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The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
Active Not-enrolling
United States, Czechia, France, Italy, Spain, United Kingdom
EXPERIMENTAL: CD30-negative Cohort
Participants with CD30 expression level \< 1%
DRUG: brentuximab vedotin
1.8 mg/kg administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycleDRUG: cyclophosphamide
750 mg/m\^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycleDRUG: doxorubicin
50 mg/m\^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycleDRUG: prednisone
100 mg daily administered orally on Days 1-5 of each cycleEXPERIMENTAL: CD30-positive Cohort
Participants with CD30 expression level ≥1% to \< 10%
DRUG: brentuximab vedotin
1.8 mg/kg administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycleDRUG: cyclophosphamide
750 mg/m\^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycleDRUG: doxorubicin
50 mg/m\^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycleDRUG: prednisone
100 mg daily administered orally on Days 1-5 of each cycleExclusion Criteria
Objective response rate (ORR) per blinded independent central review (BICR) using Revised Response Criteria for Malignant Lymphoma criteria (Cheson 2007)
ORR is defined as the proportion of participants with complete response (CR) or partial response (PR) at the completion of study treatment
From start of study treatment up to approximately 7 months
Complete response (CR) rate per BICR
CR rate is defined as the proportion of participants with CR following the completion of study treatment using Revised Response Criteria of Malignant Lymphoma (Cheson 2007).
From start of study treatment up to approximately 7 months
Progression-free survival (PFS) per BICR
Time from start of treatment to the first documented disease progression or death from any cause, whichever comes first
Up to approximately 3 years
Overall survival
Time from first dose to death due to any cause
Up to approximately 3 years
Duration of response (DOR) per BICR
Time from first occurrence of an objective response to the date of disease progression or death from any cause, whichever comes first
Approximately 3 years
ORR per BICR per modified Lugano criteria (Cheson 2014)
ORR is defined as the proportion of participants with CR or PR at the completion of study treatment
From start of study treatment up to approximately 7 months
Incidence of adverse events
An adverse event is any untoward medical occurrence in a subject or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment
From start of study treatment up to approximately 7 months
Incidence of laboratory abnormalities
To be summarized using descriptive statistics.
From start of study treatment up to approximately 7 months
82
Sponsor: Seagen Inc.
Collaborator: None
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number: