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

NCT03947255 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: SGN35-028
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 19

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.

Conditions

Hodgkin Lymphoma; Peripheral T Cell Lymphoma; Anaplastic Large Cell Lymphoma

Keywords

CD30-expression; sALCL; PTCL; cHL; Seattle Genetics

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (9)

• Duration of Response (DOR) Per BICR According to Modified Lugano Response Criteria

  Up to 17.1 months

• Progression-free Survival (PFS) Per BICR According to Modified Lugano Response Criteria

  up to 18.3 months

• Overall Survival (OS)

  Up to 35.8 months

• Rate of Complete Response (CR) Per BICR According to Modified Lugano Response Criteria

  Up to 18.3 months

• ORR Per Investigator Assessment According to Modified Lugano Response Criteria

  Up to 18.3 months

Study Arms (1)

Brentuximab vedotin

EXPERIMENTAL

Drug: brentuximab vedotin

Interventions

brentuximab vedotin DRUG

1.8 mg/kg given intravenously (IV)

Also known as: ADCETRIS, SGN-35

Brentuximab vedotin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seagen Inc.: lead

Study Sites (19)

Pacific Cancer Medical Center

Anaheim, California, 92801, United States

Location

SCL Health Good Samaritan Medical Center Cancer Centers of Colorado

Lafayette, Colorado, 80026, United States

Location

Memorial Cancer Institute

Pembroke Pines, Florida, 33028, United States

Location

Northwest Oncology and Hematology/AMITA

Elk Grove Village, Illinois, 60007, United States

Location

Cardinal Bernardin Cancer Center / Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40207, United States

Location

Tulane University Hospital and Clinic

New Orleans, Louisiana, 70112, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Karmanos Cancer Institute / Wayne State University

Detroit, Michigan, 48201, United States

Location

Saint Louis University

St Louis, Missouri, 63103, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

Summit Medical Group

Florham Park, New Jersey, 07932, United States

Location

Medical University of South Carolina/Hollings Cancer Center

Charleston, South Carolina, 29425, United States

Location

Texas Oncology - Fort Worth

Dallas, Texas, 75246, United States

Location

Texas Oncology - Fort Worth 12th Avenue

Fort Worth, Texas, 76104, United States

Location

The Center for Cancer and Blood Disorders: Fortworth

Fort Worth, Texas, 76104, United States

Location

MD Anderson Cancer Center / University of Texas

Houston, Texas, 77030-4095, United States

Location

Houston Methodist Cancer Center

Houston, Texas, 77030, United States

Location

Texas Oncology - San Antonio Medical Center

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

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

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Seagen Inc.

medinfo@seagen.com

(855) 473-2436

Study Officials

• Dominic Lai, MD

  Seagen Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 13, 2019
• Study Start: October 28, 2019
• Primary Completion: November 6, 2022
• Study Completion: November 6, 2022
• Last Updated: October 13, 2023
• Results First Posted: October 13, 2023

Record last verified: 2023-10

Locations

US (19)