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Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma

Megadott ok: 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 és Winston-Salem, Egyesült ÁllamokSee the 55 sites
Phase
2. fázis

Where in Egyesült Államok

  • New York Oncology Hematology, P.C.Albany, Egyesült ÁllamokNo longer taking part
  • Rocky Mountain Cancer Centers-AuroraAurora, Egyesült ÁllamokNo longer taking part
  • Texas Oncology-Austin MidtownAustin, Egyesült ÁllamokNo longer taking part
  • Beth Israel Deaconess Medical CenterBoston, Egyesült ÁllamokNo longer taking part
  • Massachusetts General HospitalBoston, Egyesült ÁllamokNo longer taking part
  • New Jersey Hematology Oncology Associates LLCBrick, Egyesült ÁllamokNo longer taking part
  • Medical University of South Carolina - Hollings Cancer CenterCharleston, Egyesült ÁllamokNo longer taking part
  • Oncology Hematology CareCincinnati, Egyesült ÁllamokNo longer taking part
  • Cleveland Clinic, TheCleveland, Egyesült ÁllamokNo longer taking part
  • University Hospitals Cleveland Medical Center*Cleveland, Egyesült ÁllamokNo longer taking part
  • University of Colorado Health Memorial HospitalColorado Springs, Egyesült ÁllamokNo longer taking part
  • Texas Oncology-Medical City DallasDallas, Egyesült ÁllamokNo longer taking part
  • Cancer Centers of Colorado - DenverDenver, Egyesült ÁllamokNo longer taking part
  • Henry Ford Health SystemDetroit, Egyesült ÁllamokNo longer taking part
  • Karmanos Cancer Institute - Wayne State UniversityDetroit, Egyesült ÁllamokNo longer taking part
  • Minnesota Oncology Hematology P AEdina, Egyesült ÁllamokNo longer taking part
  • Willamette Valley Cancer Institute and Research CenterEugene, Egyesült ÁllamokNo longer taking part
  • Virginia Cancer Specialists PCFairfax, Egyesült ÁllamokNo longer taking part
  • Texas Oncology-Flower MoundFlower Mound, Egyesült ÁllamokNo longer taking part
  • Poudre Valley Health System (PVHS)Fort Collins, Egyesült ÁllamokNo longer taking part
  • Brooke Army Medical CenterFort Sam Houston, Egyesült ÁllamokNo longer taking part
  • Texas Oncology - Fort Worth 12th AvenueFort Worth, Egyesült ÁllamokNo longer taking part
  • Los Angeles Cancer Network / Compassionate Care Research GroupFountain Valley, Egyesült ÁllamokNo longer taking part
  • Regional Cancer Care Associates-FreeholdFreehold, Egyesült ÁllamokNo longer taking part
  • SCL Health - St. Mary's Hospital & Medical CenterGrand Junction, Egyesült ÁllamokNo longer taking part
  • Hackensack University Medical CenterHackensack, Egyesült ÁllamokNo longer taking part
  • MD Anderson Cancer Center - University of TexasHouston, Egyesült ÁllamokNo longer taking part
  • Regional Cancer Care Associates - HowellHowell Township, Egyesült ÁllamokNo longer taking part
  • Kadlec Clinic Hematology and OncologyKennewick, Egyesült ÁllamokNo longer taking part
  • University of TennesseeKnoxville, Egyesült ÁllamokNo longer taking part
  • Cardinal Bernardin Cancer Center / Loyola University Medical CenterMaywood, Egyesült ÁllamokNo longer taking part
  • Miami Cancer Institute at Baptist Health, Inc.Miami, Egyesült ÁllamokNo longer taking part
  • Morristown Medical Center/ Carol G. Simon Cancer CenterMorristown, Egyesült ÁllamokNo longer taking part
  • Regional Cancer Care Associates - Mount HollyMount Holly, Egyesült ÁllamokNo longer taking part
  • CareMount Medical GroupMount Kisco, Egyesült ÁllamokNo longer taking part
  • Tennessee Oncology-Nashville/Sarah Cannon Research InstituteNashville, Egyesült ÁllamokNo longer taking part
  • Memorial Sloan-Kettering Cancer CenterNew York, Egyesült ÁllamokNo longer taking part
  • Mount SInai Medical CenterNew York, Egyesült ÁllamokNo longer taking part
  • Illinois Cancer SpecialistsNiles, Egyesült ÁllamokNo longer taking part
  • Vista Oncology Inc PSOlympia, Egyesült ÁllamokNo longer taking part
  • Illinois Cancer CarePeoria, Egyesült ÁllamokNo longer taking part
  • Providence Portland Medical CenterPortland, Egyesült ÁllamokNo longer taking part
  • Clinical Research Alliance - Abraham Mittelman, MD, LLCPurchase, Egyesült ÁllamokNo longer taking part
  • Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer CareSalem, Egyesült ÁllamokNo longer taking part
  • Huntsman Cancer Institute/University of UtahSalt Lake City, Egyesült ÁllamokNo longer taking part
  • Texas Oncology - San Antonio Medical CenterSan Antonio, Egyesült ÁllamokNo longer taking part
  • Seattle Cancer Care Alliance- University of WashingtonSeattle, Egyesült ÁllamokNo longer taking part
  • Regional Cancer Care Associates - Central JerseySomerville, Egyesült ÁllamokNo longer taking part
  • Regional Cancer Care Associates - SpartaSparta, Egyesült ÁllamokNo longer taking part
  • Washington University in St. LouisSt Louis, Egyesült ÁllamokNo longer taking part
  • Florida Cancer Specialists - North RegionSt. Petersburg, Egyesült ÁllamokNo longer taking part
  • Toledo Clinic Cancer CenterToledo, Egyesült ÁllamokNo longer taking part
  • Texas Oncology - Northeast TexasTyler, Egyesült ÁllamokNo longer taking part
  • Clinical Research Alliance - Morton Coleman, MDWestbury, Egyesült ÁllamokNo longer taking part
  • Wake Forest Baptist Medical Center / Wake Forest UniversityWinston-Salem, Egyesült ÁllamokNo longer taking part

Trial details

Who runs it
Seagen Inc.
Trial code
NCT03646123
Record updated
2025. augusztus 28.
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.

ClinicalTrials.gov NCT03646123