Brentuximab vedotin+Adriamycin, vinblastine, and dacarbazine in pediatric patients with advanced stage newly diagnosed Hodgkin lymphoma
Phase 1
- Registration Number
- CTIS2023-506415-18-00
- Lead Sponsor
- Takeda Development Center Americas Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 59
Inclusion Criteria
Main Criteria for Inclusion: Male or female patients aged 5 to <18 years with newly diagnosed classical CD30+ advanced stage (Stage III and Stage IV) HL who are treatment naïve with Karnofsky Performance Status or Lansky Play- Performance =50.
Exclusion Criteria
Main Criteria for Exclusion: Patients may not have nodular lymphocyte-predominant HL, known active cerebral meningeal disease, including signs or symptoms of progressive multifocal leukoencephalopathy (PML) or any history of PML, sensory or motor peripheral neuropathy, or known hypersensitivity to brentuximab vedotin or any component of AVD.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method