Clinical trial NCT03947255: A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma
Official title: A Phase 2, Multicenter, Single-arm Study of Retreatment With Brentuximab Vedotin in Subjects With Relapsed or Refractory Classic Hodgkin Lymphoma (cHL) or CD30-expressing Peripheral T Cell Lymphoma (PTCL)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hodgkin Lymphoma
Peripheral T Cell Lymphoma
Anaplastic Large Cell Lymphoma
Keywords: CD30-expression
sALCL
PTCL
cHL
Seattle Genetics
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will look at whether brentuximab vedotin works and is safe in the re-treatment setting. To be in this study, patients must have already received brentuximab vedotin as treatment and have cancer that progressed (got worse) after stopping treatment.

Detailed description: This is a study to determine the safety and efficacy of brentuximab vedotin in subjects with classic Hodgkin lymphoma (cHL) and systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T cell lymphoma (PTCL) who experienced complete response (CR) or partial response (PR) with a brentuximab vedotin-containing regimen and subsequently experienced disease progression or relapse.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed cHL, sALCL, or other CD30-expressing PTCL
* Previously treated with brentuximab vedotin containing regimen, with evidence of objective response, and subsequent disease progression or relapse after discontinuing treatment
* Documentation of disease relapse or progression ≥6 months after the last dose of brentuximab vedotin
* Fluorodeoxyglucose positron emission tomography- (FDG-PET) avid and bidimensional measurable disease of at least 1.5 cm in longest axis as documented by radiographic technique
* Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
* Must not be pregnant and, if of childbearing or fathering potential, must agree to use 2 effective contraception methods during study and for 6 months following last dose of study drug

Exclusion Criteria:

* Previously discontinued brentuximab vedotin due to any Grade 3 or higher toxicity
* Existing Grade 2 or higher peripheral neuropathy
* Previously refractory to treatment with brentuximab vedotin
* History of a cerebral vascular event, unstable angina, or myocardial infarction within 6 months prior to first dose
* History of another malignancy within 3 years before first dose of study drug or any evidence of residual disease from previously diagnosed malignancy
* Acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment for or prophylaxis agent against GvHD
* Active cerebral/meningeal disease
* History of progressive multifocal leukoencephalopathy (PML)
* Active uncontrolled Grade 3 (per NCI CTCAE v5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to first dose of study drug
* Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study drug, unless underlying disease has progressed on treatment

Primary outcomes:
measure: Objective Response Rate (ORR) Per BICR According to Modified Lugano Response Criteria
timeFrame: Up to 18.3 months
measure: Number of Participants With Adverse Events
timeFrame: Up to 36 months
measure: Number of Participants With Laboratory Abnormalities
timeFrame: Up to 36 months
Secondary outcomes:
measure: Duration of Response (DOR) Per BICR According to Modified Lugano Response Criteria
timeFrame: Up to 17.1 months
measure: Progression-free Survival (PFS) Per BICR According to Modified Lugano Response Criteria
timeFrame: up to 18.3 months
measure: Overall Survival (OS)
timeFrame: Up to 35.8 months
measure: Rate of Complete Response (CR) Per BICR According to Modified Lugano Response Criteria
timeFrame: Up to 18.3 months
measure: ORR Per Investigator Assessment According to Modified Lugano Response Criteria
timeFrame: Up to 18.3 months
measure: DOR Per Investigator Assessment According to Modified Lugano Response Criteria
timeFrame: Up to 17.1 months
measure: Progression-free Survival Per Investigator Assessment According to Modified Lugano Response Criteria
timeFrame: Up to 18.3 months
measure: Rate of Complete Response Per Investigator Assessment According to Modified Lugano Response Criteria
timeFrame: Up to 18.3 months
measure: ORR Per BICR According to Lugano Response Criteria
timeFrame: Up to 18.3 months
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center
state: California
city: Lafayette
country: United States
facility: SCL Health Good Samaritan Medical Center Cancer Centers of Colorado
state: Colorado
city: Pembroke Pines
country: United States
facility: Memorial Cancer Institute
state: Florida
city: Elk Grove Village
country: United States
facility: Northwest Oncology and Hematology/AMITA
state: Illinois
city: Maywood
country: United States
facility: Cardinal Bernardin Cancer Center / Loyola University Medical Center
state: Illinois
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University Hospital and Clinic
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Detroit
country: United States
facility: Karmanos Cancer Institute / Wayne State University
state: Michigan
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Florham Park
country: United States
facility: Summit Medical Group
state: New Jersey
city: Charleston
country: United States
facility: Medical University of South Carolina/Hollings Cancer Center
state: South Carolina
city: Dallas
country: United States
facility: Texas Oncology - Fort Worth
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology - Fort Worth 12th Avenue
state: Texas
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders: Fortworth
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center / University of Texas
state: Texas
city: Houston
country: United States
facility: Houston Methodist Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology - San Antonio Medical Center
state: Texas
Study officials:
affiliation: Seagen Inc.
name: Dominic Lai, MD
role: STUDY_DIRECTOR
References: