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NCT07039383 · ClinicalTrials.gov registry record
A Real-world Study of the Effectiveness of Tisagenlecleucel in Acute Lymphoblastic Leukemia Patients
A clinical trial, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- 79
- Enrollment target
NCT07039383: Completed study, sponsored by Novartis Pharmaceuticals.
NCT07039383 is a clinical trial that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 79 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07039383 has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- 79 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2023-03-01 |
| Est. Completion | 2024-06-18 |
What the finished NCT07039383 record still lists
NCT07039383 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 79 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT07039383 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07039383 about?
NCT07039383 is a clinical study titled "A Real-world Study of the Effectiveness of Tisagenlecleucel in Acute Lymphoblastic Leukemia Patients". 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 i...
What is the current status of trial NCT07039383?
This trial is currently completed. The enrollment target is 79 participants. The study started on 2023-03-01. Estimated completion is 2024-06-18.
Who is sponsoring clinical trial NCT07039383?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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