NCT02979522Active, not recruitingPhase 1/2
Brentuximab vedotin+Adriamycin, vinblastine, and dacarbazine in pediatric patients with advanced stage newly diagnosed Hodgkin lymphoma
An Open-Label Study of Brentuximab Vedotin+Adriamycin, Vinblastine, and Dacarbazine in Pediatric Patients With Advanced Stage Newly Diagnosed Hodgkin Lymphoma
Source: EU CTIS (euclinicaltrials.eu) · Last updated 4 Feb 2026
Brief summary (registry, in English)
Phase 1 Primary Objective: To assess the safety and tolerability, and to identify the recommended dose of brentuximab vedotin when combined with multiagent chemotherapy regimen AVD for first-line treatment of advanced stage HL in pediatric patients. Phase 2 Primary Objectives: To evaluate the CR rate of pediatric patients with advanced stage HL at the end of protocol therapy. To determine the percentage of patients who are PET- after 2 cycles of protocol therapy. To evaluate the PR rate of pediatric patients with advanced stage HL at the end of protocol therapy. To evaluate the ORR of pediatric patients with advanced stage HL at the end of protocol therapy. To determine the percentage of patients who are able to complete 6 cycles of protocol therapy at the recommended dose.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 17 Oct 2023
- Start date
- 18 Jul 2017
- Lead sponsor
- Takeda Development Center Americas Inc.
- Diseases
- Hodgkin lymphoma, Childhood cancers
- NCT number
- NCT02979522
- EU CT number
- 2023-506415-18-00
- EudraCT number
- 2015-004112-38
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 15
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliera Universitaria Meyer IRCCS Coordinator of this site? Confirm its status | Florence | Italy | Active, not recruiting |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Active, not recruiting |
| Bambino Gesu Childrens Hospital Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.