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Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma
EU CTIS ID: 2023-503387-16-00
What this study is testing
Parts C: To assess the complete response (CR) rate at EOT with AN+AD in subjects with previously untreated cHL
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Australia
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Australia; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.