Therapy Detail

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Therapy Name Tisagenlecleucel
Synonyms
Therapy Description

Kymriah (tisagenlecleucel) is a preparation of autologous T-lymphocytes engineered to express chimeric antigen receptors targeting CD19-positive cells, resulting in anti-tumor immune response (J Clin Oncol 35, 2017 (suppl; abstr 10523)). Kymriah (tisagenlecleucel) is FDA approved for pediatric and young adult patients with B-cell precursor acute lymphoblastic leukemia, adult patient with relapsed or refractory large B-cell lymphoma, and adult patients with relapsed or refractory follicular lymphoma (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Tisagenlecleucel Kymriah CTL019 Kymriah (tisagenlecleucel) is a preparation of autologous T-lymphocytes engineered to express chimeric antigen receptors targeting CD19-positive cells, resulting in anti-tumor immune response (J Clin Oncol 35, 2017 (suppl; abstr 10523)). Kymriah (tisagenlecleucel) is FDA approved for pediatric and young adult patients with B-cell precursor acute lymphoblastic leukemia, adult patient with relapsed or refractory large B-cell lymphoma, and adult patients with relapsed or refractory follicular 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
NCT03610724 Phase II Tisagenlecleucel Phase II Open Label Trial to Determine Safety & Efficacy of Tisagenlecleucel in Pediatric Non-Hodgkin Lymphoma Patients (BIANCA) Completed USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | AUT | AUS 4
NCT04890236 Phase I Tisagenlecleucel Duvelisib Duvelisib Exposure to Enhance Immune Profiles of T Cells in Patients With Recurrent or Refractory Diffuse Large B-Cell Lymphoma, DEEP T CELLS Study Recruiting USA 0
NCT05310591 Phase Ib/II Cyclophosphamide + Fludarabine Nivolumab Tisagenlecleucel Combination of an Anti-PD1 Antibody With Tisagenlecleucel Reinfusion in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia After Loss of Persistence (CAPTiRALL) Recruiting FRA 0
NCT02445248 Phase II Tisagenlecleucel Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients (JULIET) Completed USA | NLD | ITA | FRA | DEU | CAN | AUT | AUS 2
NCT04225676 Phase II Tisagenlecleucel Study of Efficacy and Safety of Reinfusion of Tisagenlecleucel in Pediatric and Young Adult Patients With Acute Lymphoblastic Leukemia (ALL) Terminated USA 0
NCT02228096 Phase II Tisagenlecleucel Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients Completed USA 0
NCT03123939 Phase III Tisagenlecleucel Phase III B in Acute Lymphoblastic Leukemia Completed ITA | FRA | ESP | DEU | CAN | BEL | AUT 2
NCT03568461 Phase II Tisagenlecleucel Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma (ELARA) Active, not recruiting USA | NLD | ITA | GBR | FRA | ESP | DEU | BEL | AUT | AUS 2
NCT03876769 Phase II Tisagenlecleucel Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients (CASSIOPEIA) Recruiting USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL 4
NCT05075603 Phase I Tisagenlecleucel A Study to Evaluate the Safety, Tolerability and Preliminary Anti-tumor Activity of NT-I7 (Efineptakin Alfa) Post-Tisagenlecleucel (Kymriah) in Relapsed/Refractory Large B-cell Lymphoma Subjects Recruiting USA 0
NCT02435849 Phase II Tisagenlecleucel Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients Completed USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT | AUS 2
NCT04134117 Phase I Tisagenlecleucel Tisagenlecleucel In Primary CNS Lymphoma Unknown status USA 0
NCT05888493 Phase III Cyclophosphamide + Doxorubicin + Prednisone + Rituximab + Vincristine Sulfate Tisagenlecleucel Cyclophosphamide + Doxorubicin + Prednisolone + Rituximab + Vincristine Sulfate Lenalidomide + Rituximab A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma (LEDA) Recruiting ESP | AUS 6
NCT04094311 Phase III Tisagenlecleucel Study of Out of Specification for Tisagenlecleucel Recruiting CAN 1
NCT05460533 Phase II Tisagenlecleucel A Second Infusion (Early Reinfusion) of Tisagenlecleucel in Children and Young Adults With B-Cell Acute Lymphoblastic Leukemia(B-ALL) Recruiting USA 0


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