Therapy Detail

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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).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Obinutuzumab Gazyva R7159|afutuzumab|GA101|GA-101|RO 5072759 CD20 Antibody 21 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).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
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...
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...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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
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
NCT02498951 Phase II Obinutuzumab Maintenance Obinutuzumab in Treating Patients With Central Nervous System Lymphoma Who Have Achieved a Complete or Partial Response Terminated 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
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
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 | FRA | ESP | CAN | AUT | AUS 2
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 | GBR | FRA | ESP | DEU | BEL | AUS 7
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
NCT06213311 Phase II Obinutuzumab axicabtagene ciloleucel + Glofitamab-gxbm A Phase 2 Study of Axicabtagene Ciloleucel and Glofitamab as Second-Line Therapy for Relapsed or Refractory Patients With Large B Cell Lymphoma Recruiting 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 | ITA | GBR | FRA | ESP | CAN | AUS 5
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 | NZL | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 8
NCT03341520 Phase II Obinutuzumab Gazyvaro and Low Dose Radiotherapy in Early Stage Follicular Lymphoma (GAZAI) Active, not recruiting DEU 0
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
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 | DEU | AUS 2
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
NCT05894447 Phase I Naptumomab estafenatox + Pembrolizumab Obinutuzumab Naptumomab Estafenatox in Combination With Pembrolizumab Preceded by Obinutuzumab in Patients With Urothelial Cancers Withdrawn USA 0
NCT03322865 Phase II Obinutuzumab Obinutuzumab in Marginal Zone Lymphoma Active, not recruiting DEU 0
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 | NZL | ITA | GBR | FRA | ESP | DEU | CAN | AUS 8
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
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 | NLD | ITA | GBR | FRA | ESP | DEU | CAN | AUS 4


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