Denintuzumab Mafodotin (SGN-CD19A) Combined With RCHOP or RCHP Versus RCHOP Alone in Diffuse Large B-Cell Lymphoma or Follicular Lymphoma

• Status: Terminated
• Trial end date: 2018-05-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seagen Inc.; Seattle Genetics, Inc.
• Treatments: Antibodies; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Prednisone; Rituximab; Vincristine

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