Actively Recruiting
A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy
Led by Novartis Pharmaceuticals · Updated on 2026-04-14
30
Participants Needed
3
Research Sites
701 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study aims to provide an adequate procedural framework to support and facilitate collection of existing participant samples from patients who were diagnosed with secondary malignancy of T-cell origin any time after tisagenlecleucel treatment for testing of muCAR19 transgene and RCL, as well as additional analyses as warranted. Formal testing of existing tumor tissue and/or blood DNA will assess a potential role of tisagenlecleucel in the development/oncogenesis of secondary malignancy of T-cell origin.
CONDITIONS
Official Title
A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Prior treatment with tisagenlecleucel in clinical trial or commercial setting
- Confirmed diagnosis of secondary malignancy of T-cell origin by pathology report or clinical confirmation
- Availability of existing tissue, bone marrow, blood, or DNA samples containing malignant T-cells for testing
- Signed informed consent or appropriate consent by family or representative if participant deceased
You will not qualify if you...
- Currently enrolled in Novartis-sponsored interventional or long-term follow-up clinical trials
- No available samples of secondary T-cell malignancy tissue, blood, bone marrow, or DNA for testing
- Inability to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Novartis Investigative Site
Kurume, Fukuoka, Japan, 830-8543
Actively Recruiting
2
Novartis Investigative Site
Osaka, Osaka, Japan, 5418567
Actively Recruiting
3
Novartis Investigative Site
Bunkyo Ku, Tokyo, Japan, 1138677
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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