In-vivo Regulatory T Cell Enhancement With Cyclophosphamide and Sirolimus
Model scores of the 29,894 trials active now.
Model score 28% for any early termination, 13% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 30% of the time (37 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Terminated on 2012-07-31, after 2011-08-31 start.
Reason given by the sponsor: “safety”
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2012-07-31. 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: patients mustcellacuteazacitidinereceived
Phrases that lowered it: definedcorticosteroidsinvestigatorsexacerbationusing -
Sponsor's past termination rate: 25% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 1/2 (raises risk) · Design
-
Drug's FAERS reports with a death: 27.5% (raises risk) · Drug's FDA history
-
Drug's FAERS reports marked serious: 96.6% (raises risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
-
Design: parallel (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Number of arms: 3 (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
-
Collaborators: 0 (raises risk) · Design
-
Maximum age: 70 (lowers risk) · Who can join
-
Drugs with FDA adverse-event history: 3 (lowers 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
- 1/2 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 70 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 4 (typical: 32)
- Sponsor's past termination rate
- 25% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 9 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 22516 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 5981 (typical: 412.5)
- Drug's FAERS reports marked serious
- 96.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 27.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- immunology
- Drugs matched to FDA substances
- azacitidine, cyclophosphamide, sirolimus
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
- Multiple Donor Treg DLI for Severe Refractory Chronic GVHD NCT02749084 · started 2016 · scored riskier than 88% of active trials completed
- A Study of Rituximab Combined With Prednisone for the Initial Treatment of Chronic Graft Versus Host Disease (cGVHD) NCT01066598 · started 2010 · scored riskier than 99% of active trials terminated
- Study of First Line Treatment of Chronic Graft Versus Host Disease With the Association of Ciclosporine, Corticosteroids and Rituximab (Protocol R-GVHD) NCT01135641 · started 2010 · scored riskier than 79% of active trials completed
- Acute Graft-versus-Host Disease Treatment (BMT CTN 0802) NCT01002742 · started 2010 · scored riskier than 95% of active trials completed
- Phase II Study of Tocilizumab for Patients With Glucocorticoid-refractory Acute GVHD After Allogeneic Hematopoetic Stem Cell Transplant (HSCT) NCT01757197 · started 2013 · scored riskier than 95% of active trials terminated
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.