Study of Rituximab and Bendamustine With or Without Brentuximab Vedotin for CD30 Positive Diffuse Large B-cell Lymphoma

Stopped early · Phase 2

Conditions studied: Diffuse Large B-cell Lymphoma Refractory, Follicular B-cell Non-Hodgkin's Lymphoma

In brief

This is a randomized, open-label, multicenter, Phase 2 clinical trial designed to evaluate the efficacy and safety of brentuximab vedotin in combination with rituximab and bendamustine for the treatment of patients with relapsed or refractory CD30-positive diffuse large B-cell lymphoma (DLBCL) after failure of second-line salvage therapy or as second-line treatment in patients ineligible for autologous stem cell transplant (ASCT).

Key facts

Study ID

NCT02594163

Run by

Seagen Inc.

People needed

25

Starts

2015-10-01

Expected to finish

2017-09-01

Last updated by the study team

2018-10-16

Who can join

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

You may qualify if…

• Patients with confirmed CD30-positive DLBCL or grade 3b follicular non-Hodgkin lymphoma (NHL).
• Patients must have relapsed or refractory disease following:
• second-line or greater salvage systemic therapy, or
• frontline cytotoxic systemic therapy, for patients who are ineligible for stem cell transplant (SCT).
• Age 18 years and older.
• Fluorodeoxyglucose (FDG)-avid disease by positron emission tomography (PET).
• An Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
• Acceptable blood test results.
• Females of childbearing potential must have a negative pregnancy test result within 7 days prior to the first dose of study drug.
• Females of childbearing potential and males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 6 months following the last dose of brentuximab vedotin or 12 months following the last dose of rituximab, whichever is later.
• Patients must provide written informed consent.

You may not qualify if…

• History of another invasive malignancy that has not been in remission for at least 1 year. (Exceptions are nonmelanoma skin cancer, curatively treated localized prostate cancer, ductal carcinoma, and cervical carcinoma or a squamous intraepithelial lesion on PAP smear).
• History of progressive multifocal leukoencephalopathy (PML).
• Cerebral/meningeal disease related to the underlying malignancy, unless definitively treated.
• Viral, bacterial, or fungal infection within 2 weeks prior to the first dose of treatment.
• Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study drug.
• Females who are pregnant or breastfeeding.
• Known allergy to any study drug or ingredient contained in the drug formulation of any of the study drugs.
• Known to be positive for hepatitis B. Known to have active hepatitis C infection or on antiviral therapy for hepatitis C within the last 6 months.
• Known to be positive for human immunodeficiency virus (HIV).
• Patients with previous allogeneic stem cell transplant.
• Previous treatment with brentuximab vedotin or bendamustine.
• Intolerable toxicity to prior rituximab therapy.
• Current therapy with other investigational agents.
• Lung disease unrelated to underlying malignancy.
• History of a stroke or transient ischemic attack, unstable angina, myocardial infarction, or cardiac symptoms within 6 months prior to the first dose of treatment.
• Congestive heart failure.
• Significant peripheral sensory or motor neuropathy at the start of the study.

Where it is running

• City of Hope — Duarte, California, United States
• Sansum Clinic - West Pueblo — Santa Barbara, California, United States
• Good Samaritan Hospital — Torrance, California, United States
• The Oncology Institute of Hope and Innovation — Whittier, California, United States
• Rocky Mountain Cancer Center — Aurora, Colorado, United States
• Kaiser Permanente Oncology — Lonetree, Colorado, United States
• Illinois Cancer Specialists — Niles, Illinois, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Saint Louis University Cancer Center — St Louis, Missouri, United States
• Saint Francis Cancer Treatment Center — Grand Island, Nebraska, United States
• Hematology and Oncology Associates of Northern New Jersey, P.A. — Morristown, New Jersey, United States
• Willamette Valley Cancer Institute and Research Center — Springfield, Oregon, United States
• Bon Secours Saint Francis Hospital — Greenville, South Carolina, United States
• Greenville Health System Institutional Review Board — Greenville, South Carolina, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• Texas Oncology - Flower Mound — Denton, Texas, United States
• Virginia Oncology Associates — Norfolk, Virginia, United States
• Oncology and Hematology Associates of Southwest Virginia, Inc. — Roanoke, Virginia, United States
• Virginia Mason Clinical Research — Seattle, Washington, United States
• UW Cancer Center at ProHealth Care — Waukesha, Wisconsin, United States
• FN Brno — Brno, Czechia
• Fakultni Nemocnice Hradec Kralove — Hradec Králové, Czechia
• Fakultní nemocnice Královské Vinohrady — Prague, Czechia

Full record on ClinicalTrials.gov

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