Non Hodgkin Lymphoma Clinical Trial
A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)
Summary
This trial will study brentuximab vedotin to find out whether it is an effective treatment for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). Participants in this study will be older or will have other conditions that make them unable to have standard chemotherapy treatment. The study will look at brentuximab vedotin alone and combined with other drugs.
Full Description
This study is designed to evaluate the efficacy and tolerability of brentuximab vedotin as monotherapy and in combination with other agents as frontline therapy. There are 6 parts of the study. The population to be studied includes treatment-naïve patients with classical Hodgkin lymphoma (HL) or treatment-naïve patients with CD30-expressing peripheral T-cell lymphoma (PTCL).
Eligibility Criteria
Inclusion Criteria:
Parts A, B, C, and D: 60 years of age or older
Treatment-naive patients with histopathological diagnosis of classical Hodgkin lymphoma (Parts A, B, C, D, and E)
Treatment-naive patients with CD30-expressing PTCL (Part F)
Ineligible for or have declined initial conventional combination chemotherapy for HL (Parts A, B, C, and D)
Unsuitable or unfit for initial conventional combination chemotherapy for HL (Part E) or CD30-expressing PTCL due to the presence of comorbidity-factors, as documented by:
A CIRS score of 10 or greater
Requiring assistance with or dependence on other for any instrumental activities of daily living (IADLs)
Measurable disease of at least 1.5 cm as documented by radiographic technique
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3 (Parts, A, B, C, E, and F) or less than or equal to 2 (Part D)
Exclusion Criteria:
Symptomatic neurologic disease compromising IADLs or requiring medication
History of progressive multifocal leukoencephalopathy
Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of brentuximab vedotin
Concurrent use of other investigational agents
Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug
History of another malignancy within 1 year before first dose of study drug (Parts E and F only)
Part D only:
Received any prior immune-oncology therapy
History of known or suspected autoimmune disease
Prior allogeneic stem cell transplant
History of cerebral vascular event within 6 months of first dose of study drug
Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicology
Known history of pancreatitis
Parts D, E, and F only:
Known cerebral/meningeal disease related to the underlying malignancy
Systemic treatment with corticosteroids or other immunosuppressive medications within 1 week of enrollment
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There are 53 Locations for this study
Birmingham Alabama, 35249, United States
Mobile Alabama, 36604, United States
Anchorage Alaska, 99503, United States
Gilbert Arizona, 85234, United States
Tucson Arizona, 85710, United States
Tucson Arizona, 85724, United States
Springdale Arkansas, J. Th, United States
Burbank California, 91505, United States
Duarte California, 91010, United States
Pomona California, 91767, United States
Aurora Colorado, 80012, United States
Trinity Florida, 34655, United States
Columbus Georgia, 31904, United States
Sandy Springs Georgia, 30341, United States
Chicago Illinois, 60612, United States
Niles Illinois, 60714, United States
Bethesda Maryland, 20817, United States
Detroit Michigan, 48201, United States
Minneapolis Minnesota, 55404, United States
Omaha Nebraska, 68130, United States
Las Vegas Nevada, 89169, United States
Morristown New Jersey, 07960, United States
New Brunswick New Jersey, 08903, United States
Albany New York, 12208, United States
New York New York, 10032, United States
Rochester New York, 14642, United States
Cincinnati Ohio, 45242, United States
Columbus Ohio, 43210, United States
Eugene Oregon, 97401, United States
Tigard Oregon, 97223, United States
Greenville South Carolina, 29615, United States
Arlington Texas, 76012, United States
Bedford Texas, 76022, United States
Dallas Texas, 75231, United States
Denton Texas, Kurku, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Longview Texas, 75601, United States
McAllen Texas, 78503, United States
Round Rock Texas, 78665, United States
Fairfax Virginia, 22031, United States
Richmond Virginia, 23298, United States
Salem Virginia, 24153, United States
Winchester Virginia, 22601, United States
Seattle Washington, 98101, United States
Seattle Washington, 98104, United States
Wenatchee Washington, 98821, United States
Madison Wisconsin, 53792, United States
Edmonton Alberta, T6G 1, Canada
London Ontario, N6A 5, Canada
Montreal Quebec, H1T 2, Canada
Montreal Quebec, H3T 1, Canada
Montreal Quebec, H4A 3, Canada
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