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

Hodgkin Lymphoma Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03947255
• Other study ID #: SGN35-028
• Status: Terminated
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Anaplastic Large Cell Lymphoma
• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma
• Lymphoma, Large-Cell, Anaplastic
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T Cell Lymphoma

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