Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma
NCT ID: NCT03646123
Last Updated: 2025-08-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
255 participants
INTERVENTIONAL
2019-01-28
2024-08-23
Brief Summary
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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.
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Detailed Description
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Part A of the study is designed to evaluate the incidence of febrile neutropenia, efficacy, and dose intensity in participants with advanced stage classical Hodgkin lymphoma (cHL) receiving granulocyte colony stimulating factor primary prophylaxis (G-PP) administration during treatment with frontline A+AVD. In Part A, participants will be treated with granulocyte colony stimulating factor (G-CSF) following every dose of A+AVD for 6 cycles of treatment. Participants will be treated using institutional standard of care practices for the majority of treatment decisions.
Part B is designed to evaluate the combination of brentuximab vedotin, nivolumab, doxorubicin, and dacarbazine (AN+AD) as frontline treatment in participants with advanced cHL. In Part B, participants will be given AN+AD combination for 6 cycles of treatment. This part of the trial will look at whether this combination of drugs is effective and tolerable in participants with Stage II with bulky mediastinal disease and Stage III or IV cHL.
Part C is designed to evaluate AN+AD as frontline treatment in participants with early stage cHL. In Part C, participants will be given AN+AD combination for 4 cycles of treatment. This part of the trial will look at whether this combination of drugs is effective and tolerable in participants with Stage I or II cHL with non-bulky mediastinal disease.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part A: A+AVD
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
1.2 mg/kg by IV infusion
doxorubicin
25 mg/m\^2 by IV infusion
vinblastine
6 mg/m\^2 by IV infusion
dacarbazine
375 mg/m\^2 by IV infusion
G-CSF
Granulocyte colony stimulating factor (G-CSF) primary prophylaxis administered 24-36 hours after each dose of A+AVD
Part B: AN+AD
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
1.2 mg/kg by IV infusion
doxorubicin
25 mg/m\^2 by IV infusion
dacarbazine
375 mg/m\^2 by IV infusion
nivolumab
240 mg by IV infusion
Part C: AN+AD
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.
brentuximab vedotin
1.2 mg/kg by IV infusion
doxorubicin
25 mg/m\^2 by IV infusion
dacarbazine
375 mg/m\^2 by IV infusion
nivolumab
240 mg by IV infusion
Interventions
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brentuximab vedotin
1.2 mg/kg by IV infusion
doxorubicin
25 mg/m\^2 by IV infusion
vinblastine
6 mg/m\^2 by IV infusion
dacarbazine
375 mg/m\^2 by IV infusion
G-CSF
Granulocyte colony stimulating factor (G-CSF) primary prophylaxis administered 24-36 hours after each dose of A+AVD
nivolumab
240 mg by IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Seagen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Seagen Inc.
Locations
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Los Angeles Cancer Network / Compassionate Care Research Group
Fountain Valley, California, United States
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, United States
University of Colorado Health Memorial Hospital
Colorado Springs, Colorado, United States
Cancer Centers of Colorado - Denver
Denver, Colorado, United States
Poudre Valley Health System (PVHS)
Fort Collins, Colorado, United States
SCL Health - St. Mary's Hospital & Medical Center
Grand Junction, Colorado, United States
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States
Florida Cancer Specialists - North Region
St. Petersburg, Florida, United States
Cardinal Bernardin Cancer Center / Loyola University Medical Center
Maywood, Illinois, United States
Illinois Cancer Specialists
Niles, Illinois, United States
Illinois Cancer Care
Peoria, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Minnesota Oncology Hematology P.A.
Edina, Minnesota, United States
Washington University in St Louis
St Louis, Missouri, United States
New Jersey Hematology Oncology Associates, LLC
Brick, New Jersey, United States
Regional Cancer Care Associates - Freehold
Freehold, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Regional Cancer Care Associates - Howell
Howell Township, New Jersey, United States
Morristown Medical Center/ Carol G. Simon Cancer Center
Morristown, New Jersey, United States
Regional Cancer Care Associates - Mount Holly
Mount Holly, New Jersey, United States
Regional Cancer Care Associates - Central Jersey
Somerville, New Jersey, United States
Regional Cancer Care Associates - Sparta
Sparta, New Jersey, United States
New York Oncology Hematology, P.C.
Albany, New York, United States
CareMount Medical Group
Mount Kisco, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Clinical Research Alliance - Abraham Mittelman, MD, LLC
Purchase, New York, United States
Clinical Research Alliance - Morton Coleman, MD
Westbury, New York, United States
Wake Forest Baptist Medical Center / Wake Forest University
Winston-Salem, North Carolina, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic, The
Cleveland, Ohio, United States
Toledo Clinic Cancer Center
Toledo, Ohio, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Medical University of South Carolina/Hollings Cancer Center
Charleston, South Carolina, United States
University of Tennessee
Knoxville, Tennessee, United States
Tennessee Oncology-Nashville/Sarah Cannon Research Institute
Nashville, Tennessee, United States
Texas Oncology - Austin Midtown
Austin, Texas, United States
Texas Oncology - Medical City Dallas
Dallas, Texas, United States
Texas Oncology - Flower Mound
Flower Mound, Texas, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Texas Oncology - Fort Worth 12th Avenue
Fort Worth, Texas, United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States
Texas Oncology - San Antonio Medical Center
San Antonio, Texas, United States
Texas Oncology - Northeast Texas
Tyler, Texas, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care
Salem, Virginia, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States
Vista Oncology Inc PS
Olympia, Washington, United States
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, United States
Royal Adelaide Hospital
Adelaide, Other, Australia
Ballarat Regional Integrated Cancer Care
Ballarat, Other, Australia
Monash Medical Centre
Clayton, Other, Australia
Epworth Healthcare
Victoria, Other, Australia
Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie
Hradec Králové, Other, Czechia
Fakultni Nemocnice Kralovske Vinohrady
Prague, Other, Czechia
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, Other, Italy
IRCSS Policlinico San Matteo
Pavia, Other, Italy
Azienda Ospedaliera Universitaria Senese
Siena, Other, Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino
Torino, Other, Italy
Pratia MCM Krakow
Krakow, Other, Poland
Hospital del Mar
Barcelona, Other, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Other, Spain
Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
Barcelona, Other, Spain
Hospital Universitario de Girona Doctor Josep Trueta
Girona, Other, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Other, Spain
Hospital Universitario 12 de Octubre
Madrid, Other, Spain
Hospital Puerta de Hierro Majadahonda
Majadahonda, Other, Spain
Hospital Universitario Central de Asturias
Oviedo, Other, Spain
Hospital Clinico Universitario de Salamanca
Salamanca, Other, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Other, Spain
Countries
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References
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Lee HJ, Ramchandren R, Friedman J, Melear J, Flinn IW, Burke JM, Linhares Y, Gonzales P, Peterson M, Raval M, Chintapatla R, Feldman TA, Yimer H, Islas-Ohlmayer M, Patel A, Metheny L, Dean A, Rana V, Gandhi MD, Renshaw J, Ho L, Fanale MA, Guo W, Yasenchak CA. Brentuximab vedotin, nivolumab, doxorubicin, and dacarbazine for advanced-stage classical Hodgkin lymphoma. Blood. 2025 Jan 16;145(3):290-299. doi: 10.1182/blood.2024024681.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SGN35-027
Identifier Type: -
Identifier Source: org_study_id
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