Spots Global Cancer Trial Database for A Study to Evaluate the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Participants Greater Than or Equal to (>=)1 and Less Than or Equal to (<=) 30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
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Trial Identification
Brief Title: A Study to Evaluate the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Participants Greater Than or Equal to (>=)1 and Less Than or Equal to (<=) 30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Official Title: An Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Subjects >=1 and <=30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Study ID: NCT03384654
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy of daratumumab in addition to standard chemotherapy in pediatric participants with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LL) and T-cell ALL/LL as measured by the complete response (CR) rate.
Detailed Description: Screening for eligible participants will be performed within 21 days before administration of the study drug. Participants with B-cell ALL/LL will receive treatment until disease progression, unacceptable toxicity or achievement of CR followed by hematopoietic stem cell transplant (HSCT). Participants with T cell ALL/LL will receive treatment for up to 2 cycles. If disease progression is confirmed, then the participant will discontinue study treatment, complete the End of Treatment Visit, and enter the Posttreatment Period. For those participants who discontinue study drug prior to disease progression, disease evaluations will continue to be performed every 8 weeks until subsequent anticancer therapy is initiated.
Keywords
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
Phoenix Children's Hospital, Phoenix, Arizona, United States
UCSF Benioff Children's Hospital Oakland, Oakland, California, United States
Children's Hospital Orange County, Orange, California, United States
Stanford University, Palo Alto, California, United States
Children's Hospital Colorado, Aurora, Colorado, United States
Connecticut Children's Medical Center, Hartford, Connecticut, United States
Children'S Healthcare Of Atlanta/Emory Univ. Dept. Of Pediatrics, Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States
Riley Hospital for Children, Indianapolis, Indiana, United States
Johns Hopkins University, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
C.S. Mott Children's Hospital, Ann Arbor, Michigan, United States
Washington Univeristy School of Medicine/ Pediatrics, Saint Louis, Missouri, United States
Newark Beth Israel Medical Center, Newark, New Jersey, United States
New York University Langone Medical Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Stony Brook University Medical Center, Stony Brook, New York, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Dell Children's Medical Center of Central Texas/Children's Blood and Cancer Center, Austin, Texas, United States
UT Southwestern Medical Center, Dallas, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
University of Utah Primary Children's Medical Center, Salt Lake City, Utah, United States
Medical College Of Wisconsin, Milwaukee, Wisconsin, United States
Universitair Ziekenhuis Gent - UZ GENT, Gent, , Belgium
CHU de Bordeaux, Hopital des Enfants, Bordeaux, , France
IHOPE - Hospices civils de Lyon, Lyon, , France
Hopital trousseau- APHP, Paris, , France
Hôpital Robert Debré, Paris, , France
Hôpital D'Enfants, Vandoeuvre les Nancy, , France
Charite-Universitätsmedizin Berlin - Berlin, Berlin, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Universitätsklinikum Münster, Münster, , Germany
Schneider Children's Medical Center, Petach Tiquva, , Israel
Istituto Giannina Gaslini, Genova, , Italy
Fondazione MBBM, ASST Monza, Monza, , Italy
Ospedale Pediatrico Bambin Gesù, Roma, , Italy
AOU Città della Salute e della Scienza di Torino, Presidio Ospedale Infantile Regina Margherita, Torino, , Italy
Princess Maxima Center, Utrecht, , Netherlands
Hosp. Univ. Vall D Hebron, Barcelona, , Spain
Hosp. Sant Joan de Deu, Esplugues de Llobregat, , Spain
Hosp. Infantil Univ. Nino Jesus, Madrid, , Spain
Hosp. Univ. I Politecni La Fe, Valencia, , Spain
Karolinska University Hospital, Stockholm, , Sweden
Bristol Royal Hospital for Children, Bristol, , United Kingdom
Royal Hospital for Sick Children, Glasgow, , United Kingdom
Leeds Children's Hospital, Leeds, , United Kingdom
University College London Hospitals, London, , United Kingdom
Great Ormond Street Hospital, London, , United Kingdom
Royal Manchester Children's Hospital, Manchester, , United Kingdom
Royal Marsden Hospital, Surrey, , United Kingdom
Contact Details
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR
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