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Therapy Name | Obinutuzumab |
Synonyms | |
Therapy Description |
Gazyva (obinutuzumab) is a glycoengineered anti-CD20 antibody that binds to CD20 on B-cells, resulting in increased antibody-dependent cellular cytotoxicity and induction of apoptosis, and potentially leading to decreased growth of B-cell tumors (PMID: 20194898, PMID: 21220500). Gazyva (obinutuzumab) is FDA approved in combination with Ambochlorin (chlorambucil) for chronic lymphocytic leukemia and in combination with Treanda (bendamustine) or chemotherapy for follicular lymphoma (FDA.gov). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Obinutuzumab | Gazyva | R7159|afutuzumab|GA101|GA-101|RO 5072759 | CD20 Antibody 24 | Gazyva (obinutuzumab) is a glycoengineered anti-CD20 antibody that binds to CD20 on B-cells, resulting in increased antibody-dependent cellular cytotoxicity and induction of apoptosis, and potentially leading to decreased growth of B-cell tumors (PMID: 20194898, PMID: 21220500). Gazyva (obinutuzumab) is FDA approved in combination with Ambochlorin (chlorambucil) for chronic lymphocytic leukemia and in combination with Treanda (bendamustine) or chemotherapy for follicular lymphoma (FDA.gov). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
TP53 loss | chronic lymphocytic leukemia/small lymphocytic lymphoma | sensitive | Obinutuzumab | Guideline | Actionable | Gazyva (obinutuzumab) is indicated in the guidelines as first line therapy for chronic lymphocytic leukemia/small lymphocytic lymphoma patients with TP53 loss (NCCN.org). | detail... |
TP53 mutant | chronic lymphocytic leukemia/small lymphocytic lymphoma | sensitive | Obinutuzumab | Guideline | Actionable | Gazyva (obinutuzumab) is indicated in the guidelines as first line therapy for chronic lymphocytic leukemia/small lymphocytic lymphoma patients with a TP53 mutation (NCCN.org). | detail... |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT06651970 | FDA approved | Obinutuzumab Zanubrutinib Rituximab Acalabrutinib Venetoclax | Acalabrutinib Monotherapy vs Investigator's Choice of Treatment in Patients With CL Leukaemia and Heart Failure | Not yet recruiting | USA | POL | ITA | GBR | ESP | CZE | 0 |
NCT05894447 | Phase I | Naptumomab estafenatox + Pembrolizumab Obinutuzumab | Naptumomab Estafenatox in Combination With Pembrolizumab Preceded by Obinutuzumab in Patients With Urothelial Cancers | Withdrawn | USA | 0 |
NCT05833763 | Phase II | Glofitamab-gxbm Glofitamab-gxbm + Pirtobrutinib Obinutuzumab | A Phase 2 Trial of GlOfitamab anD pIrtobrutinib in Mantle Cell Lymphoma Patients With Prior BTK Inhibitor Exposure. (GOlDiLOX) | Recruiting | AUS | 0 |
NCT04722601 | Phase Ib/II | Azacitidine + Venetoclax Azacitidine + Obinutuzumab + Venetoclax Obinutuzumab | A Dose-Finding and Efficacy Study of Venetoclax, CC-486, and Obinutuzumab in Follicular Lymphoma | Terminated | USA | 0 |
NCT06084936 | Phase III | Obinutuzumab Glofitamab-gxbm Lenalidomide + Rituximab Bendamustine + Rituximab | A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma (GLOBRYTE) | Recruiting | USA | SWE | ITA | GBR | FRA | ESP | CAN | BRA | AUS | 3 |
NCT03671018 | Phase I | Cyclophosphamide + Doxorubicin + Prednisone + Rituximab + Vincristine Sulfate Cyclophosphamide + Prednisone + Rituximab + Vincristine Sulfate Bendamustine + Polatuzumab vedotin-piiq + Rituximab Bendamustine + Obinutuzumab Mosunetuzumab-axgb + Polatuzumab vedotin-piiq Mosunetuzumab-axgb Obinutuzumab Tocilizumab | A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma | Active, not recruiting | USA | GBR | ESP | CAN | BEL | 0 |
NCT02055820 | Phase I | Venetoclax Rituximab Cyclophosphamide + Doxorubicin + Prednisone + Vincristine Sulfate Obinutuzumab | A Safety and Pharmacokinetics Study of GDC-0199 (ABT-199) in Patients With Non-Hodgkin's Lymphoma | Completed | USA | NLD | ITA | HUN | FRA | ESP | CZE | CAN | AUT | AUS | 0 |
NCT05533775 | Phase Ib/II | Glofitamab-gxbm Carboplatin + Etoposide + Glofitamab-gxbm + Ifosfamide + Rituximab Tocilizumab Obinutuzumab | A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma (iMATRIX GLO) | Recruiting | USA | ITA | FRA | ESP | DNK | DEU | AUS | 1 |
NCT03332017 | Phase II | Obinutuzumab + Zanubrutinib Obinutuzumab | A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma | Active, not recruiting | USA | POL | NZL | ITA | GBR | FRA | ESP | DEU | CZE | CAN | BGR | AUS | 5 |
NCT03432741 | Phase I | Carfilzomib Daratumumab Obinutuzumab Gemcitabine Trastuzumab Romidepsin Nivolumab Rituximab Belinostat Pembrolizumab | Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer | Suspended | USA | 0 |
NCT03113422 | Phase II | Obinutuzumab Obinutuzumab + Venetoclax Bendamustine + Obinutuzumab + Venetoclax | Phase II Venetoclax, Obinutuzumab and Bendamustine in High Tumor Burden Follicular Lymphoma as Front Line Therapy (PrE0403) | Completed | USA | 0 |
NCT02406742 | Phase Ib/II | Obinutuzumab Rituximab Ibrutinib CC-122 | A Phase 1/2, Open-label, Dose Finding Study to Evaluate CC-122 in Combination With Rituximab, Ibrutinib and Obinutuzumab in Subjects With Relapsed/Refractory CLL/SLL (ENHANCE) | Completed | USA | ITA | ESP | DEU | AUT | 0 |
NCT04408638 | Phase III | Obinutuzumab Gemcitabine + Oxaliplatin + Rituximab Gemcitabine + Glofitamab-gxbm + Oxaliplatin | A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma | Active, not recruiting | USA | POL | GBR | FRA | ESP | DNK | DEU | CHE | BEL | AUS | 4 |
NCT03322865 | Phase II | Obinutuzumab | Obinutuzumab in Marginal Zone Lymphoma | Active, not recruiting | DEU | 0 |
NCT06213311 | Phase II | Obinutuzumab axicabtagene ciloleucel + Glofitamab-gxbm | A Study of Axicabtagene Ciloleucel and Glofitamab as Second-Line Therapy for Relapsed or Refractory Patients With Large B Cell Lymphoma | Recruiting | USA | 0 |
NCT04920968 | Phase II | Rituximab Obinutuzumab | Obinutuzumab Versus Rituximab for Acute Lymphoblastic Leukemia/PALG ALL7 OVERALL (PALG ALL7) | Not yet recruiting | POL | 0 |
NCT03341520 | Phase II | Obinutuzumab | Gazyvaro and Low Dose Radiotherapy in Early Stage Follicular Lymphoma (GAZAI) | Active, not recruiting | DEU | 0 |
NCT01992653 | Phase I | Cyclophosphamide + Doxorubicin + Prednisone Rituximab Polatuzumab vedotin-piiq Obinutuzumab | A Study of Polatuzumab Vedotin in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Participants With B-Cell Non-Hodgkin's Lymphoma | Completed | USA | FRA | 0 |
NCT06175000 | Phase II | Obinutuzumab | Maintenance Obinutuzumab in Treating Patients With Central Nervous System Lymphoma Who Have Achieved a Complete or Partial Response | Recruiting | USA | 0 |
NCT02257567 | Phase Ib/II | Bendamustine + Rituximab Polatuzumab vedotin-piiq Obinutuzumab | A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma | Completed | USA | TUR | NLD | ITA | HUN | GBR | FRA | ESP | DEU | CZE | CAN | AUS | 1 |
NCT06291220 | Phase I | Obinutuzumab ABBV-453 | A Study Assessing Adverse Event and How Oral ABBV-453 Moves Through the Body in Adult Participants With Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) | Recruiting | USA | ISR | DEU | AUS | 0 |
NCT02475681 | Phase III | Acalabrutinib Chlorambucil Obinutuzumab | Elevate CLL TN: Study of Obinutuzumab + Chlorambucil, ACP-196 + Obinutuzumab, and ACP-196 in Subjects With Previously Untreated CLL | Active, not recruiting | USA | SWE | POL | NZL | LTU | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CAN | BRA | BEL | AUS | 2 |