RSH_SGNCD19A-004

RSH SGNCD19A-004-An Open Label Phase 2 Study of Denintuzumab Mafodotin (SGN-CD19A) in Combination With RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) or RCHP (Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone) Compared With RCHOP Alone as Frontline Therapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL) or Follicular Lymphoma (FL) Grade 3b

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
Phase II
NCT02855359
Cancer, All Other
Hematologic
Ying Zhuo, M.D.
Seattle Genetics Inc.
Paul Alderson
  • Kadlec Research