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: | Active, not recruiting |
---|---|
Conditions: | Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/26/2019 |
Start Date: | September 27, 2012 |
End Date: | February 12, 2019 |
A Randomized, Open-Label, Multicenter, Phase II Trial Evaluating the Safety and Activity of Pinatuzumab Vedotin (DCDT2980S) in Combination With Rituximab or Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab and a Non-Randomized Phase Ib/II Evaluation of Polatuzumab Vedotin in Combination With Obinutuzumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma
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).
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).
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 (=) 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
We found this trial at
27
sites
1721 East 19th Avenue
Denver, Colorado 80218
Denver, Colorado 80218
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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1100 Fairview Avenue North
Seattle, Washington 98109
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
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Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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8931 Colonial Center Drive
Fort Myers, Florida 33905
Fort Myers, Florida 33905
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3730 South Eastern Avenue
Las Vegas, Nevada 89169
Las Vegas, Nevada 89169
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University of Wisconsin-Madison In achievement and prestige, the University of Wisconsin-Madison has long been recognized...
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2013 Jefferson Street Southwest
Roanoke, Virginia 24014
Roanoke, Virginia 24014
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Cancer Care Centers of South Texas At Cancer Care Centers of South Texas, we are...
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