A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma

Phase 2

Terminated

Conditions: Hodgkin Lymphoma
Anaplastic Large Cell Lymphoma
Peripheral T Cell Lymphoma

Interventions: Drug: brentuximab vedotin

Registration Number: NCT03947255

Lead Sponsor: Seagen Inc.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 12

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Brentuximab vedotin	brentuximab vedotin	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Laboratory Abnormalities	Up to 36 months	Laboratory data was summarized by the worst post-baseline grade, by NCI CTCAE v5.0 or higher for each parameter.
Objective Response Rate (ORR) Per BICR According to Modified Lugano Response Criteria	Up to 18.3 months	Objective Response Rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) according to the modified Lugano Criteria for Response Assessment (Cheson 2014) based on BICR
Number of Participants With Adverse Events	Up to 36 months	An AE is any untoward medical occurrence in a patient or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Treatment emergent AEs (TEAEs) are defined as events that are new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment.

Secondary Outcome Measures

Name	Time	Method
Duration of Response (DOR) Per BICR According to Modified Lugano Response Criteria	Up to 17.1 months	Duration of response is defined as the time from start of the first documentation of objective tumor response (CR or PR), according to the Modified Lugano Criteria for Response Assessment (Cheson 2007), to the first documentation of objective tumor progression or to death due to any cause, whichever comes first.
Overall Survival (OS)	Up to 35.8 months	OS is defined as the time from date of enrollment to date of death due to any cause.
ORR Per Investigator Assessment According to Modified Lugano Response Criteria	Up to 18.3 months	Objective Response Rate (ORR) is defined as the percentage of participants with CR or PR according to the modified Lugano Criteria for Response Assessment (Cheson 2014) based on investigator assessment
DOR Per Investigator Assessment According to Modified Lugano Response Criteria	Up to 17.1 months	Duration of response is defined as the time from start of the first documentation of objective tumor response (CR or PR), according to the Modified Lugano Criteria for Response Assessment (Cheson 2007), to the first documentation of objective tumor progression or to death due to any cause, whichever comes first.
Progression-free Survival Per Investigator Assessment According to Modified Lugano Response Criteria	Up to 18.3 months	PFS is defined as the time from start of study treatment to first documentation of objective tumor progression according to the Modified Lugano Criteria for Response Assessment (Cheson 2007) or to death due to any cause, whichever comes first.
ORR Per BICR According to Lugano Response Criteria	Up to 18.3 months	ORR is defined as the percentage of participants with CR or PR, assessed according to Lugano Criteria for Response Assessment (Cheson 2014)
Rate of Complete Response Per Investigator Assessment According to Modified Lugano Response Criteria	Up to 18.3 months	CR rate is defined as the percentage of participants with CR according to the Modified Lugano Criteria for Response Assessment (Cheson 2014).
Progression-free Survival (PFS) Per BICR According to Modified Lugano Response Criteria	up to 18.3 months	PFS is defined as the time from start of study treatment to first documentation of objective tumor progression according to the Modified Lugano Criteria for Response Assessment (Cheson 2007) or to death due to any cause, whichever comes first.
Rate of Complete Response (CR) Per BICR According to Modified Lugano Response Criteria	Up to 18.3 months	CR rate is defined as the percentage of participants with CR according to the modified Lugano Criteria for Response Assessment (Cheson 2014)

Trial Locations

Locations (19): Houston Methodist Cancer Center
🇺🇸
Houston, Texas, United States
SCL Health Good Samaritan Medical Center Cancer Centers of Colorado
🇺🇸
Lafayette, Colorado, United States
Summit Medical Group
🇺🇸
Florham Park, New Jersey, United States
Comprehensive Cancer Centers of Nevada
🇺🇸
Las Vegas, Nevada, United States
Medical University of South Carolina/Hollings Cancer Center
🇺🇸
Charleston, South Carolina, United States
MD Anderson Cancer Center / University of Texas
🇺🇸
Houston, Texas, United States
The Center for Cancer and Blood Disorders: Fortworth
🇺🇸
Fort Worth, Texas, United States
Karmanos Cancer Institute / Wayne State University
🇺🇸
Detroit, Michigan, United States
Texas Oncology - San Antonio Medical Center
🇺🇸
San Antonio, Texas, United States
Pacific Cancer Medical Center
🇺🇸
Anaheim, California, United States
Memorial Cancer Institute
🇺🇸
Pembroke Pines, Florida, United States
Tulane University Hospital and Clinic
🇺🇸
New Orleans, Louisiana, United States
Northwest Oncology and Hematology/AMITA
🇺🇸
Elk Grove Village, Illinois, United States
Norton Cancer Institute
🇺🇸
Louisville, Kentucky, United States
Cardinal Bernardin Cancer Center / Loyola University Medical Center
🇺🇸
Maywood, Illinois, United States
University of Maryland
🇺🇸
Baltimore, Maryland, United States
Texas Oncology - Fort Worth
🇺🇸
Dallas, Texas, United States
Texas Oncology - Fort Worth 12th Avenue
🇺🇸
Fort Worth, Texas, United States
Saint Louis University
🇺🇸
Saint Louis, Missouri, United States