Polatuzumab vedotin
- Generic Name
- Polatuzumab vedotin
- Brand Names
- Polivy
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 1313206-42-6
- Unique Ingredient Identifier
- KG6VO684Z6
- Background
Polatuzumab vedotin is a CD79b-directed antibody-drug conjugate that delivers monomethyl auristatin E (MMAE), an anti-mitotic agent, to cancer cells. The drug consists of three components - a humanized immunoglobulin G1 (IgG1) monoclonal antibody specific for human CD79b (polatuzumab), MMAE, and protease-cleavable linker called maleimidocaproyl-valine-citrul...
- Indication
Polatuzumab vedotin is used in combination with bendamustine and rituximab to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, after at least two prior therapies. In Canada, this indication is approved for patients who are not eligible for autologous stem cell transplant and have received at least one p...
- Associated Conditions
- Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Epstein-Barr Virus-positive Diffuse Large B-cell Lymphoma, High-grade B Cell Lymphoma (HGBCL), Large B Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, T-Cell/Histiocyte-Rich Large B-Cell Lymphoma, Relapsed Diffuse large B-cell lymphoma NOS
- Associated Therapies
- -
Polatuzumab Vedotin and Combination Chemotherapy for the Treatment of Untreated Aggressive Large B-cell Lymphoma
- Conditions
- Aggressive Non-Hodgkin LymphomaALK-Positive Large B-Cell LymphomaDiffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedEBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedHigh Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 RearrangementsHigh Grade B-Cell Lymphoma, Not Otherwise SpecifiedPrimary Mediastinal Large B-Cell LymphomaT-Cell/Histiocyte-Rich Large B-Cell LymphomaGray-Zone Lymphoma
- Interventions
- Drug: Polatuzumab VedotinBiological: RituximabDrug: PrednisoneDrug: EtoposideDrug: DoxorubicinDrug: CyclophosphamideProcedure: Multigated Acquisition ScanBiological: GlofitamabProcedure: EchocardiographyProcedure: FDG-Positron Emission TomographyProcedure: Computed TomographyProcedure: Bone Marrow BiopsyProcedure: Biospecimen CollectionProcedure: Bone Marrow Aspiration
- First Posted Date
- 2020-01-18
- Last Posted Date
- 2024-09-30
- Lead Sponsor
- University of Washington
- Target Recruit Count
- 56
- Registration Number
- NCT04231877
- Locations
- 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States
A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2019-12-02
- Last Posted Date
- 2024-10-30
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 270
- Registration Number
- NCT04182204
- Locations
- 🇺🇸
Memorial Regional Hospital, Hollywood, Florida, United States
🇺🇸Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy), Jacksonville, Florida, United States
🇺🇸Memorial Cancer Institute at Memorial West, Pembroke Pines, Florida, United States
Trial of Mosunetuzumab (BTCT4465A) as Consolidation Therapy in Participants With Diffuse Large B-Cell Lymphoma Following First-Line Immunochemotherapy and as Monotherapy or in Combination With Polatuzumab Vedotin in Elderly/Unfit Participants With Previously Untreated Diffuse Large B-Cell Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2018-09-19
- Last Posted Date
- 2024-10-07
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 188
- Registration Number
- NCT03677154
- Locations
- 🇺🇸
Fort Wayne Medical Institute, Fort Wayne, Indiana, United States
🇺🇸Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
🇺🇸University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, United States
A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma
- First Posted Date
- 2018-09-19
- Last Posted Date
- 2024-12-18
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 117
- Registration Number
- NCT03677141
- Locations
- 🇺🇸
University of Alabama Birmingham, Birmingham, Alabama, United States
🇺🇸Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
🇺🇸University of California; Moores Cancer Center, La Jolla, California, United States
A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2018-09-14
- Last Posted Date
- 2024-11-28
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 422
- Registration Number
- NCT03671018
- Locations
- 🇺🇸
University of Pittsburgh - Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
🇺🇸University of Miami Miller School of Medicine, Miami, Florida, United States
🇺🇸University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States
An Open-Label Phase lB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2018-05-23
- Last Posted Date
- 2024-10-16
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 211
- Registration Number
- NCT03533283
- Locations
- 🇧🇪
UZ Gent, Gent, Belgium
🇺🇸Novant Health Cancer Institute, Charlotte, North Carolina, United States
🇩🇰Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT, København Ø, Denmark
A Study of Glofitamab in Combination With Rituximab or Obinutuzumab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (CHP) in Participants With Non-Hodgkin Lymphomas or With DLBCL
- Conditions
- Interventions
- First Posted Date
- 2018-03-16
- Last Posted Date
- 2024-10-22
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 172
- Registration Number
- NCT03467373
- Locations
- 🇩🇰
Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT, København Ø, Denmark
🇺🇸University of Alabama Medical Center, Birmingham, Alabama, United States
🇺🇸Fox Chase-Temple Cancer Center, Philadelphia, Pennsylvania, United States
A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2017-09-07
- Last Posted Date
- 2024-10-04
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 1000
- Registration Number
- NCT03274492
- Locations
- 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸Southern Cancer Center, Daphne, Alabama, United States
🇺🇸City of Hope, Duarte, California, United States
A Study Evaluating Safety and Efficacy of Obinutuzumab, Polatuzumab Vedotin (Pola), and Atezolizumab (Atezo) in Participants With Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab, Atezo, and Pola in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
- Conditions
- Interventions
- First Posted Date
- 2016-04-06
- Last Posted Date
- 2020-12-23
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 36
- Registration Number
- NCT02729896
- Locations
- 🇵🇱
Instytut Hematologii i Transfuzjologii; Klinika Zaburzeń Hemostazy i Chorób Wewnętrznych, Warsaw, Poland
🇺🇸UCLA, Los Angeles, California, United States
🇺🇸University Miami, Miami, Florida, United States
A Study of Obinutuzumab, Rituximab, Polatuzumab Vedotin, and Venetoclax in Relapsed or Refractory Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL)
- Conditions
- Interventions
- First Posted Date
- 2015-11-20
- Last Posted Date
- 2023-10-10
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 133
- Registration Number
- NCT02611323
- Locations
- 🇮🇹
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori, Meldola, Emilia-Romagna, Italy
🇮🇹Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy
🇮🇹SCDU Ematologia, Novara, Piemonte, Italy
Drug Development Updates
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