Classical Hodgkin Lymphoma MedDRA version: 20.1 Level: LLT Classification code 10080208 Term: Classical Hodgkin lymphoma System Organ Class: 100000004864
Conditions
Sponsors
Seagen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Treatment-naïve, cHL subjects: Subjects enrolling in Part C of the study must have Ann Arbor Stage I or II cHL without bulky 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. Other protocol defined inclusion criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: • Nodular lymphocyte predominant HL • 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 T-cell 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). • Grade 3 or higher pulmonary disease unrelated to underlying malignancy. • Documented history of 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. Other protocol defined exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Parts C: To assess the complete response (CR) rate at EOT with AN+AD in subjects with previously untreated cHL;Secondary Objective: Parts C: ? To assess the safety and tolerability of AN+AD ? To assess the overall response rate (ORR) ? To assess the duration of response (DOR) ? To assess the duration of complete response (DOCR) ? To assess the event-free survival (EFS) ? To assess the progression-free survival (PFS) ? To assess the overall survival (OS);Primary end point(s): CR rate at EOT;Timepoint(s) of evaluation of this end point: Up to 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Incidence, severity, seriousness, and relatedness of AEs; incidence and severity of lab abnormalities ? Estimate the ORR ? DOR ? DOCR ? EFS ? PFS;Timepoint(s) of evaluation of this end point: ? Up to 7 months ? Up to 6 months ? Up to 5 years ? Up to 5 years ? Up to 5 years ? Up to 5 years ? Up to 5 years | — |
Countries
Australia, Canada, Czechia, Czech Republic, Italy, Poland, Spain, United States
Contacts
Public ContactSeagen Clinical Trial Information
Seagen Inc.
Outcome results
None listed