Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma
Hodgkin Lymphoma
About this trial
This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring Brentuximab vedotin, Doxorubicin, Vinblastine, Dacarbazine, Nivolumab, Seattle Genetics
Eligibility Criteria
Inclusion Criteria
Treatment-naïve, classic Hodgkin lymphoma (cHL) participants
- Participants enrolling in Part A of the study must have Ann Arbor Stage III or IV disease
- Participants enrolling in Part B of the study must have Ann Arbor Stage I or II cH: with bulky mediastinal disease, or Stage III or IV
- Participants 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 (WHO) 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 US, participants must 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Exclusion Criteria
- Nodular lymphocyte predominant HL
- History of another malignancy within 3 years of the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk or metastasis or death. Participants 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 the 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 viral, bacterial, or fungal infection within two weeks of the first dose of study drug (Grade 3 defined by the National Cancer Institute's Common Terminology Criteria for Adverse Events, NCI CTCAE Version 4.03)
- Current therapy with other systemic anti-neoplastic or investigational agents
- Planned consolidative radiotherapy (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
- History of a cerebral vascular event within 6 months of first dose of study drug
- Child-Pugh B or C hepatic impairment
- Grade 2 or higher peripheral sensory or motor neuropathy
- Participants with acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment or as prophylaxis against GvHD
- Previous treatment with brentuximab vedotin
- Participants who are pregnant or breastfeeding
- Other serious condition that would impair the participant's ability to receive or tolerate the planned treatment and follow-up
Sites / Locations
- Compassionate Care Research Group
- Rocky Mountain Cancer Centers - Aurora
- University of Colorado Health Memorial Hospital
- Cancer Centers of Colorado - Denver
- Poudre Valley Health System (PVHS)
- SCL Health - St. Mary's Hospital & Medical Center
- Miami Cancer Institute at Baptist Health, Inc.
- Florida Cancer Specialists - North Region
- Cardinal Bernardin Cancer Center / Loyola University Medical Center
- Illinois Cancer Specialists
- Illinois Cancer Care
- Massachusetts General Hospital
- Beth Israel Deaconess Medical Center
- Karmanos Cancer Institute / Wayne State University
- Henry Ford Health System
- Minnesota Oncology Hematology P.A.
- Washington University in St Louis
- New Jersey Hematology Oncology Associates, LLC
- Regional Cancer Care Associates - Freehold
- Hackensack University Medical Center
- Regional Cancer Care Associates - Howell
- Morristown Medical Center/ Carol G. Simon Cancer Center
- Regional Cancer Care Associates - Mount Holly
- Regional Cancer Care Associates - Central Jersey
- Regional Cancer Care Associates - Sparta
- New York Oncology Hematology, P.C.
- CareMount Medical Group
- Mount Sinai Medical Center
- Memorial Sloan Kettering Cancer Center
- Clinical Research Alliance - Abraham Mittelman, MD, LLC
- Clinical Research Alliance - Morton Coleman, MD
- Wake Forest Baptist Medical Center / Wake Forest University
- Oncology Hematology Care
- Case Western Reserve University / University Hospitals Cleveland Medical Center
- Cleveland Clinic, The
- Toledo Clinic Cancer Center
- Willamette Valley Cancer Institute and Research Center
- Providence Portland Medical Center
- Medical University of South Carolina/Hollings Cancer Center
- University of Tennessee
- Tennessee Oncology-Nashville/Sarah Cannon Research Institute
- Texas Oncology - Austin Midtown
- Texas Oncology - Medical City Dallas
- Texas Oncology - Flower Mound
- Brooke Army Medical Center
- Texas Oncology - Fort Worth 12th Avenue
- MD Anderson Cancer Center / University of Texas
- Texas Oncology - San Antonio Medical Center
- Texas Oncology - Northeast Texas
- Huntsman Cancer Institute/University of Utah
- Virginia Cancer Specialists, PC
- Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care
- Kadlec Clinic Hematology and Oncology
- Vista Oncology Inc PS
- Seattle Cancer Care Alliance / University of Washington
- Royal Adelaide Hospital
- Ballarat Regional Integrated Cancer Care
- Monash Medical Centre
- Epworth Healthcare
- Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie
- Fakultni Nemocnice Kralovske Vinohrady
- Azienda Ospedaliera Spedali Civili di Brescia
- IRCSS Policlinico San Matteo
- Azienda Ospedaliera Universitaria Senese
- Azienda Ospedaliera Citta della Salute e della Scienza di Torino
- Pratia MCM Krakow
- Hospital del Mar
- Hospital Universitario Vall d'Hebron
- Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
- Hospital Universitario de Girona Doctor Josep Trueta
- Hospital Universitario Fundacion Jimenez Diaz
- Hospital Universitario 12 de Octubre
- Hospital Puerta de Hierro Majadahonda
- Hospital Universitario Central de Asturias
- Hospital Clinico Universitario de Salamanca
- Hospital Universitari i Politecnic La Fe de Valencia
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Part A: A+AVD
Part B: AN+AD
Part C: AN+AD
Brentuximab vedotin (A) plus doxorubicin (+A), vinblastine (V), and dacarbazine (D) administered by intravenous (IV) infusion in participants with advanced stage classical Hodgkin lymphoma (cHL) during each treatment cycle.
Brentuximab vedotin (A) plus nivolumab (N), doxorubicin (+A), and dacarbazine (D) administered separately by IV infusion in participants with Stage II bulky mediastinal disease and Stage III or IV cHL during each treatment cycle.
Brentuximab vedotin (A) plus nivolumab (N), doxorubicin (+A), and dacarbazine (D) administered separately by IV infusion in participants with Stage I or II cHL with non-bulky mediastinal disease during each treatment cycle.