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

Stopped early · Phase 2

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

In brief

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.

Key facts

Study ID

NCT03947255

Run by

Seagen Inc.

People needed

12

Starts

2019-10-28

Expected to finish

2022-11-06

Last updated by the study team

2023-10-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.