A Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With Umbralisib for Participants Previously Enrolled in Protocol UTX-TGR-304
Model scores of the 29,894 trials active now.
Model score 20% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 22% of the time (1,598 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2022-07-11, after 2016-01-07 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 2022-07-11. 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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Sponsor's past termination rate: 33.3% (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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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: leukemiaecogcombinationlymphomalymphocytic
Phrases that lowered it: participantslabelopenreceivein clinical -
Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
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Number of arms: 3 (lowers risk) · Design
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Drug's FAERS reports marked serious: 66.7% (lowers risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Design: parallel (raises risk) · Design
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Blinding: none (raises risk) · Design
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Sponsor's past trials: 3 (lowers 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
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
- 3 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (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
- 3 (typical: 32)
- Sponsor's past termination rate
- 33.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 6 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 3 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3 (typical: 412.5)
- Drug's FAERS reports marked serious
- 66.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, immunology, hematology
- Drugs matched to FDA substances
- ublituximab, umbralisib
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
- Extension Trial of Ublituximab and TGR-1202 in Combination or as Single Agents in Subjects Currently Receiving Treatment on Ublituximab and/or TGR-1202 Trials NCT03207256 · started 2017 · scored riskier than 98% of active trials terminated
- Evaluate the Efficacy and Safety of TGR-1202 in Participants With Chronic Lymphocytic Leukemia Who Are Intolerant to Prior Therapy NCT02742090 · started 2016 · scored riskier than 89% of active trials terminated
- Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia NCT02612311 · started 2015 · scored riskier than 72% of active trials terminated
- Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax Compared to Ublituximab in Combination With Umbralisib in Subjects With CLL (ULTRA-V) NCT03801525 · started 2019 · scored riskier than 68% of active trials terminated
- Study to Assess the Efficacy and Safety of Umbralisib in Participants With Non-Follicular Indolent Non-Hodgkin's Lymphoma NCT03364231 · started 2017 · scored riskier than 67% 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.