Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma
Reason given: The study was prematurely discontinued as the sponsor believes the data collected is enough to show the safety and efficacy of the combinations studied in all cohorts. The decision was not based on any safety and/or efficacy concerns.
Key facts
- Where
- Albany, Aurora, Austin, Boston, Brick, Charleston, Cincinnati, Cleveland, Colorado Springs, Dallas, Denver, Detroit, Edina, Eugene, Fairfax, Flower Mound, Fort Collins, Fort Sam Houston, Fort Worth, Fountain Valley, Freehold, Grand Junction, Hackensack, Houston, Howell Township, Kennewick, Knoxville, Maywood, Miami, Morristown, Mount Holly, Mount Kisco, Nashville, New York, Niles, Olympia, Peoria, Portland, Purchase, Salem, Salt Lake City, San Antonio, Seattle, Somerville, Sparta, St Louis, St. Petersburg, Toledo, Tyler, Westbury, and Winston-Salem, United StatesSee the 55 sites
- Phase
- Phase 2
Where in United States
- New York Oncology Hematology, P.C.Albany, United StatesNo longer taking part
- Rocky Mountain Cancer Centers-AuroraAurora, United StatesNo longer taking part
- Texas Oncology-Austin MidtownAustin, United StatesNo longer taking part
- Beth Israel Deaconess Medical CenterBoston, United StatesNo longer taking part
- Massachusetts General HospitalBoston, United StatesNo longer taking part
- New Jersey Hematology Oncology Associates LLCBrick, United StatesNo longer taking part
- Medical University of South Carolina - Hollings Cancer CenterCharleston, United StatesNo longer taking part
- Oncology Hematology CareCincinnati, United StatesNo longer taking part
- Cleveland Clinic, TheCleveland, United StatesNo longer taking part
- University Hospitals Cleveland Medical Center*Cleveland, United StatesNo longer taking part
- University of Colorado Health Memorial HospitalColorado Springs, United StatesNo longer taking part
- Texas Oncology-Medical City DallasDallas, United StatesNo longer taking part
- Cancer Centers of Colorado - DenverDenver, United StatesNo longer taking part
- Henry Ford Health SystemDetroit, United StatesNo longer taking part
- Karmanos Cancer Institute - Wayne State UniversityDetroit, United StatesNo longer taking part
- Minnesota Oncology Hematology P AEdina, United StatesNo longer taking part
- Willamette Valley Cancer Institute and Research CenterEugene, United StatesNo longer taking part
- Virginia Cancer Specialists PCFairfax, United StatesNo longer taking part
- Texas Oncology-Flower MoundFlower Mound, United StatesNo longer taking part
- Poudre Valley Health System (PVHS)Fort Collins, United StatesNo longer taking part
- Brooke Army Medical CenterFort Sam Houston, United StatesNo longer taking part
- Texas Oncology - Fort Worth 12th AvenueFort Worth, United StatesNo longer taking part
- Los Angeles Cancer Network / Compassionate Care Research GroupFountain Valley, United StatesNo longer taking part
- Regional Cancer Care Associates-FreeholdFreehold, United StatesNo longer taking part
- SCL Health - St. Mary's Hospital & Medical CenterGrand Junction, United StatesNo longer taking part
- Hackensack University Medical CenterHackensack, United StatesNo longer taking part
- MD Anderson Cancer Center - University of TexasHouston, United StatesNo longer taking part
- Regional Cancer Care Associates - HowellHowell Township, United StatesNo longer taking part
- Kadlec Clinic Hematology and OncologyKennewick, United StatesNo longer taking part
- University of TennesseeKnoxville, United StatesNo longer taking part
- Cardinal Bernardin Cancer Center / Loyola University Medical CenterMaywood, United StatesNo longer taking part
- Miami Cancer Institute at Baptist Health, Inc.Miami, United StatesNo longer taking part
- Morristown Medical Center/ Carol G. Simon Cancer CenterMorristown, United StatesNo longer taking part
- Regional Cancer Care Associates - Mount HollyMount Holly, United StatesNo longer taking part
- CareMount Medical GroupMount Kisco, United StatesNo longer taking part
- Tennessee Oncology-Nashville/Sarah Cannon Research InstituteNashville, United StatesNo longer taking part
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesNo longer taking part
- Mount SInai Medical CenterNew York, United StatesNo longer taking part
- Illinois Cancer SpecialistsNiles, United StatesNo longer taking part
- Vista Oncology Inc PSOlympia, United StatesNo longer taking part
- Illinois Cancer CarePeoria, United StatesNo longer taking part
- Providence Portland Medical CenterPortland, United StatesNo longer taking part
- Clinical Research Alliance - Abraham Mittelman, MD, LLCPurchase, United StatesNo longer taking part
- Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer CareSalem, United StatesNo longer taking part
- Huntsman Cancer Institute/University of UtahSalt Lake City, United StatesNo longer taking part
- Texas Oncology - San Antonio Medical CenterSan Antonio, United StatesNo longer taking part
- Seattle Cancer Care Alliance- University of WashingtonSeattle, United StatesNo longer taking part
- Regional Cancer Care Associates - Central JerseySomerville, United StatesNo longer taking part
- Regional Cancer Care Associates - SpartaSparta, United StatesNo longer taking part
- Washington University in St. LouisSt Louis, United StatesNo longer taking part
- Florida Cancer Specialists - North RegionSt. Petersburg, United StatesNo longer taking part
- Toledo Clinic Cancer CenterToledo, United StatesNo longer taking part
- Texas Oncology - Northeast TexasTyler, United StatesNo longer taking part
- Clinical Research Alliance - Morton Coleman, MDWestbury, United StatesNo longer taking part
- Wake Forest Baptist Medical Center / Wake Forest UniversityWinston-Salem, United StatesNo longer taking part
Trial details
- Who runs it
- Seagen Inc.
- Trial code
- NCT03646123
- Record updated
- 28 August 2025
- Original description
This trial will study two treatment combinations for classical Hodgkin lymphoma (cHL). This trial will find out if these two treatment combinations work to treat cHL. It will also find out what side effects occur. A side effect is anything the drug does besides treating cancer. This study will have three parts (Parts A, B, and C).Read full original descriptionShow less
Multiple Part Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma Subjects
This trial will study two treatment combinations for classical Hodgkin lymphoma (cHL). This trial will find out if these two treatment combinations work to treat cHL. It will also find out what side effects occur. A side effect is anything the drug does besides treating cancer. This study will have three parts (Parts A, B, and C).
The drugs used in Part A are a combination of targeted anticancer drug (brentuximab vedotin) and three chemotherapy drugs (doxorubicin, vinblastine, and dacarbazine). These four drugs are called "A+AVD." Participants will be treated with granulocyte colony stimulating factor (G-CSF) following every dose of A+AVD for 6 cycles of treatment (12 doses).
Part A will look at whether the A+AVD drug combination reduces the number of participants who experience the side effect of febrile neutropenia. Febrile neutropenia is a very low white blood cell count and a fever, which can be life threatening.
Parts B and C will use drug combination of brentuximab vedotin, plus nivolumab, doxorubicin, and dacarbazine. These four drugs are called "AN+AD." Parts B and C will study how well the drugs work to treat cHL and what side effects they cause.
Inclusion: 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: 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; Current therapy with other systemic anti-neoplastic or investigational agents; Planned consolidative radiotherapy (Parts B and C only); 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; 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; 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); 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; Other serious condition that would impair the participant's ability to receive or tolerate the planned treatment and follow-up; Nodular lymphocyte predominant HL; Grade 2 or higher peripheral sensory or motor neuropathy; Participants who are pregnant or breastfeeding.