Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (H-R MDS)
Model scores of the 29,894 trials active now.
Model score 26% for any early termination, 12% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (3,728 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 2012-08-31, after 2009-04-30 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 2012-08-31. 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: highleukemiariskmg dlstable
Phrases that lowered it: judged14daysparticipantsdose -
Sponsor's past termination rate: 24.0% (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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Trials the sponsor started in the prior 2 years: 165 (lowers risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Drug's FAERS reports with a death: 36.7% (raises risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
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Number of arms: 1 (raises risk) · Design
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Drug's FAERS reports marked serious: 97.8% (raises risk) · Drug's FDA history
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Sponsor's past trials: 179 (lowers risk) · Sponsor's track record
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Allocation: not applicable (raises risk) · Design
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Collaborators: 1 (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Responsible party: sponsor (lowers risk) · Design
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Minimum age: 16 (raises risk) · Who can join
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
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 9 (typical: 1)
Who can join
- Minimum age
- 16 (typical: 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
- 179 (typical: 32)
- Sponsor's past termination rate
- 24.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 165 (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
- 971 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 136 (typical: 412.5)
- Drug's FAERS reports marked serious
- 97.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 36.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, hematology
- Drugs matched to FDA substances
- decitabine, gemtuzumab ozogamicin
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
- Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia and High-risk Myelodysplastic Syndrome NCT00968071 · started 2008 · scored riskier than 38% of active trials completed
- Magrolimab, Azacitidine, and Venetoclax for the Treatment of Acute Myeloid Leukemia NCT04435691 · started 2020 · scored riskier than 88% of active trials terminated
- Fostamatinib for the Treatment of Lower-risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia Who Have Failed Therapy With Hypomethylating Agents NCT05030675 · started 2021 · scored riskier than 76% of active trials completed
- Phase II Study of the Combination of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin (MEGO) for Patients With Acute Myeloid Leukemia Refractory to Initial Standard Induction Therapy NCT03839446 · started 2019 · scored riskier than 79% of active trials completed
- CD8 Depleted, Non-engrafting, HLA Mismatched Unrelated Infusion With MDS and Secondary AML NCT04620681 · started 2021 · 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.