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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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Novartis
Coordinator of this site? Confirm its status
East HanoverUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.