Phase II Open Label Trial to Determine Safety & Efficacy of Tisagenlecleucel in Pediatric Non-Hodgkin Lymphoma Patients
Model scores of the 29,894 trials active now.
Model score 20% for any early termination, 8% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 22% of the time (1,598 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-04-26, after 2019-02-15 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2023-04-26. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Sponsor's past termination rate: 15.1% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: leukemiacellchemotherapyprimarysubjects
Phrases that lowered it: lymphomaand safetyefficacy andsafety ofhodgkin -
Has a data monitoring committee: Yes (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 161 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 28.1% (raises risk) · Drug's FDA history
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Design: single group (raises risk) · Design
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Keywords listed: 20 (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Minimum age: not given (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Number of arms: 1 (raises risk) · Design
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Collaborators: 0 (raises risk) · Design
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Drug's FAERS reports marked serious: 92.8% (raises risk) · Drug's FDA history
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 2
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 20 (typical: 1)
Who can join
- Minimum age
- not given (typical: 18)
- Maximum age
- 25 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 1195 (typical: 32)
- Sponsor's past termination rate
- 15.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 161 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 416 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 274 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 28.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, infectious disease, immunology, hematology
- Drugs matched to FDA substances
- tisagenlecleucel
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Tisagenlecleucel in Adult Patients With Aggressive B-cell Non-Hodgkin Lymphoma NCT03570892 · started 2019 · scored riskier than 78% of active trials completed
- Partially HLA-Matched Irradiated Allogeneic Cellular Therapy After Reduced Intensity Total Body Irradiation NCT00996359 · started 2009 · scored riskier than 98% of active trials terminated
- Phase IIa Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Attached to TCRz and 4-Signaling Domains in Patients With Chemotherapy Relapsed or Refractory CD19+ Lymphomas NCT02030834 · started 2014 · scored riskier than 80% of active trials completed
- A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma NCT06256484 · started 2024 · scored riskier than 84% of active trials terminated
- Study Evaluating Brexucabtagene Autoleucel (KTE-X19) in Pediatric and Adolescent Participants With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma NCT02625480 · started 2016 · scored riskier than 93% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.