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)
NCT ID: NCT01691898
Last Updated: 2020-02-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
231 participants
INTERVENTIONAL
2012-09-27
2019-02-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
For the first 2 cycles, RTX 375 milligrams per square meter (mg/m\^2) will be given by intravenous (IV) infusion on Day 1 and pinatuzumab vedotin 2.4 milligrams per kilogram (mg/kg) will be administered by IV infusion on Day 2 to Arm A participants (with r/r FL and DLBCL). In the absence of any infusion-related adverse events, RTX and pinatuzumab may be administered on the same day (Day 1) in subsequent cycles beginning with the third cycle. Participants who develop disease progression (PD) will be further treated with RTX 375 mg/m\^2 followed by polatuzumab vedotin 2.4 mg/kg IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event relative to the tumor assessment, documenting PD on the initial study treatment, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (17 cycles on an every-21-day schedule).
Pinatuzumab Vedotin
Pinatuzumab Vedotin 1.8 or 2.4 mg/kg administered by IV infusion on Day 1 or 2 of every 21-day cycle.
Polatuzumab Vedotin
Polatuzumab Vedotin 1.8 or 2.4 mg/kg administered by IV infusion on Day 1 or 2 of every 21-day cycle.
Rituximab
RTX 375 mg/m\^2 administered by IV infusion on Day 1 of every 21-day cycle.
Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
For the first 2 cycles, RTX 375 mg/m\^2 will be given by IV infusion on Day 1 and polatuzumab vedotin 2.4 mg/kg will be administered by IV infusion on Day 2 to Arm B participants (with r/r FL and DLBCL). In the absence of any infusion-related adverse events, RTX and polatuzumab may be administered on the same day (Day 1) in subsequent cycles beginning with the third cycle. Participants who develop PD would be further treated with RTX 375 mg/m\^2 followed by pinatuzumab vedotin 2.4 mg/kg IV infusion on Day 1, beginning no later than 42 days after the last dose of the prior study treatment until a second PD event relative to the tumor assessment, documenting PD on the initial study treatment, clinical deterioration, and/or intolerance to the crossover treatment for up to a maximum of 1 year (17 cycles on an every-21-day schedule).
Pinatuzumab Vedotin
Pinatuzumab Vedotin 1.8 or 2.4 mg/kg administered by IV infusion on Day 1 or 2 of every 21-day cycle.
Polatuzumab Vedotin
Polatuzumab Vedotin 1.8 or 2.4 mg/kg administered by IV infusion on Day 1 or 2 of every 21-day cycle.
Rituximab
RTX 375 mg/m\^2 administered by IV infusion on Day 1 of every 21-day cycle.
Cohort C (FL): RTX + Polatuzumab
For the first 2 cycles, RTX 375 mg/m\^2 will be given by IV infusion on Day 1 and polatuzumab vedotin 1.8 mg/kg will be administered by IV infusion on Day 2 to Cohort C participants (with r/r FL). In the absence of any infusion-related adverse events, RTX and polatuzumab may be administered on the same day (Day 1) in subsequent cycles beginning with the third cycle for up to a maximum of 1 year (17 cycles on an every-21-day schedule) or significant toxicity, PD, or withdrawal from study.
Polatuzumab Vedotin
Polatuzumab Vedotin 1.8 or 2.4 mg/kg administered by IV infusion on Day 1 or 2 of every 21-day cycle.
Rituximab
RTX 375 mg/m\^2 administered by IV infusion on Day 1 of every 21-day cycle.
Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab
For the first cycle, obinutuzumab will be given by IV infusion on Days 1, 8, and 15. Polatuzumab vedotin 1.8 mg/kg IV infusion will be given on Day 2 of the first cycle to Cohort E participants (with r/r FL and DLBCL). In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin may be administered on the same day (Day 1) in subsequent cycles beginning with the second cycle up to a maximum of 8 cycles or significant toxicity, PD, or withdrawal from study.
Obinutuzumab
Obinutuzumab 1000 mg will be administered by IV infusion on Days 1, 8, 15 of first 21-Day cycle and on Day 1 of subsequent 21-day cycles for up to 8 cycles.
Polatuzumab Vedotin
Polatuzumab Vedotin 1.8 or 2.4 mg/kg administered by IV infusion on Day 1 or 2 of every 21-day cycle.
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
For the first cycle, obinutuzumab will be given by IV infusion on Days 1, 8, and 15. Polatuzumab vedotin 1.8 mg/kg IV infusion will be given on Day 2 of the first cycle to Cohort G participants (with r/r FL). In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin may be administered on the same day (Day 1) in subsequent cycles beginning with the second cycle of the dose-expansion period to cohort G participants up to a maximum of 8 cycles or significant toxicity, PD, or withdrawal from study.
Obinutuzumab
Obinutuzumab 1000 mg will be administered by IV infusion on Days 1, 8, 15 of first 21-Day cycle and on Day 1 of subsequent 21-day cycles for up to 8 cycles.
Polatuzumab Vedotin
Polatuzumab Vedotin 1.8 or 2.4 mg/kg administered by IV infusion on Day 1 or 2 of every 21-day cycle.
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
For the first cycle, obinutuzumab will be given by IV infusion on Days 1, 8, and 15. Polatuzumab vedotin 1.8 mg/kg IV infusion will be given on Day 2 of the first cycle to Cohort H participants (with r/r DLBCL). In the absence of any infusion-related adverse events, obinutuzumab and polatuzumab vedotin may be administered on the same day (Day 1) in subsequent cycles beginning with the second cycle of the dose-expansion period to cohort H participants up to a maximum of 8 cycles or significant toxicity, PD, or withdrawal from study.
Obinutuzumab
Obinutuzumab 1000 mg will be administered by IV infusion on Days 1, 8, 15 of first 21-Day cycle and on Day 1 of subsequent 21-day cycles for up to 8 cycles.
Polatuzumab Vedotin
Polatuzumab Vedotin 1.8 or 2.4 mg/kg administered by IV infusion on Day 1 or 2 of every 21-day cycle.
Interventions
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Obinutuzumab
Obinutuzumab 1000 mg will be administered by IV infusion on Days 1, 8, 15 of first 21-Day cycle and on Day 1 of subsequent 21-day cycles for up to 8 cycles.
Pinatuzumab Vedotin
Pinatuzumab Vedotin 1.8 or 2.4 mg/kg administered by IV infusion on Day 1 or 2 of every 21-day cycle.
Polatuzumab Vedotin
Polatuzumab Vedotin 1.8 or 2.4 mg/kg administered by IV infusion on Day 1 or 2 of every 21-day cycle.
Rituximab
RTX 375 mg/m\^2 administered by IV infusion on Day 1 of every 21-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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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
Univ of Wisconsin-Madison
Madison, Wisconsin, United States
Cross Cancer Institute
Edmonton, Alberta, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal, Quebec, Canada
Hopital Claude Huriez - CHU Lille
Lille, , France
CHU Montpellier - Saint ELOI
Montpellier, , France
Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Centre Henri Becquerel; Hematologie
Rouen, , France
Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V
Heidelberg, , Germany
Universitätsmedizin Johannes Gutenberg Universität; Klinik u. Poliklinik f. Neurologie
Mainz, , Germany
Klinikum d.Universität München Campus Großhadern
München, , Germany
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
Bologna, Emilia-Romagna, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milan, Lombardy, Italy
Azienda Ospedale San Giovanni
Turin, Piedmont, Italy
Academisch Medisch Centrum; Hematologie
Amsterdam, , Netherlands
Countries
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References
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Shi R, Lu T, Ku G, Ding H, Saito T, Gibiansky L, Agarwal P, Li X, Jin JY, Girish S, Miles D, Li C, Lu D. Asian race and origin have no clinically meaningful effects on polatuzumab vedotin pharmacokinetics in patients with relapsed/refractory B-cell non-Hodgkin lymphoma. Cancer Chemother Pharmacol. 2020 Sep;86(3):347-359. doi: 10.1007/s00280-020-04119-8. Epub 2020 Aug 8.
Lu T, Gibiansky L, Li X, Li C, Shi R, Agarwal P, Hirata J, Miles D, Chanu P, Girish S, Jin JY, Lu D. Exposure-safety and exposure-efficacy analyses of polatuzumab vedotin in patients with relapsed or refractory diffuse large B-cell lymphoma. Leuk Lymphoma. 2020 Dec;61(12):2905-2914. doi: 10.1080/10428194.2020.1795154. Epub 2020 Jul 24.
Morschhauser F, Flinn IW, Advani R, Sehn LH, Diefenbach C, Kolibaba K, Press OW, Salles G, Tilly H, Chen AI, Assouline S, Cheson BD, Dreyling M, Hagenbeek A, Zinzani PL, Jones S, Cheng J, Lu D, Penuel E, Hirata J, Wenger M, Chu YW, Sharman J. Polatuzumab vedotin or pinatuzumab vedotin plus rituximab in patients with relapsed or refractory non-Hodgkin lymphoma: final results from a phase 2 randomised study (ROMULUS). Lancet Haematol. 2019 May;6(5):e254-e265. doi: 10.1016/S2352-3026(19)30026-2. Epub 2019 Mar 29.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2011-004377-84
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GO27834
Identifier Type: -
Identifier Source: org_study_id
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