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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
5/11/2024

Titles & IDs
Public title
Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma
Scientific title
Multiple Part Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma Subjects
Secondary ID [1] 0 0
SGN35-027
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hodgkin Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Hodgkin's

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Febrile Neutropenia (FN) Rate (Part A)
Timepoint [1] 0 0
7.5 months
Primary outcome [2] 0 0
Complete Response (CR) Rate (Parts B and C)
Timepoint [2] 0 0
7.8 months
Secondary outcome [1] 0 0
Primary Refractory Disease Rate (Part A)
Timepoint [1] 0 0
10.2 months
Secondary outcome [2] 0 0
Complete Response Rate (Part A)
Timepoint [2] 0 0
7.2 months
Secondary outcome [3] 0 0
Physician-reported Progression Free Survival (PFS) (Part A)
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
Subsequent Anticancer Therapy Utilization Rate (Part A)
Timepoint [4] 0 0
33.8 months
Secondary outcome [5] 0 0
Actual Dose Intensity: Brentuximab Vedotin (Part A)
Timepoint [5] 0 0
6.5 months
Secondary outcome [6] 0 0
Actual Dose Intensity: Doxorubicin, Vinblastine, Dacarbazine (Part A)
Timepoint [6] 0 0
6.5 months
Secondary outcome [7] 0 0
Relative Dose Intensity (Part A)
Timepoint [7] 0 0
6.5 months
Secondary outcome [8] 0 0
Rate of Dose Reduction and Delays: Brentuximab Vedotin (Part A)
Timepoint [8] 0 0
6.5 months
Secondary outcome [9] 0 0
Rate of Dose Reduction and Delays: Doxorubicin (Part A)
Timepoint [9] 0 0
6.5 months
Secondary outcome [10] 0 0
Rate of Dose Reduction and Delays: Vinblastine (Part A)
Timepoint [10] 0 0
6.5 months
Secondary outcome [11] 0 0
Rate of Dose Reduction and Delays: Dacarbazine (Part A)
Timepoint [11] 0 0
6.5 months
Secondary outcome [12] 0 0
Incidence of Adverse Events (Parts B and C)
Timepoint [12] 0 0
8.9 months
Secondary outcome [13] 0 0
Incidence of Laboratory Abnormalities (Parts B and C)
Timepoint [13] 0 0
8.9 months
Secondary outcome [14] 0 0
Overall Response Rate (ORR) at EOT (Parts B and C)
Timepoint [14] 0 0
7.8 months

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
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/01/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/08/2024
Sample size
Target
Accrual to date
Final
255
Recruitment in Australia
Recruitment state(s)
Othe
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Ballarat Regional Integrated Cancer Care - Ballarat
Recruitment hospital [3] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [4] 0 0
Epworth Healthcare - Victoria
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3350 - Ballarat
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3002 - Victoria
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Utah
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
Czechia
State/province [20] 0 0
Other
Country [21] 0 0
Italy
State/province [21] 0 0
Other
Country [22] 0 0
Poland
State/province [22] 0 0
Other
Country [23] 0 0
Spain
State/province [23] 0 0
Other

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Seagen Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Bristol-Myers Squibb
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Seagen Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03646123