Last updated on January 2020

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


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT03384654

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Phoenix Children's Hospital

Phoenix, AZ United States
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Stanford University

Palo Alto, CA United States
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Riley Hospital for Children

Indianapolis, IN United States
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Johns Hopkins University

Baltimore, MD United States
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C.S. Mott Children's Hospital

Ann Arbor, MI United States
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Baylor College of Medicine

Houston, TX United States
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Medical College Of Wisconsin

Milwaukee, WI United States
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H pital D'Enfants

Vandoeuvre les Nancy, France
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Hosp. Sant Joan de Deu

Esplugues de Llobregat, Spain
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Royal Marsden Hospital

Surrey, United Kingdom
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H pital D'Enfants

Vandoeuvre Les Nancy, France
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Hosp. Sant Joan de Deu

Esplugues De Llobregat, Spain
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