Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)
Model scores of the 29,894 trials active now.
Model score 22% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (927 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2024-10-02, after 2020-06-08 start.
Reason given by the sponsor: “efficacy”
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 2024-10-02. 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: leukemiachemotherapyrandomizationhighcell
Phrases that lowered it: participantsinvestigatoraccordingclinicaladult -
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
-
Maximum age: 100 (lowers risk) · Who can join
-
Drug's FAERS reports with a death: 43.9% (raises risk) · Drug's FDA history
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Phase: 3 (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
-
Blinding: triple (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 145 (lowers risk) · Sponsor's track record
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Sponsor's past trials: 1315 (raises risk) · Sponsor's track record
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Disease area, cancer: Yes (raises risk) · Disease area
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Drug's FAERS reports marked serious: 97.6% (raises risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Primary purpose: treatment (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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 12 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 100 (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
- 1315 (typical: 32)
- Sponsor's past termination rate
- 15.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 145 (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
- 13443 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1876 (typical: 412.5)
- Drug's FAERS reports marked serious
- 97.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 43.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, hematology
- Drugs matched to FDA substances
- azacitidine, sabatolimab
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 MBG453 in Combination With Hypomethylating Agents in Subjects With IPSS-R Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS). NCT03946670 · started 2019 · scored riskier than 76% of active trials terminated
- STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS NCT04878432 · started 2022 · scored riskier than 77% of active trials terminated
- A Study of Sabatolimab in Combination With Azacitidine and Venetoclax in High or Very High Risk MDS Participants NCT04812548 · started 2021 · scored riskier than 80% of active trials terminated
- Phase Ib Study of Select Drug Combinations in Patients With Lower Risk MDS NCT04810611 · started 2021 · scored riskier than 44% of active trials terminated
- Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS) NCT04313881 · started 2020 · scored riskier than 96% 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.