Therapy Detail
Contact
Missing content? – Request curation!
Request curation for specific Genes, Variants, or PubMed publications.
Have questions, comments, or suggestions? - Let us know!
Email us at : ckbsupport@jax.org
| 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). |
Filtering
- Case insensitive filtering will display rows if any text in any cell matches the filter term
- Use simple literal full or partial string matches
- Separate multiple filter terms with a space. Any order may be used (i. e. a b c and c b a are equivalent )
- Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
- Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")
Sorting
- Generally, the default sort order for tables is set to be first column ascending; however, specific tables may set a different default sort order.
- Click on any column header arrows to sort by that column
- Hold down the Shift key and click multiple columns to sort by more than one column. Be sure to set ascending or descending order for a given column before moving on to the next column.
| 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). |
Filtering
- Case insensitive filtering will display rows if any text in any cell matches the filter term
- Use simple literal full or partial string matches
- Separate multiple filter terms with a space. Any order may be used (i. e. a b c and c b a are equivalent )
- Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
- Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")
Sorting
- Generally, the default sort order for tables is set to be first column ascending; however, specific tables may set a different default sort order.
- Click on any column header arrows to sort by that column
- Hold down the Shift key and click multiple columns to sort by more than one column. Be sure to set ascending or descending order for a given column before moving on to the next column.
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
Filtering
- Case insensitive filtering will display rows if any text in any cell matches the filter term
- Use simple literal full or partial string matches
- Separate multiple filter terms with a space. Any order may be used (i. e. a b c and c b a are equivalent )
- Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
- Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")
Sorting
- Generally, the default sort order for tables is set to be first column ascending; however, specific tables may set a different default sort order.
- Click on any column header arrows to sort by that column
- Hold down the Shift key and click multiple columns to sort by more than one column. Be sure to set ascending or descending order for a given column before moving on to the next column.
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03123939 | Phase III | Tisagenlecleucel | Phase III B in Acute Lymphoblastic Leukemia | Completed | ITA | FRA | ESP | DEU | CAN | BEL | AUT | 2 |
| 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 |
| NCT03876769 | Phase II | Tisagenlecleucel | Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients (CASSIOPEIA) | Recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | 5 |
| NCT04094311 | Phase III | Tisagenlecleucel | Study of Out of Specification for Tisagenlecleucel | Recruiting | CAN | 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 |
| NCT03610724 | Phase II | Tisagenlecleucel | Phase II Open Label Trial to Determine Safety & Efficacy of Tisagenlecleucel in Pediatric Non-Hodgkin Lymphoma Patients (BIANCA) | Completed | USA | ITA | GBR | FRA | ESP | DEU | CAN | AUT | AUS | 5 |
| 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 |
| NCT03568461 | Phase II | Tisagenlecleucel | Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma (ELARA) | Active, not recruiting | USA | ITA | GBR | FRA | ESP | DEU | BEL | AUT | AUS | 3 |
| 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 |
| NCT04134117 | Phase I | Tisagenlecleucel | Tisagenlecleucel In Primary CNS Lymphoma | Unknown status | 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 | ESP | AUS | 2 |
| NCT02445248 | Phase II | Tisagenlecleucel | Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients (JULIET) | Completed | USA | ITA | FRA | DEU | CAN | AUT | AUS | 3 |
CKB BOOST