Non Hodgkin Lymphoma Clinical Trial
Denintuzumab Mafodotin (SGN-CD19A) Combined With RCHOP or RCHP Versus RCHOP Alone in Diffuse Large B-Cell Lymphoma or Follicular Lymphoma
Summary
This is a Phase 2 study to evaluate the combination of denintuzumab mafodotin in combination with RCHOP or RCHP compared with RCHOP alone as front-line therapy in patients with diffuse large B-cell lymphoma or follicular lymphoma Grade 3b.
Full Description
In Part A of the study, patients will be randomized 1:1 to receive denintuzumab mafodotin plus RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) or denintuzumab mafodotin plus RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) to assess the safety of these 2 combination regimens. Part B of the study is designed to evaluate the antitumor activity and safety of denintuzumab mafodotin in combination with either RCHOP or RCHP (Experimental Arm) compared with RCHOP alone (Comparator Arm).
Eligibility Criteria
Inclusion Criteria:
Treatment-naive patients with histologically confirmed systemic de novo or transformed diffuse large B-cell lymphoma (DLBCL) (from follicular or marginal zone lymphoma), or follicular lymphoma (FL) Grade 3b;
patients must have high intermediate or high risk disease
Tumor tissue available from most recent biopsy to determine cell of origin
Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease greater than 1.5cm diameter
Eastern Cooperative Oncology Group performance status ≤2
Age 18 years or older
Adequate study baseline laboratory parameters
Exclusion Criteria:
Previous history of treated indolent lymphoma
History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years
History of progressive multifocal leukoencephalopathy
Cerebral/meningeal disease related to the underlying malignancy
Patients with the following ocular conditions: corneal disorders, monocular vision (ie. best corrected visual acuity greater than or equal to 20/200 in one eye), or active ocular disorders requiring treatment
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There are 35 Locations for this study
Birmingham Alabama, 35294, United States
Jonesboro Arkansas, 72401, United States
Duarte California, 91010, United States
Fountain Valley California, 92708, United States
San Francisco California, 94115, United States
Colorado Springs Colorado, 80909, United States
Fort Collins Colorado, 80528, United States
Macon Georgia, 31201, United States
Maywood Illinois, 60153, United States
Iowa City Iowa, 52242, United States
Louisville Kentucky, 40207, United States
Mount Sterling Kentucky, 40353, United States
New Orleans Louisiana, 70122, United States
Ann Arbor Michigan, 48109, United States
Minneapolis Minnesota, 55407, United States
Hattiesburg Mississippi, 39401, United States
Kansas City Missouri, 64132, United States
Farmington New Mexico, 87401, United States
Bronx New York, 10467, United States
New York New York, 10029, United States
Durham North Carolina, 27710, United States
Wilson North Carolina, 27893, United States
Canton Ohio, 44718, United States
Cleveland Ohio, 44106, United States
Philadelphia Pennsylvania, 19107, United States
Pittsburgh Pennsylvania, 15232, United States
Charleston South Carolina, 29425, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75246, United States
Lubbock Texas, 79410, United States
Temple Texas, 76508, United States
Kennewick Washington, 99336, United States
Olympia Washington, 98502, United States
Tacoma Washington, 98405, United States
Ponce , 00716, Puerto Rico
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