Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma
- Conditions
- Classical Hodgkin LymphomaMedDRA version: 20.1Level: LLTClassification code: 10080208Term: Classical Hodgkin lymphoma Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-503387-16-00
- Lead Sponsor
- Seagen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 255
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
Nodular lymphocyte predominant HL, Grade 3 or higher pulmonary disease unrelated to underlying malignancy, Idiopathic interstitial pneumonia or diffusing capacity of the lung for carbon monoxide <50% predicted, Documented history of a cerebral vascular event within 6 months prior to their first dose of brentuximab vedotin, Subjects with Child-Pugh B or C hepatic impairment, Grade 2 or higher peripheral sensory or motor neuropathy at baseline, 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, Subjects who are pregnant or breastfeeding, 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, 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, Active cerebral/meningeal disease related to the underlying malignancy., 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), 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)
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