The FN rate is defined as the number of participants who experience treatment-emergent FN.
Any treatment-emergent FN
Group
Value
95% CI
Part A
5
Treatment-related treatment-emergent FN
Group
Value
95% CI
Part A
5
Grade 3 or higher treatment-emergent FN
Group
Value
95% CI
Part A
5
Grade 3 or higher treatment-related treatment-emergent FN
Group
Value
95% CI
Part A
5
Complete Response (CR) Rate at EOT (Parts B and C)Primary· 7.8 months
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.
Group
Value
95% CI
Part B
88
76.3 – 94.9
Part C
92
86.0 – 95.4
Number of Participants With Adverse Events of Clinical Interest (AECI) (Part A)Secondary· Approximately up to 7.5 months
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.
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
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).
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).
Group
Value
95% CI
Part A
89.23
73.76 – 95.82
Number of Participants With Subsequent Anticancer Therapy Utilization (Part A)Secondary· 33.8 months
Number of participants with subsequent anticancer therapy have been reported in this outcome measure.
Participants with any subsequent therapy
Group
Value
95% CI
Part A
6
Consolidative radiotherapy: Radiotherapy
Group
Value
95% CI
Part A
3
Consolidative radiotherapy: Proton radiation
Group
Value
95% CI
Part A
1
Immunotherapy: Nivolumab
Group
Value
95% CI
Part A
1
Maintenance: Nivolumab
Group
Value
95% CI
Part A
1
Maintenance radiotherapy: Radiation therapy
Group
Value
95% CI
Part A
1
Systemic therapy for progressive disease: Bendamustine monotherapy
Group
Value
95% CI
Part A
1
Systemic therapy for relapsed disease: Nivolumab
Group
Value
95% CI
Part A
1
Actual Dose Intensity: Brentuximab Vedotin (Part A)Secondary· 6.5 months
Group
Value
95% CI
Part A
0.5
± 0.1
Actual Dose Intensity: Doxorubicin, Vinblastine, Dacarbazine (Part A)Secondary· 6.5 months
Rate of Dose Reduction and Delays: Brentuximab Vedotin (Part A)Secondary· 6.5 months
Participants with any dose modification
Group
Value
95% CI
Part A
29
Participants with any dose delay
Group
Value
95% CI
Part A
22
Participants with any dose delay due to AE
Group
Value
95% CI
Part A
15
Participants with any dose delay due to other reason
Group
Value
95% CI
Part A
14
Participants with any dose reduction due to AE
Group
Value
95% CI
Part A
14
Rate of Dose Reduction and Delays: Doxorubicin (Part A)Secondary· 6.5 months
Participants with any dose modification
Group
Value
95% CI
Part A
25
Participants with any dose delay
Group
Value
95% CI
Part A
23
Participants with any dose delay due to AE
Group
Value
95% CI
Part A
15
Participants with any dose delay due to other reason
Group
Value
95% CI
Part A
15
Participants with any dose reduction due to AE
Group
Value
95% CI
Part A
7
Adverse events — posted to ClinicalTrials.gov
Time frame: All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Part A
Serious: 19/40 (48%)
Deaths: 2/40
Part B
Serious: 15/57 (26%)
Deaths: 1/57
Part C
Serious: 29/154 (19%)
Deaths: 1/154
Serious adverse events (71 terms)
Reaction
System
Part A
Part B
Part C
Pyrexia
General disorders
—
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
—
Pneumonia
Infections and infestations
—
—
—
Pneumonitis
Respiratory, thoracic and mediastinal disorders
—
—
—
Abdominal pain
Gastrointestinal disorders
—
—
—
Nausea
Gastrointestinal disorders
—
—
—
Vomiting
Gastrointestinal disorders
—
—
—
Pain
General disorders
—
—
—
COVID-19 pneumonia
Infections and infestations
—
—
—
Pneumocystis jirovecii pneumonia
Infections and infestations
—
—
—
Sepsis
Infections and infestations
—
—
—
Alanine aminotransferase increased
Investigations
—
—
—
Peripheral sensory neuropathy
Nervous system disorders
—
—
—
Acute kidney injury
Renal and urinary disorders
—
—
—
Hypotension
Vascular disorders
—
—
—
Anaemia
Blood and lymphatic system disorders
—
—
—
Neutropenia
Blood and lymphatic system disorders
—
—
—
Acute left ventricular failure
Cardiac disorders
—
—
—
Acute myocardial infarction
Cardiac disorders
—
—
—
Cardiac arrest
Cardiac disorders
—
—
—
Cardiac failure congestive
Cardiac disorders
—
—
—
Pericardial effusion
Cardiac disorders
—
—
—
Hypophysitis
Endocrine disorders
—
—
—
Abdominal pain upper
Gastrointestinal disorders
—
—
—
Faecaloma
Gastrointestinal disorders
—
—
—
Other adverse events (416 terms — click to expand)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05244473 — A Safety Study of Brentuximab Vedotin in Participants With HIV
· Phase 1
· withdrawn
NCT04609566 — Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors
· Phase 2
· completed
NCT04569032 — A Study of Brentuximab Vedotin and CHP in Frontline Treatment of PTCL With Less Than 10% CD30 Expression
· Phase 2
· completed
NCT04254107 — A Safety Study of SEA-TGT (SGN-TGT) in Advanced Cancer
· Phase 1
· terminated
NCT03947255 — A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral
· Phase 2
· terminated
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Seagen Inc.
Last refreshed: 28 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03646123.