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)
Completed · Phase 1/Phase 2
Conditions studied: Follicular Lymphoma, Diffuse Large B-Cell Lymphoma
In brief
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).
Key facts
- Study ID
- NCT01691898
- Run by
- Genentech, Inc.
- People needed
- 231
- Starts
- 2012-09-27
- Expected to finish
- 2019-02-07
- Last updated by the study team
- 2020-02-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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])
You may not qualify if…
- 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 (</=) 2 prior study start
- 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
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- Stanford Cancer Center — Stanford, California, United States
- Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center — Denver, Colorado, United States
- Georgetown University Medical Center Lombardi Cancer Center — Washington D.C., District of Columbia, United States
- Florida Cancer Specialists - Fort Myers (Colonial Center Dr) — Fort Myers, Florida, United States
- Florida Cancer Specialists; Sarasota — Sarasota, Florida, United States
- Univ of Michigan Med School; Hematology Oncology — Ann Arbor, Michigan, United States
- Comprehensive Cancer Centers of Nevada - Eastern Avenue — Las Vegas, Nevada, United States
- Hematology Oncology Associates; Carol G. Simon Ctr — Morristown, New Jersey, United States
- Regional Cancer Care Associates LLC - Morristown — Morristown, New Jersey, United States
- Roswell Park Cancer Inst. — Buffalo, New York, United States
- New York University Cancer Cen — New York, New York, United States
- Oncology Hematology Care Inc — Cincinnati, Ohio, United States
- Willamette Valley Cancer Ctr - 520 Country Club — Eugene, Oregon, United States
- Oregon Health Sciences Uni — Portland, Oregon, United States
- Sarah Cannon Cancer Center - Tennessee Oncology, Pllc — Nashville, Tennessee, United States
- Texas Oncology-Baylor Sammons Cancer Center — Dallas, Texas, United States
- Cancer Care Centers of South Texas — San Antonio, Texas, United States
- Texas Transplant Inst. — San Antonio, Texas, United States
- Texas Oncology, P.A. - Tyler; Tyler Cancer Center — Tyler, Texas, United States
- Fairfax N Virginia Hem/Onc PC — Fairfax, Virginia, United States
- Oncology & Hematolgy Associates of SW Va Inc. - Roanoke — Roanoke, Virginia, United States
- Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
- Northwest Cancer Specialists - Vancouver — Vancouver, Washington, United States
- Yakima Valley Memorial Hospital/North Star Lodge — Yakima, Washington, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.