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A Real-world Study of the Effectiveness of Tisagenlecleucel in Acute Lymphoblastic Leukemia Patients (KareALL)

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Novartis

Status

Completed

Conditions

Acute Lymphoblastic Leukemia

Study type

Observational

Funder types

Industry

Identifiers

NCT07039383
CCTL019BUS08

Details and patient eligibility

About

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.

Enrollment

79 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

79 participants in 1 patient group

Tisa-cel Cohort
Description:
Patients with R/R B-cell ALL who received tisa-cel infusions between December 2020 and September 2022.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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