NCT07039383Completed
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 · Last updated 26 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 79 (actual)
- First submitted
- 18 Jun 2025
- Start date
- 1 Mar 2023
- Primary completion date
- 18 Jun 2024
- Lead sponsor
- Novartis Pharmaceuticals
- NCT number
- NCT07039383
What you commit to
- Study type: Observational
- Participants enrolled: 79
- From 1 Mar 2023 to the primary completion date, 18 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- Diagnosed with B-cell ALL.
- Infusion of tisa-cel happened since December 2020 and at least 1 year before the chart abstraction date.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novartis Coordinator of this site? Confirm its status | East Hanover | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.