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|Therapy Name||Cyclophosphamide + Fludarabine + KTE-C19|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Cyclophosphamide||Cytoxan||CPM||Chemotherapy - Alkylating 14||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)|
|KTE-C19||Yescarta||KTE-C19 CAR|axicabtagene ciloleucel||Yescarta (KTE-C19) 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 (Blood 2015 126:3991). Yescarta (KTE-C19) is FDA approved for treatment of relapsed or refractory large B-cell 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|
|NCT02601313||Phase II||Cyclophosphamide + Fludarabine + KTE-C19||A Phase 2 Multicenter Study Evaluating Subjects With Relapsed/Refractory Mantle Cell Lymphoma (ZUMA-2)||Active, not recruiting|
|NCT03642626||Phase II||Cyclophosphamide + Fludarabine + Tisagenlecleucel Cyclophosphamide + Fludarabine + KTE-C19||MT2017-45: CAR-T Cell Therapy for Heme Malignancies||Recruiting|
|NCT04205838||Phase II||Cyclophosphamide + Fludarabine + KTE-C19||Anakinra in Preventing Severe Chimeric Antigen Receptor T-Cell Related Encephalopathy Syndrome in Patients With Recurrent or Refractory Large B-cell Lymphoma||Not yet recruiting|
|NCT03761056||Phase II||Cyclophosphamide + Fludarabine + KTE-C19||Efficacy and Safety of Axicabtagene Ciloleucel as First-Line Therapy in Participants With High-Risk Large B-Cell Lymphoma (ZUMA-12)||Recruiting|
|NCT03153462||Expanded access||Cyclophosphamide + Fludarabine + KTE-C19||Axicabtagene Ciloleucel Expanded Access Study||Available|