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|Therapy Name||Chlorambucil + Obinutuzumab|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Obinutuzumab||Gazyva||R7159|afutuzumab|GA101|GA-101|RO 5072759||CD20 Antibody 12||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|
|Unknown unknown||chronic lymphocytic leukemia||not applicable||Chlorambucil + Obinutuzumab||FDA approved||Actionable||In a Phase III trial that supported FDA approval, treatment with Gazyva (obinutuzumab) plus chlorambucil resulted in an improved median progression-free survival of 23.0 months, compared to 11.1 months with chlorambucil alone, and an overall response rate of 75.9% vs. 32.1% with chlorambucil in patients with previously untreated CD20-positive chronic lymphocytic leukemia (PMID: 24824310).||detail... 24824310|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT02612311||Phase III||Ublituximab Chlorambucil + Obinutuzumab Umbralisib||Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia||Active, not recruiting||USA | ITA | GBR | ESP||3|
|NCT02242942||Phase III||Chlorambucil + Obinutuzumab Obinutuzumab + Venetoclax||A Study to Compare the Efficacy and Safety of Obinutuzumab + GDC-0199 Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia||Active, not recruiting||USA | NZL | ITA | GBR | FRA | ESP | DEU | CAN | AUT | AUS||11|
|NCT01980875||Phase III||Idelalisib + Obinutuzumab Chlorambucil + Obinutuzumab||Efficacy and Safety of Idelalisib in Combination With Obinutuzumab Compared to Chlorambucil in Combination With Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia||Terminated||USA | GBR | FRA | ESP | CAN | BEL | AUS||1|
|NCT03462719||Phase III||Chlorambucil + Obinutuzumab Ibrutinib + Venetoclax||A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)||Active, not recruiting||USA | GBR | FRA | ESP | CAN | BEL||8|