A Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Participants With Advanced Stage Newly Diagnosed Hodgkin Lymphoma

Status: Active

Description

The purpose of this study is to assess the safety, tolerability, and anti-tumor activity, as well as 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).

Eligibility Criteria

Inclusion Criteria

  • Inclusion Criteria: Each participant must meet all the following inclusion criteria to be enrolled in the study: 1. Histologically confirmed CD30+ classical HL. 2. Advanced stage, newly diagnosed HL (Stage III and Stage IV disease). 3. Treatment-naive HL. 4. Have performance scores of greater than or equal to (>=) 50 for Lansky Play-performance or Karnofsky Performance Status. Exclusion Criteria: 1. Nodular lymphocyte predominant HL. 2. Known active cerebral/meningeal disease, including signs or symptoms of progressive multifocal leukoencephalopathy (PML) or any history of PML. 3. Any sensory or motor peripheral neuropathy. 4. Symptomatic neurologic disease compromising normal activities of daily living or requiring medications.

Locations & Contacts

Colorado

Aurora
Children's Hospital Colorado
Status: Active
Name Not Available

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available

Trial Objectives and Outline

The drug being tested in this study is called brentuximab vedotin. Brentuximab vedotin is being tested to treat pediatric participants who have advanced stage, newly diagnosed, classical CD30+ HL. This study will assess the safety, tolerability, and anti-tumor activity, as well as recommended dose of brentuximab vedotin in combination with a multiagent chemotherapy regimen that is based on a current standard of care (SOC) first-line treatment regimen for newly diagnosed HL. The study will enroll approximately 55 evaluable participants. The study will be conducted in 2 phases, Phase 1 and Phase 2. Phase 1 study will enroll up to 12 participants to determine the recommended dose. Once the recommended dose is identified additional participants will be enrolled into phase 2 so that the total number of evaluable participants will be approximately 55, including participants treated at recommended dose in Phase 1. Participants will be enrolled in the following 2 dose Cohorts: • Brentuximab vedotin 48 mg/m^2 or 36 mg/m^2 in combination with doxorubicin, vinblastine, and dacarbazine. Phase 1 has completed enrollment and Phase 2 is now open for enrollment. This multi-center trial will be conducted in United States (US), Italy, Brazil, Japan, Taiwan, Singapore, and Hong Kong. The overall time to participate in this study is approximately 55 months, including the follow-up period. Participants will be followed for a maximum of 30 days following the last dose of protocol therapy for a follow-up assessment and will be followed for survival until death or study closure or a maximum of 2 years after enrollment of the last participant.

Trial Phase & Type

Trial Phase

Phase I/II

Trial Type

Treatment

Lead Organization

Lead Organization
Millennium Pharmaceuticals, Inc.

Trial IDs

Primary ID C25004
Secondary IDs NCI-2017-01241, U1111-1171-0984, 2015-004112-38
Clinicaltrials.gov ID NCT02979522