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

NCT ID: NCT07039383

Last Updated: 2025-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-06-18

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Lymphoblastic Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Tisa-cel Cohort

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

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis

East Hanover, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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CCTL019BUS08

Identifier Type: -

Identifier Source: org_study_id

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