A Study of Escalating Doses of Polatuzumab Vedotin in Participants With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma and Chronic Lymphocytic Leukemia and Polatuzumab Vedotin in Combination With Rituximab in Participants With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma
NCT ID: NCT01290549
Last Updated: 2017-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
95 participants
INTERVENTIONAL
2011-03-22
2014-11-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Polatuzumab Vedotin
Polatuzumab vedotin will be administered by an IV infusion of escalating doses (starting dose of 0.1 mg/kg, potentially to be followed by 0.25 mg/kg, 0.5 mg/kg, 1.0 mg/kg, 2.0 mg/kg, and 4.0 mg/kg doses) every 3 weeks (q3w) (Day 1 of each 21 day cycle).
Polatuzumab Vedotin
Participants will receive escalating intravenous dose of polatuzumab vedotin.
Polatuzumab Vedotin + Rituximab
Polatuzumab vedotin will be administered by an IV infusion q3w (Day 1 of each 21 day cycle). Rituximab was administered by an IV infusion at 375 milligrams per square meter (mg/m\^2) body surface area dose q3w.
Polatuzumab Vedotin
Participants will receive escalating intravenous dose of polatuzumab vedotin.
Rituximab
Rituximab will be administered by an IV infusion at 375 mg/m\^2 body surface area dose q3w.
Interventions
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Polatuzumab Vedotin
Participants will receive escalating intravenous dose of polatuzumab vedotin.
Rituximab
Rituximab will be administered by an IV infusion at 375 mg/m\^2 body surface area dose q3w.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* History of one of the following histologically-documented hematologic malignancy for which no effective standard therapy exists: indolent non Hodgkin's lymphoma (NHL), Grade 3b follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL)
* All participants (NHL and B-cell chronic lymphocytic leukemia \[B-CLL\]) must have at least one bi-dimensionally measurable lesion
* For all men or women of childbearing potential (unless surgically sterile): use of adequate methods of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly
Exclusion Criteria
* Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other investigational anti-cancer agent within 2 weeks prior to Cycle 1, Day 1. Adverse events from any previous treatments must be resolved or stabilized prior to Cycle 1, Day 1, except for neuropathy
* Completion of autologous stem cell transplant within 100 days prior to Cycle 1, Day 1
* Prior allogeneic stem cell transplant
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Yu-Waye Chu, M.D.
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Stanford Cancer Center
Stanford, California, United States
Stanford Cancer Institute Pharmacy
Stanford, California, United States
Florida Cancer Specialists; Sarasota
Sarasota, Florida, United States
Roswell Park Cancer Inst.
Buffalo, New York, United States
Sarah Cannon Cancer Center
Germantown, Tennessee, United States
M.D Anderson Cancer Center; Oncology
Houston, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Cross Cancer Institute ; Dept of Medical Oncology
Edmonton, Alberta, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal, Quebec, Canada
CHU Dijon - SCE Hemato
Dijon, , France
Centre Hospitalier Regional Universitaire de Lille
Lille, , France
CHU Lapeyronie, Hematologie
Montpellier, , France
Centre Hospitalier Lyon Sud; Hematolgie
Pierre-Bénite, , France
Centre Henri Becquerel; Hematologie
Rouen, , France
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.
Palanca-Wessels MC, Czuczman M, Salles G, Assouline S, Sehn LH, Flinn I, Patel MR, Sangha R, Hagenbeek A, Advani R, Tilly H, Casasnovas O, Press OW, Yalamanchili S, Kahn R, Dere RC, Lu D, Jones S, Jones C, Chu YW, Morschhauser F. Safety and activity of the anti-CD79B antibody-drug conjugate polatuzumab vedotin in relapsed or refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukaemia: a phase 1 study. Lancet Oncol. 2015 Jun;16(6):704-15. doi: 10.1016/S1470-2045(15)70128-2. Epub 2015 Apr 27.
Related Links
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Link to the publication
Other Identifiers
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GO01294
Identifier Type: OTHER
Identifier Source: secondary_id
2011-002330-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DCS4968g
Identifier Type: -
Identifier Source: org_study_id
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