Activity, Safety and Pharmacokinetics in Pediatric Subjects With Moderate and Severe Chronic Graft vs. Host Disease After Allogeneic Stem Cell Transplant
Model scores of the 29,894 trials active now.
Model score 20% for any early termination, 7% 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 2024-08-26, after 2020-05-20 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 2024-08-26. 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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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: cellsmalluncontrolleddonortherapy
Phrases that lowered it: singlepharmacokineticsparticipantkgparticipants -
Sponsor's past termination rate: 15.2% (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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Drug's FAERS reports marked serious: 58.1% (lowers risk) · Drug's FDA history
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Sponsor's past trials: 1312 (raises risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 141 (lowers risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Has a data monitoring committee: Yes (raises risk) · Design
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Maximum age: 17 (raises risk) · Who can join
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Minimum age: 0.08 (lowers risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 18.5% (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 7459 (lowers risk) · Drug's FDA history
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Disease area, respiratory: Yes (raises risk) · Disease area
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Collaborators: 0 (raises risk) · Design
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
- 8 (typical: 1)
Who can join
- Minimum age
- 0.08 (typical: 18)
- Maximum age
- 17 (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
- 1312 (typical: 32)
- Sponsor's past termination rate
- 15.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 141 (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
- 34453 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 7459 (typical: 412.5)
- Drug's FAERS reports marked serious
- 58.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 18.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, respiratory, immunology, hematology
- Drugs matched to FDA substances
- ruxolitinib
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
- Upfront Ruxolitinib for Chronic Graft-vs-host Disease NCT06695507 · started 2025 · scored riskier than 71% of active trials terminated
- Study of Pharmacokinetics, Activity and Safety of Ruxolitinib in Pediatric Patients With Grade II-IV Acute Graft vs. Host Disease NCT03491215 · started 2019 · scored riskier than 77% of active trials completed
- A Study of Ruxolitinib in Combination With Corticosteroids for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease (REACH-1) NCT02953678 · started 2016 · scored riskier than 87% of active trials completed
- Study of Ruxolitinib in Sclerotic Chronic Graft-Versus-Host Disease After Failure of Systemic Glucocorticoids NCT03616184 · started 2018 · scored riskier than 84% of active trials completed
- Study of Ruxolitinib for Acute and Chronic Graft Versus Host Disease NCT05121142 · started 2021 · scored riskier than 78% 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.