinically indicated throughout the study. The study is expected to end in approximately 8 years after first patient first treatment (FPFT). A post-study long term follow-up safety will continue under a separate protocol per health authority guidelines.
Detailed Description:
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children s Hospital of Alabama, Birmingham, Alabama, United States
Phoenix Children's Hospital, Phoenix, Arizona, United States
City of Hope National Medical, Duarte, California, United States
Childrens Hospital Los Angeles SC CTL019, Los Angeles, California, United States
Mattel Childrens Hospital UCLA, Los Angeles, California, United States
Childrens Hospital of Orange County CHOC Childrens, Orange, California, United States
Rady Children s Hospital CTBM100C2401, San Diego, California, United States
UCSF Medical Center ., San Francisco, California, United States
Stanford University Medical Center ., Stanford, California, United States
Childrens Hospital Colorado ., Aurora, Colorado, United States
Yale School of Medicine, New Haven, Connecticut, United States
Childrens National Hospital, Washington, District of Columbia, United States
Johns Hopkins All Childrens, Saint Petersburg, Florida, United States
Children's Healthcare of Atlanta Emory University IRB, Atlanta, Georgia, United States
Ann and Robert H Lurie Childrens Hospital of Chicago ., Chicago, Illinois, United States
University of Chicago Hospital ., Chicago, Illinois, United States
James Whitcomb Riley Hospital for Children, Indianapolis, Indiana, United States
Norton Children s Hospital, Louisville, Kentucky, United States
Johns Hopkins Oncology Center Cancer Research Building, Baltimore, Maryland, United States
Dana Farber Cancer Institute Dept.of DFCI, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
University of Minnesota CAEB071B2201, Minneapolis, Minnesota, United States
University of Mississippi Medical Center Childrens Hospital ., Jackson, Mississippi, United States
Children s Mercy Hospital, Kansas City, Missouri, United States
St. Louis University/Cardinal Glennon Children's Hospital, Saint Louis, Missouri, United States
Washington Univ School of Medicine CTBM100C2412, Saint Louis, Missouri, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Hackensack Univ Medical Center, Hackensack, New Jersey, United States
Roswell Park Cancer Institute Main Centre, Buffalo, New York, United States
Cohen Children's Medical Center of New York, New Hyde Park, New York, United States
Memorial Sloan Kettering Cancer Ctr ., New York, New York, United States
Columbia University Medical Center Oncology, New York, New York, United States
Duke University Medical Center ., Durham, North Carolina, United States
Cinn Children Hosp Medical Center, Cincinnati, Ohio, United States
Univ Hospital - Cleveland/Rainbow Babies and Children's Hosp Pediatric Nephrology, Cleveland, Ohio, United States
Cleveland Clinic Foundation Main Centre, Cleveland, Ohio, United States
Nationwide Childrens Hospital suite T6B, Columbus, Ohio, United States
Oregon Health and Science University ., Portland, Oregon, United States
Penn State Childrens Hospital, Hershey, Pennsylvania, United States
The Childrens Hosp of Philadelphia Div Gastroint Hepat and Nutr, Philadelphia, Pennsylvania, United States
Medical Uni of South Carolina Medical Univ of SC, Charleston, South Carolina, United States
Monroe Carell Jr Childrens Hospital at Vanderbilt, Nashville, Tennessee, United States
Univ of Texas Southwest Med Center, Dallas, Texas, United States
Texas Children's Cancer and Hematology Center, Houston, Texas, United States
Methodist Children's Hospital ., San Antonio, Texas, United States
University of Utah Clinical Trials Office ., Salt Lake City, Utah, United States
Children's Hospital of Richmond at VCU Pediatric Hematology Oncology, Richmond, Virginia, United States
University of Wisconsin Hospital and Clinics Pharmacy/Drug Shipping Address, Madison, Wisconsin, United States
Childrens Hospital of Wisconsin, Milwaukee, Wisconsin, United States
Novartis Investigative Site, Gent, , Belgium
Novartis Investigative Site, Gent, , Belgium
Novartis Investigative Site, Calgary, Alberta, Canada
Novartis Investigative Site, Toronto, Ontario, Canada
Novartis Investigative Site, Montreal, Quebec, Canada
Novartis Investigative Site, Copenhagen, , Denmark
Novartis Investigative Site, Helsinki, , Finland
Novartis Investigative Site, Paris, , France
Novartis Investigative Site, Frankfurt, , Germany
Novartis Investigative Site, Hamburg, , Germany
Novartis Investigative Site, Muenchen, , Germany
Novartis Investigative Site, Monza, MB, Italy
Novartis Investigative Site, Roma, RM, Italy
Prinses Maxima Centrum voor Kinderoncologie, Utrecht, CS, Netherlands
Novartis Investigative Site, Oslo, , Norway
Novartis Investigative Site, Esplugues De Llobregat, Barcelona, Spain
Novartis Investigative Site, Goteborg, , Sweden
Novartis Investigative Site, Stockholm, , Sweden
Novartis Investigative Site, London, , United Kingdom
Novartis Investigative Site, London, , United Kingdom
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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