Phase I/II - Brentuximab/5-Azacytidine in Acute Myeloid Leukemia (AML)
Model scores of the 29,894 trials active now.
Model score 25% for any early termination, 18% 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 (851 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 2016-08-31, after 2014-04-30 start.
Reason given by the sponsor: “enrollment”
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 2016-08-31. 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: patientsgvhdpotentialallogeneictransplant
Phrases that lowered it: relapsedsafety ofdrugfirst doserefractory -
Sponsor's past termination rate: 28.9% (raises risk) · Sponsor's track record
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Phase: 1/2 (raises risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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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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Trials the sponsor started in the prior 2 years: 159 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 48.4% (raises risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 98.8% (raises risk) · Drug's FDA history
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Sponsor's past trials: 460 (lowers risk) · Sponsor's track record
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Blinding: none (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Collaborators: 1 (raises risk) · Design
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Responsible party: sponsor (lowers 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
- 1/2 (typical: 2)
- Number of arms
- 2
- Allocation
- non randomized (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
- 18 (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
- 460 (typical: 32)
- Sponsor's past termination rate
- 28.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 159 (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
- 4776 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1152 (typical: 412.5)
- Drug's FAERS reports marked serious
- 98.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 48.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, hematology
- Drugs matched to FDA substances
- azacitidine, brentuximab vedotin
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
- Brentuximab Vedotin + Re-induction Chemotherapy for AML NCT01830777 · started 2013 · scored riskier than 89% of active trials completed
- Brentuximab Vedotin Prevention of (GVHD) After Unrelated Allogeneic Stem Cell Transplantation NCT01700751 · started 2013 · scored riskier than 99% of active trials completed
- BV-CHEP Chemotherapy for Adult T-cell Leukemia or Lymphoma NCT03264131 · started 2018 · scored riskier than 96% of active trials completed
- A Phase II Study of Single Agent Brentuximab Vedotin in Relapsed/Refractory CD30 Low (<10%) Mature T Cell Lymphoma (TCL) NCT02588651 · started 2016 · scored riskier than 98% of active trials completed
- Brentuximab Vedotin in Patients With Relapsed or Refractory EBV-and CD30-positive Lymphomas NCT02388490 · started 2016 · scored riskier than 56% 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.