Therapy Detail

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Therapy Name axicabtagene ciloleucel + Cyclophosphamide + Fludarabine
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Cyclophosphamide Cytoxan CPM Chemotherapy - Alkylating 18 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 CD19 Immune Cell Therapy 62 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).

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

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03153462 Expanded access axicabtagene ciloleucel + Cyclophosphamide + Fludarabine Axicabtagene Ciloleucel Expanded Access Study Approved for marketing USA 0
NCT05605899 Phase III Cyclophosphamide + Doxorubicin + Etoposide + Prednisone + Rituximab + Vincristine Sulfate axicabtagene ciloleucel + Cyclophosphamide + Fludarabine A Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma (ZUMA-23) Recruiting USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | AUT | AUS 2
NCT03642626 Phase II Cyclophosphamide + Fludarabine + Tisagenlecleucel axicabtagene ciloleucel + Cyclophosphamide + Fludarabine MT2017-45: CAR-T Cell Therapy for Heme Malignancies Active, not recruiting USA 0
NCT02601313 Phase II axicabtagene ciloleucel + Cyclophosphamide + Fludarabine A Phase 2 Multicenter Study Evaluating Subjects With Relapsed/Refractory Mantle Cell Lymphoma (ZUMA-2) Completed USA | NLD | FRA | DEU 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) Completed USA | FRA | AUS 0


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