Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma
- Conditions
- Classical Hodgkin LymphomaMedDRA version: 20.0Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-004027-17-IT
- Lead Sponsor
- SEAGEN INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 200
• Treatment-naïve, cHL subjects:
a. Subjects enrolling in Part B of the study must have Ann Arbor Stage I or II cHL with bulky mediastinal disease, or Stage III or IV disease.
b. 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.
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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
• 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 antiCTLA-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).
• 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.
Other protocol defined exclusion criteria may apply.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Parts B and C: To assess the complete response (CR) rate at EOT with AN+AD in subjects with previously untreated cHL;Secondary Objective: Parts B and C:<br>To assess the safety and tolerability of AN+AD<br>- To assess the overall response rate (ORR)<br>- To assess the duration of response (DOR)<br>- To assess the duration of complete response (DOCR)<br>- To assess the event-free survival (EFS)<br>- To assess the progression-free survival (PFS)<br>- To assess the overall survival (OS);Primary end point(s): CR rate at EOT;Timepoint(s) of evaluation of this end point: Fino a 6 mesi
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Incidence, severity, seriousness, and relatedness of AEs; incidence and severity of lab abnormalities<br>- Estimate the ORR<br>- DOR<br>- DOCR<br>- EFS<br>- PFS;Timepoint(s) of evaluation of this end point: - Up to 7 months<br>- Up to 6 months<br>- Up to 5 years<br>- Up to 5 years<br>- Up to 5 years<br>- Up to 5 years<br>- Up to 5 years