NCT03384654

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 1 Year – 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Type	Name	Description
DRUG	Daratumumab	Participant will receive daratumumab 16 milligram per kilogram (mg/kg) in cohort 1 and cohort 2.
DRUG	Vincristine	Participant will receive vincristine 1.5 milligram per meter square (mg/m\^2) in cohort 1 and cohort 2.
DRUG	Prednisone	Participant will receive prednisone 40 mg/m\^2 in cohort 1 and cohort 2.
DRUG	Doxorubicin	Participant will receive doxorubicin 60 mg/m\^2 in cohort 2.
BIOLOGICAL	Peg-asparaginase	Participant will receive peg-asparaginase 2500 units per meter square (U/m\^2) in cohort 2.
DRUG	Cyclophosphamide	Participant will receive cyclophosphamide 1 gram per meter square (g/m\^2) once in cohort 2.
DRUG	Cytarabine	Participant will receive cytarabine 75 mg/m\^2 in cohort 2.
DRUG	6-mercaptopurine	Participant will receive 6-mercaptopurine 60 mg/m\^2 orally daily in cohort 2.
DRUG	Methotrexate	Participant will receive methotrexate 5 g/m\^2 intravenously (IV) in cohort 2.

Timeline

• Start date: 2018-05-14
• Primary completion: 2022-09-22
• Completion: 2022-09-27
• First posted: 2017-12-27
• Last updated: 2025-05-25
• Results posted: 2023-10-13

Locations

53 sites across 10 countries: United States, Belgium, France, Germany, Israel, Italy, Netherlands, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study