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 | CD19 Immune Cell Therapy 62 | 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 |
|---|---|---|---|---|---|---|
| NCT03568461 | Phase II | Tisagenlecleucel | Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma (ELARA) | Active, not recruiting | USA | NOR | NLD | ITA | GBR | FRA | ESP | DEU | BEL | AUT | AUS | 1 |
| NCT04134117 | Phase I | Tisagenlecleucel | Tisagenlecleucel In Primary CNS Lymphoma | Completed | USA | 0 |
| NCT02228096 | Phase II | Tisagenlecleucel | Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients | Completed | 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 | SVK | ROU | POL | HUN | ESP | CZE | AUS | 3 |
| NCT02445248 | Phase II | Tisagenlecleucel | Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients (JULIET) | Completed | USA | NOR | NLD | ITA | FRA | DEU | CAN | AUT | AUS | 1 |
| NCT03123939 | Phase III | Tisagenlecleucel | Phase III B in Acute Lymphoblastic Leukemia | Completed | NOR | ITA | FRA | ESP | DEU | CAN | BEL | AUT | 1 |
| 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 |
| 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 |
| NCT04094311 | Phase III | Tisagenlecleucel | Study of Out of Specification for Tisagenlecleucel | Recruiting | CAN | 1 |
| NCT03876769 | Phase II | Tisagenlecleucel | Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients (CASSIOPEIA) | Active, not recruiting | USA | SWE | NOR | NLD | ITA | GBR | FRA | ESP | DNK | CAN | BEL | 0 |
| NCT02435849 | Phase II | Tisagenlecleucel | Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients | Completed | USA | NOR | ITA | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 1 |
| 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 |
| 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 |
| NCT06408194 | Phase I | Tisagenlecleucel Anti-CD22 CAR T cells | Autologous CD22 CAR T Cells Following Commercial CD19 CAR T Cells in B Cell Malignancies | Recruiting | USA | 0 |
| NCT03610724 | Phase II | Tisagenlecleucel | Phase II Open Label Trial to Determine Safety & Efficacy of Tisagenlecleucel in Pediatric Non-Hodgkin Lymphoma Patients (BIANCA) | Completed | USA | NOR | NLD | ITA | GBR | FRA | FIN | ESP | DNK | DEU | CAN | AUT | AUS | 1 |
| 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 |
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