Clinical trial · Observational
A Real-world Study of the Effectiveness of Tisagenlecleucel in Acute Lymphoblastic Leukemia Patients
Kymriah Real-world Effectiveness in ALL (KareALL): a Retrospective Chart Review Study of Tisagenlecleucel-treated ALL Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This was a retrospective, cross-sectional, center-based chart review study that collected real-world data for relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL) patients receiving tisagenlecleucel (tisa-cel). Five centers in the United States were included for the study. The date of the initial tisa-cel infusion was defined as the index date. A baseline period from ALL diagnosis to the index date was used to capture patient characteristics including demographics, and disease and treatment history. The study period, defined as the period from tisa-cel infusion to the end of follow-up date, i.e. the last contact date on medical charts or death, whichever was earlier, was used to capture the clinical outcomes of tisa-cel among ALL patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Tisa-cel Cohort
- description
- Patients with R/R B-cell ALL who received tisa-cel infusions between December 2020 and September 2022.
Primary outcomes (1)
- measure
- Remission Rate
- timeFrame
- Month 1 and Month 3
- description
- Remission rate was defined as the best overall response as either complete remission (CR) or complete remission with incomplete blood count recovery (CRi) to tisa-cel. CR: \<5% blasts in bone marrow based on morphologic assessment, no evidence of extramedullary disease, full recovery of peripheral blood counts (platelets \> 100x10\^9/L, absolute neutrophil \> 1.0x10\^9/L, and circulating blasts \<1%), and blood transfusions independency (i.e., no transfusion or transfusion ≤7 days). CRi: \<5% blasts in bone marrow, no evidence of extramedullary disease, but without full recovery of peripheral blood counts with or without blood transfusions independency.
Secondary outcomes (43)
- measure
- Number of Patients per Demographic Category
- timeFrame
- Baseline
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion criteria: * Diagnosed with B-cell ALL. * Infusion of tisa-cel happened since December 2020 and at least 1 year before the chart abstraction date. Exclusion criteria: None.
References
Publications (0)
Data not yet available