A Study of Pinatuzumab Vedotin (DCDT2980S) Combined With Rituximab or Polatuzumab Vedotin (DCDS4501A) Combined With Rituximab or Obinutuzumab in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)

• Status: Completed
• Trial end date: 2019-02-07
• Target enrollment: 0
• Participant gender: All

Summary

This multicenter, open-label study will evaluate the safety and efficacy of pinatuzumab vedotin (DCDT2980S) or polatuzumab vedotin (DCDS4501A) in combination with rituximab (RTX), as well as of polatuzumab vedotin in combination with obinutuzumab in participants with relapsed or refractory (r/r) follicular lymphoma (FL) and r/r diffuse large B-cell lymphoma (DLBCL).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Antibodies, Monoclonal; Immunoconjugates; Obinutuzumab; Rituximab

Criteria

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2

• Life expectancy of at least 12 weeks

• History of histologically documented r/r Grades 1 to 3a FL, or r/r DLBCL

• Availability of an archival or freshly biopsied tumor tissue sample must be confirmed for study enrollment

• Have a clinical indication for treatment as determined by the investigator

• Must have at least one bi-dimensionally measurable lesion (greater than [>] 1.5 centimeters [cm] in its largest dimension by CT scan or Magnetic Resonance Imaging [MRI])

Exclusion Criteria:

• Prior use of any monoclonal antibody, radio-immuno-conjugate or antibody drug conjugate within 4 weeks before study start

• Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational anti-cancer agent within 2 weeks prior study start

• Adverse events except for sensory neuropathy from any previous treatments must be resolved or stabilized to Grade less than equal to (
• Completion of autologous stem cell transplant (SCT) within 100 days prior study start

• Prior allogeneic SCT

• Eligibility for autologous SCT (participants with r/r DLBCL)

• History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)

• History of other malignancy that could affect compliance with the protocol or interpretation of results

• Current or past history of central nervous system lymphoma

• Current Grade >1 peripheral neuropathy

• Vaccination with a live vaccine within 28 days prior to treatment