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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03646123
Registration number
NCT03646123
Ethics application status
Date submitted
22/08/2018
Date registered
24/08/2018
Date last updated
28/08/2025
Titles & IDs
Public title
Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma
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Scientific title
Multiple Part Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma Subjects
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Secondary ID [1]
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SGN35-027
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hodgkin Lymphoma
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Condition category
Condition code
Cancer
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Hodgkin's
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - brentuximab vedotin
Treatment: Drugs - doxorubicin
Treatment: Drugs - vinblastine
Treatment: Drugs - dacarbazine
Treatment: Drugs - G-CSF
Treatment: Drugs - nivolumab
Experimental: 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.
Experimental: 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.
Experimental: 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.
Treatment: Drugs: brentuximab vedotin
1.2 mg/kg by IV infusion
Treatment: Drugs: doxorubicin
25 mg/m\^2 by IV infusion
Treatment: Drugs: vinblastine
6 mg/m\^2 by IV infusion
Treatment: Drugs: dacarbazine
375 mg/m\^2 by IV infusion
Treatment: Drugs: G-CSF
Granulocyte colony stimulating factor (G-CSF) primary prophylaxis administered 24-36 hours after each dose of A+AVD
Treatment: Drugs: nivolumab
240 mg by IV infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Febrile Neutropenia (FN) Rate (Part A)
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Assessment method [1]
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The FN rate is defined as the number of participants who experience treatment-emergent FN.
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Timepoint [1]
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7.5 months
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Primary outcome [2]
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Complete Response (CR) Rate at EOT (Parts B and C)
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Assessment method [2]
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CR rate at EOT is defined as the percentage of participants with CR at EOT, according to the Lugano Classification Revised Staging System for malignant lymphoma (Cheson 2014) with the incorporation of Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (Cheson 2016), in participants with previously untreated cHL.
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Timepoint [2]
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7.8 months
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Secondary outcome [1]
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Number of Participants With Adverse Events of Clinical Interest (AECI) (Part A)
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Assessment method [1]
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An adverse event (AE) was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with the treatment. Participants with peripheral neuropathy (PN) adverse events were summarized under AECI.
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Timepoint [1]
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Approximately up to 7.5 months
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Secondary outcome [2]
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Primary Refractory Disease Rate (Part A)
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Assessment method [2]
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The primary refractory disease rate is defined as the percentage of participants with less than complete response or relapse within 3 months of EOT, according to the Lugano Classification Revised Staging System for nodal non-Hodgkin and Hodgkin lymphomas
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Timepoint [2]
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10.2 months
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Secondary outcome [3]
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Complete Response Rate (Part A)
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Assessment method [3]
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The complete response rate is defined as the percentage of participants with CR at EOT according to the Lugano Classification Revised Staging System for nodal non-Hodgkin and Hodgkin lymphomas (Cheson 2014).
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Timepoint [3]
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7.2 months
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Secondary outcome [4]
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Physician-reported Progression Free Survival (PFS) (Part A)
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Assessment method [4]
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The physician-reported PFS rate at 2 years is estimated based on Kaplan-Meier methodology. The determination of antitumor activity will be based on response assessments made according to the Lugano Classification Revised Staging System for nodal non-Hodgkin and Hodgkin lymphomas (Cheson 2014).
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Timepoint [4]
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24 months
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Secondary outcome [5]
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Number of Participants With Subsequent Anticancer Therapy Utilization (Part A)
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Assessment method [5]
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Number of participants with subsequent anticancer therapy have been reported in this outcome measure.
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Timepoint [5]
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33.8 months
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Secondary outcome [6]
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Actual Dose Intensity: Brentuximab Vedotin (Part A)
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Assessment method [6]
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Timepoint [6]
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6.5 months
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Secondary outcome [7]
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Actual Dose Intensity: Doxorubicin, Vinblastine, Dacarbazine (Part A)
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Assessment method [7]
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Timepoint [7]
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6.5 months
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Secondary outcome [8]
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Relative Dose Intensity (Part A)
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Assessment method [8]
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Timepoint [8]
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6.5 months
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Secondary outcome [9]
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Rate of Dose Reduction and Delays: Brentuximab Vedotin (Part A)
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Assessment method [9]
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Timepoint [9]
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6.5 months
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Secondary outcome [10]
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Rate of Dose Reduction and Delays: Doxorubicin (Part A)
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Assessment method [10]
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Timepoint [10]
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6.5 months
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Secondary outcome [11]
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Rate of Dose Reduction and Delays: Vinblastine (Part A)
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Assessment method [11]
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Timepoint [11]
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6.5 months
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Secondary outcome [12]
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Rate of Dose Reduction and Delays: Dacarbazine (Part A)
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Assessment method [12]
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Timepoint [12]
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6.5 months
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Secondary outcome [13]
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Incidence of Adverse Events (Parts B and C)
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Assessment method [13]
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Timepoint [13]
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8.9 months
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Secondary outcome [14]
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Incidence of Laboratory Abnormalities (Parts B and C)
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Assessment method [14]
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Laboratory values were graded according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.03). As per NCI CTCAE version 4.03 grading, Grade 1 indicated mild or asymptomatic laboratory abnormalities, Grade 2 indicated moderate laboratory abnormalities, and Grade 3 indicated severe and 4 indicated life-threatening laboratory abnormalities.
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Timepoint [14]
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8.9 months
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Secondary outcome [15]
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Overall Response Rate (ORR) at EOT (Parts B and C)
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Assessment method [15]
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ORR is defined as the percentage of participants with CR or partial response (PR) at EOT according to the Lugano Classification Revised Staging System for malignant lymphoma (Cheson 2014) with the incorporation of LYRIC (Cheson 2016) in participants with previously untreated cHL.
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Timepoint [15]
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Up to 7.8 months
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Secondary outcome [16]
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Duration of Response (DOR) at End of Study (Parts B and C)
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Assessment method [16]
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DOR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression per the Lugano Classification Revised Staging System for malignant lymphoma (Cheson 2014) with the incorporation of LYRIC (Cheson 2016) or death, whichever came first. Duration of response was only calculated for the subgroup of participants achieving a CR or PR. Participants without progression or death were censored on the date of the last radiological assessment of measured lesions. Kaplan-Meier method was used.
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Timepoint [16]
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Up to 51.1 months
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Secondary outcome [17]
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Duration of Complete Response (DOCR) (Parts B and C)
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Assessment method [17]
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DOCR was defined as the time from start of the first documentation of CR to the first documentation of tumor progression (per the Lugano Classification Revised Staging System for malignant lymphoma (Cheson 2014) with the incorporation of LYRIC (Cheson 2016) or death, whichever came first. DOCR was calculated for the subgroup of participants achieving CR. Participants without progression or death were censored on the date of the last radiological assessment of measured lesions. Kaplan-Meier method was used.
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Timepoint [17]
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Up to 51.1 months
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Secondary outcome [18]
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Event Free Survival (EFS) Rate (Parts B and C)
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Assessment method [18]
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EFS was defined as the time from the start of study treatment to the first documentation of objective tumor progression, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or progressive disease, whichever occurred first. The determination of antitumor activity will be based on objective response assessments made according to Lugano Classification Revised Staging System for malignant lymphoma (Cheson 2014) with the incorporation of LYRIC (Cheson 2016). Participants without progression or death were censored on the date of the last radiological assessment of measured lesions. EFS rate was percentage of participants with EFS.
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Timepoint [18]
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Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
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Secondary outcome [19]
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PFS Rate (Parts B and C)
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Assessment method [19]
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PFS was defined as the time from start of study treatment to first documentation of objective tumor progression or death. The determination of antitumor activity will be based on objective response assessments made according to Lugano Classification Revised Staging System for malignant lymphoma (Cheson 2014) with the incorporation of LYRIC (Cheson 2016). Participants without progression or death were censored on the date of the last radiological assessment of measured lesions. Kaplan-Meier method was used.
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Timepoint [19]
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At months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 from the start of study treatment
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Secondary outcome [20]
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Overall Survival (OS) Rate (Parts B and C)
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Assessment method [20]
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OS was defined as the time from start of study treatment to date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. Kaplan-Meier method was used.
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Timepoint [20]
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At months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 from the start of study treatment
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Eligibility
Key inclusion 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
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/01/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
23/08/2024
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Sample size
Target
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Accrual to date
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Final
255
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Recruitment in Australia
Recruitment state(s)
Othe
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]
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Ballarat Regional Integrated Cancer Care - Ballarat
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Recruitment hospital [3]
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Monash Medical Centre - Clayton
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Recruitment hospital [4]
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Epworth Healthcare - Victoria
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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3350 - Ballarat
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment postcode(s) [4]
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3002 - Victoria
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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Missouri
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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Ohio
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United States of America
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Oregon
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0
0
United States of America
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State/province [14]
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South Carolina
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0
0
United States of America
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State/province [15]
0
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Tennessee
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0
0
United States of America
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State/province [16]
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Texas
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0
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United States of America
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Utah
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United States of America
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Virginia
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United States of America
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Washington
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Czechia
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Other
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Italy
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Other
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Poland
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Other
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Country [23]
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Spain
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State/province [23]
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Other
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Seagen Inc.
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Bristol-Myers Squibb
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT03646123
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
Name
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Medical Monitor
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Address
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Seagen Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/23/NCT03646123/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/23/NCT03646123/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03646123
Download to PDF