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 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).

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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...

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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


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