Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma
Key facts
- Where
- Barcelona, L'Hospitalet de Llobregat, Madrid és Salamanca, SpanyolországSee the 6 sites
- Phase
- 2. fázis
Where in Spanyolország
- Hospital del MarBarcelona, SpanyolországNo longer taking part
- Hospital Universitari Vall d'HebronBarcelona, SpanyolországNo longer taking part
- Institut Catala D'oncologiaL'Hospitalet de Llobregat, SpanyolországNo longer taking part
- Hospital Universitario 12 de OctubreMadrid, SpanyolországNo longer taking part
- Hospital Universitario Fundación Jiménez DíazMadrid, SpanyolországNo longer taking part
- Hospital Universitario De SalamancaSalamanca, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Seagen Inc.
- Trial code
- EU 2023-503387-16-00
- Record updated
- 2024. június 10.
- Original description
Parts C: To assess the complete response (CR) rate at EOT with AN+AD in subjects with previously untreated cHLRead full original descriptionShow less
Multiple Part Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma Subjects
Parts C: To assess the complete response (CR) rate at EOT with AN+AD in subjects with previously untreated cHL
Inclusion: Treatment-naïve, cHL subjects: Subjects enrolling in Part C of the study must have Ann Arbor Stage I or II cHL without bulky mediastinal disease; Histologically confirmed cHL according to the current World Health Organization Classification; Bidimensional measurable disease as documented by PET/CT or CT imaging; Age 12 years or older in the United States. For regions outside of the United States, subjects must be age 18 years or older; An Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Exclusion: Documented history of a cerebral vascular event within 6 months prior to their first dose of brentuximab vedotin; Subjects with acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment for or prophylaxis agent against GvHD; Previous treatment with brentuximab vedotin; Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy within 4 weeks of first study drug dose; Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting Tcell co-stimulation or checkpoint pathways; Any active Grade 3 or higher (per the National Cancer Institute's Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 4.03) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study drug; Current therapy with other systemic anti-neoplastic or investigational agents; Planned consolidative radiotherapy during the study treatment period (Parts B and C only); Grade 3 or higher pulmonary disease unrelated to underlying malignancy; Subjects with Child-Pugh B or C hepatic impairment; History of another malignancy within 3 years before the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death. Subjects with nonmelanoma skin cancer, localized prostate cancer, or carcinoma in situ of any type are not excluded if they have undergone complete resection; Active cerebral/meningeal disease related to the underlying malignancy; Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity (Parts B and C only); Nodular lymphocyte predominant HL; Idiopathic interstitial pneumonia or diffusing capacity of the lung for carbon monoxide <50% predicted; Grade 2 or higher peripheral sensory or motor neuropathy at baseline; Subjects who are pregnant or breastfeeding.