1336GCC: Study of Erwinaze for Treatment of Acute Myeloid Leukemia (AML)
Model scores of the 29,894 trials active now.
Model score 20% for any early termination, 19% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 23% of the time (1,629 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
Completed on 2017-09-30, after 2014-04-30 start.
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 2017-09-30. 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: cellstempatients musteligibleleukemia
Phrases that lowered it: and safetydayopennervousmg -
Primary purpose: other (lowers risk) · Design
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Phase: 1 (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Responsible party: sponsor investigator (raises risk) · Design
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 27.1% (raises risk) · Drug's FDA history
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Disease area, cancer: Yes (raises risk) · Disease area
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Design: single group (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 95.8% (raises risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Sponsor's past trials: 0 (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Blinding: none (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
- 1 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- other (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 665 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 145 (typical: 412.5)
- Drug's FAERS reports marked serious
- 95.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 27.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, hematology
- Drugs matched to FDA substances
- asparaginase, asparaginase erwinia chrysanthemi
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
- A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy NCT01643408 · started 2012 · scored riskier than 91% of active trials completed
- Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) (IND 104224) NCT00928200 · started 2009 · scored riskier than 66% of active trials terminated
- Fludarabine, Cytarabine, and Pegcrisantaspase for the Treament of Relapsed or Refractory Leukemia NCT04526795 · started 2021 · scored riskier than 78% of active trials terminated
- AEG35156 in Combination With High-dose Cytarabine and Idarubicin in AML Following Failure of a Single Standard Dose Cytarabine Based Frontline Induction Regimen NCT01018069 · started 2009 · scored riskier than 96% of active trials terminated
- Pegaspargase and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia NCT01005914 · started 2009 · scored riskier than 91% 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.