Treatment Study of Denintuzumab Mafodotin (SGN-CD19A) Plus RICE Versus RICE Alone for Diffuse Large B-Cell Lymphoma

Inclusion Criteria:

- Pathologically confirmed diagnosis of relapsed or refractory diffuse large B-cell
lymphoma (DLBCL; including de novo and transformed DLBCL) or Grade 3b follicular
lymphoma

- Available representative tissue from the most recent biopsy after the last therapy; if
such tissue is not available, a fresh biopsy must be obtained

- Received only frontline CD20-directed immunotherapy with anthracycline- or
anthracenedione-based multi-agent chemotherapy. Monotherapy rituximab or other
CD20-directed immunotherapy as maintenance therapy prior to frontline chemotherapy,
and radiotherapy in a limited field or as part of the frontline treatment plan are
permitted.

- Achieved a response of stable disease, partial response, or complete response
following the last cycle of frontline treatment. In addition, patients must have
relapsed less than or equal to 6 months from the completion of frontline therapy at
the time of initial dosing in this clinical trial.

- Considered eligible for high-dose chemotherapy followed by autologous stem cell
transplant (ASCT)

- Fluorodeoxyglucose (FDG)-avid disease by positive emission tomography (PET), and
measurable disease greater than 1.5 cm in diameter

- Eastern Cooperative Oncology Group (ECOG) performance less than or equal to 2

- Adequate kidney and hematologic function assessed from baseline laboratory data

Exclusion Criteria:

- Previous history of indolent lymphoma treated with more than 1 multi-agent
chemotherapy regimen or previous cancer therapy for recurrent DLBCL or Grade 3b
follicular lymphoma

- History of autologous or allogeneic stem cell transplant

- History of another primary invasive cancer, hematologic malignancy, or myelodysplastic
syndrome that has not been in remission for at least 1 year

- History of progressive multifocal leukoencephalopathy (PML)

- Cerebral/meningeal disease related to the underlying malignancy that has not been
definitively treated

- Known urinary tract obstruction

- Patients with the following ocular conditions: corneal disorders, monocular vision
(i.e., best corrected visual acuity greater than or equal to 20/200 in one eye), or
active ocular disorders requiring treatment