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|Therapy Name||axicabtagene ciloleucel + Cyclophosphamide + Fludarabine|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Cyclophosphamide||Cytoxan||CPM||Chemotherapy - Alkylating 16||Cytoxan (cyclophosphamide) is an alkylating agent, which inhibits DNA replication (NCI Drug Dictionary). Cytoxan (cyclophosphamide) is FDA approved in multiple hematological malignancies, breast cancer, neuroblastoma, ovarian cancer, and retinoblastoma (NCI Drug Dictionary).|
|Fludarabine||Fludara||FAMP|Fludarabine phosphate||Flurdara (fludarabine) is converted to 2-fluoro-ara-ATP intracellularly, which potentially inhibits DNA polymerase alpha, ribonucleotide reductase and DNA primase, leading to decreased DNA synthesis and reduced tumor growth (NCI Drug Dictionary)|
|axicabtagene ciloleucel||Yescarta||KTE-C19 CAR|KTE-C19||Yescarta (axicabtagene ciloleucel) is an immunotherapy consisted of peripheral T-lymphocytes engineered to express a chimeric antigen receptor targeting CD19, CD28 and CD3zeta, resulting in immunostimulating and antineoplastic activities (PMID: 32401634). Yescarta (axicabtagene ciloleucel) is FDA approved for adult patients with large B-cell lymphoma who is refractory or relapsed on first-line chemoimmunotherapy or have received two or more lines of therapies, including diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma, and for adult patients with relapsed or refractory follicular lymphoma who have received two or more lines of therapies, but is not indicated for patients with primary central nervous system lymphoma (FDA.gov).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT03642626||Phase II||Cyclophosphamide + Fludarabine + Tisagenlecleucel axicabtagene ciloleucel + Cyclophosphamide + Fludarabine||MT2017-45: CAR-T Cell Therapy for Heme Malignancies||Recruiting||USA||0|
|NCT03761056||Phase II||axicabtagene ciloleucel + Cyclophosphamide + Fludarabine||Efficacy and Safety of Axicabtagene Ciloleucel as First-Line Therapy in Participants With High-Risk Large B-Cell Lymphoma (ZUMA-12)||Active, not recruiting||USA | FRA||1|
|NCT03153462||Expanded access||axicabtagene ciloleucel + Cyclophosphamide + Fludarabine||Axicabtagene Ciloleucel Expanded Access Study||Approved for marketing||USA||0|
|NCT02601313||Phase II||axicabtagene ciloleucel + Cyclophosphamide + Fludarabine||A Phase 2 Multicenter Study Evaluating Subjects With Relapsed/Refractory Mantle Cell Lymphoma (ZUMA-2)||Active, not recruiting||USA | FRA | DEU||1|