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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03947255
Other study ID # SGN35-028
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date October 28, 2019
Est. completion date November 6, 2022

Study information

Verified date October 2023
Source Seagen Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Terminated
Enrollment 12
Est. completion date November 6, 2022
Est. primary completion date November 6, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Drug:
brentuximab vedotin
1.8 mg/kg given intravenously (IV)

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Seagen Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Response Rate (ORR) Per BICR According to Modified Lugano Response Criteria 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 Up to 18.3 months
Primary Number of Participants With Adverse Events 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. Up to 36 months
Primary Number of Participants With Laboratory Abnormalities Laboratory data was summarized by the worst post-baseline grade, by NCI CTCAE v5.0 or higher for each parameter. Up to 36 months
Secondary Duration of Response (DOR) Per BICR According to Modified Lugano Response Criteria 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. Up to 17.1 months
Secondary Progression-free Survival (PFS) Per BICR According to Modified Lugano Response Criteria 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. up to 18.3 months
Secondary Overall Survival (OS) OS is defined as the time from date of enrollment to date of death due to any cause. Up to 35.8 months
Secondary Rate of Complete Response (CR) Per BICR According to Modified Lugano Response Criteria CR rate is defined as the percentage of participants with CR according to the modified Lugano Criteria for Response Assessment (Cheson 2014) Up to 18.3 months
Secondary ORR Per Investigator Assessment According to Modified Lugano Response Criteria 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 Up to 18.3 months
Secondary DOR Per Investigator Assessment According to Modified Lugano Response Criteria 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. Up to 17.1 months
Secondary Progression-free Survival Per Investigator Assessment According to Modified Lugano Response Criteria 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. Up to 18.3 months
Secondary Rate of Complete Response Per Investigator Assessment According to Modified Lugano Response Criteria CR rate is defined as the percentage of participants with CR according to the Modified Lugano Criteria for Response Assessment (Cheson 2014). Up to 18.3 months
Secondary ORR Per BICR According to Lugano Response Criteria ORR is defined as the percentage of participants with CR or PR, assessed according to Lugano Criteria for Response Assessment (Cheson 2014) Up to 18.3 months
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