A Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Participants With Advanced Stage Newly Diagnosed Hodgkin Lymphoma
NCT02979522 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 59
Last updated 2025-11-10
Summary
The purpose of this study is to assess the safety, tolerability, and anti-tumor activity, as well as confirm the recommended dose of brentuximab vedotin (ADCETRIS) in combination with a multiagent chemotherapy regimen, doxorubicin (Adriamycin), vinblastine, and dacarbazine, in pediatric participants with advanced stage newly diagnosed classical CD30+ Hodgkin Lymphoma (HL).
Conditions
- Hodgkin Disease
Interventions
- DRUG
-
Brentuximab vedotin
Brentuximab vedotin infusion
- DRUG
-
Doxorubicin
Doxorubicin infusion
- DRUG
-
Vinblastine
Vinblastine infusion
- DRUG
-
Dacarbazine
Dacarbazine infusion
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Study Director · Takeda
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 5 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-09-06
- Primary Completion
- 2020-05-05
- Completion
- 2029-09-24
- FDA Drug
- Yes
Countries
- United States
- Brazil
- Italy
- Japan
Study Locations
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