Brentuximab vedotin+Adriamycin, vinblastine, and dacarbazine in pediatric patients with advanced stage newly diagnosed Hodgkin lymphoma

Phase 1

• Conditions: Hodgkin lymphoma (HL), a neoplasm of lymphoid tissue which is histopathologically defined by the presence of malignant Hodgkin Reed-Sternberg (HRS) cells in a background of inflammatory cells.The proposed pediatric study has been designed to evaluate brentuximab vedotin as a component of a multiagent frontline chemotherapy regimen in patients with advanced stage, newly diagnosed HL, here defined as Stage III and Stage IV and a =50 Lansky Play-Performance or Karnofsky Performance Status.; MedDRA version: 19.0Level: HLGTClassification code 10025319Term: Lymphomas Hodgkin's diseaseSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-004112-38-ES
• Lead Sponsor: Millennium Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-17
• Study Completion: 2021-09-24
• Last Update Posted: 8 August 2022

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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 61
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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