Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
18/06/2024
Titles & IDs
Public title
Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma
Query!
Scientific title
Multiple Part Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma Subjects
Query!
Secondary ID [1]
0
0
SGN35-027
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Hodgkin Lymphoma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Query!
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Query!
Cancer
0
0
0
0
Query!
Hodgkin's
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Febrile Neutropenia (FN) Rate (Part A)
Query!
Assessment method [1]
0
0
The FN rate is defined as the number of participants who experience treatment-emergent FN.
Query!
Timepoint [1]
0
0
7.5 months
Query!
Primary outcome [2]
0
0
Complete Response (CR) Rate (Parts B and C)
Query!
Assessment method [2]
0
0
CR rate at EOT is defined as the percentage of subjects with CR at EOT, according to the Lugano Classification Revised Staging System for malignant lymphoma (Cheson 2014) with the incorporation of LYRIC (Cheson 2016), in subjects with previously untreated cHL.
Query!
Timepoint [2]
0
0
7.8 months
Query!
Secondary outcome [1]
0
0
Primary Refractory Disease Rate (Part A)
Query!
Assessment method [1]
0
0
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
Query!
Timepoint [1]
0
0
10.2 months
Query!
Secondary outcome [2]
0
0
Complete Response Rate (Part A)
Query!
Assessment method [2]
0
0
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).
Query!
Timepoint [2]
0
0
7.2 months
Query!
Secondary outcome [3]
0
0
Physician-reported Progression Free Survival (PFS) (Part A)
Query!
Assessment method [3]
0
0
The physician-reported PFS rate at 2 years is estimated based on Kaplan-Meier methodology.
Query!
Timepoint [3]
0
0
24 months
Query!
Secondary outcome [4]
0
0
Subsequent Anticancer Therapy Utilization Rate (Part A)
Query!
Assessment method [4]
0
0
Number of participants with subsequent anticancer therapy
Query!
Timepoint [4]
0
0
33.8 months
Query!
Secondary outcome [5]
0
0
Actual Dose Intensity: Brentuximab Vedotin (Part A)
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
6.5 months
Query!
Secondary outcome [6]
0
0
Actual Dose Intensity: Doxorubicin, Vinblastine, Dacarbazine (Part A)
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
6.5 months
Query!
Secondary outcome [7]
0
0
Relative Dose Intensity (Part A)
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
6.5 months
Query!
Secondary outcome [8]
0
0
Rate of Dose Reduction and Delays: Brentuximab Vedotin (Part A)
Query!
Assessment method [8]
0
0
Query!
Timepoint [8]
0
0
6.5 months
Query!
Secondary outcome [9]
0
0
Rate of Dose Reduction and Delays: Doxorubicin (Part A)
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
6.5 months
Query!
Secondary outcome [10]
0
0
Rate of Dose Reduction and Delays: Vinblastine (Part A)
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
6.5 months
Query!
Secondary outcome [11]
0
0
Rate of Dose Reduction and Delays: Dacarbazine (Part A)
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
6.5 months
Query!
Secondary outcome [12]
0
0
Incidence of Adverse Events (Parts B and C)
Query!
Assessment method [12]
0
0
Query!
Timepoint [12]
0
0
8.9 months
Query!
Secondary outcome [13]
0
0
Incidence of Laboratory Abnormalities (Parts B and C)
Query!
Assessment method [13]
0
0
Laboratory values were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.03).
Query!
Timepoint [13]
0
0
8.9 months
Query!
Secondary outcome [14]
0
0
Overall Response Rate (ORR) at EOT (Parts B and C)
Query!
Assessment method [14]
0
0
ORR is defined as the proportion 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 subjects with previously untreated cHL.
Query!
Timepoint [14]
0
0
7.8 months
Query!
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
Query!
Minimum age
12
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
28/01/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
7/06/2026
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
255
Query!
Recruitment in Australia
Recruitment state(s)
Othe
Query!
Recruitment hospital [1]
0
0
Royal Adelaide Hospital - Adelaide
Query!
Recruitment hospital [2]
0
0
Ballarat Regional Integrated Cancer Care - Ballarat
Query!
Recruitment hospital [3]
0
0
Monash Medical Centre - Clayton
Query!
Recruitment hospital [4]
0
0
Epworth Healthcare - Victoria
Query!
Recruitment postcode(s) [1]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [2]
0
0
3350 - Ballarat
Query!
Recruitment postcode(s) [3]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [4]
0
0
3002 - Victoria
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Illinois
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Massachusetts
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Michigan
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Minnesota
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Missouri
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
New Jersey
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
New York
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
North Carolina
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Ohio
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Oregon
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
South Carolina
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Tennessee
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Texas
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Utah
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Virginia
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Washington
Query!
Country [20]
0
0
Czechia
Query!
State/province [20]
0
0
Other
Query!
Country [21]
0
0
Italy
Query!
State/province [21]
0
0
Other
Query!
Country [22]
0
0
Poland
Query!
State/province [22]
0
0
Other
Query!
Country [23]
0
0
Spain
Query!
State/province [23]
0
0
Other
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Seagen Inc.
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
Bristol-Myers Squibb
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03646123
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Medical Monitor
Query!
Address
0
0
Seagen Inc.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT03646123
Download to PDF