Study to Evaluate Adverse Events and Movement of Lemzoparlimab in Body When Used Intravenously (IV) With Azacitidine Subcutaneously or IV and Venetoclax Orally in Participants With Acute Myeloid Leukemia and With Azacitidine With or Without Venetoclax in Participants With Myelodysplastic Syndrome
Model scores of the 29,894 trials active now.
Model score 20% for any early termination, 2% 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 (1,938 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2023-05-09, after 2021-06-25 start.
Reason given by the sponsor: “business”
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 2023-05-09. 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
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: cellchemotherapyleukemiacarcinomamarrow
Phrases that lowered it: participantsaccording20participantblood -
Sponsor's past termination rate: 16.1% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 1 (lowers risk) · Design
-
Drug's FAERS reports with a death: 37.1% (raises risk) · Drug's FDA history
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 90 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: 95.0% (raises risk) · Drug's FDA history
-
Minimum age: 18 (raises risk) · Who can join
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
-
Has a data monitoring committee: No (lowers risk) · Design
-
Sponsor's past trials: 236 (lowers risk) · Sponsor's track record
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Responsible party: sponsor (lowers risk) · Design
-
Drug's FAERS reports in the prior 12 months: 7708 (lowers risk) · Drug's FDA history
-
Design: sequential (raises risk) · Design
-
Maximum age: not given (raises risk) · Who can join
-
Number of arms: 7 (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 (typical: 2)
- Number of arms
- 7 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- sequential (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 12 (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
- industry (typical: academic or other)
- Sponsor's past trials
- 236 (typical: 32)
- Sponsor's past termination rate
- 16.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 90 (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
- 35612 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 7708 (typical: 412.5)
- Drug's FAERS reports marked serious
- 95.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 37.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, hematology
- Drugs matched to FDA substances
- azacitidine, lemzoparlimab, venetoclax
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
- CD8 Depleted, Non-engrafting, HLA Mismatched Unrelated Infusion With MDS and Secondary AML NCT04620681 · started 2021 · scored riskier than 93% of active trials completed
- A Biomarker-Directed Phase 2 Trial of Tamibarotene (SY-1425) in Participants With Acute Myeloid Leukemia or Myelodysplastic Syndrome NCT02807558 · started 2016 · scored riskier than 75% of active trials completed
- Vorinostat and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia NCT00673153 · started 2008 · scored riskier than 68% of active trials terminated
- A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable to Receive Intensive Chemotherapy NCT04266795 · started 2020 · scored riskier than 73% 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
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.