Study to Investigate Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 Monoclonal Antibody (mAb) in Participants With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia
Model scores of the 29,894 trials active now.
Model score 18% 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 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 2015-04-28, after 2010-03-25 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 2015-04-28. 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: leukemiachronicclllymphocyticcell
Phrases that lowered it: patientsinvestigateinvestigatoraminotransferasesingle -
Phase: 1 (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Drug's FAERS reports with a death: 33.0% (raises risk) · Drug's FDA history
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Sponsor's past termination rate: 10.7% (raises risk) · Sponsor's track record
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Design: parallel (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: 40 (lowers risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Number of arms: 10 (lowers risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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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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Drug's FAERS reports marked serious: 91.3% (raises risk) · Drug's FDA history
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Drug's FAERS reports before start: 26541 (lowers risk) · Drug's FDA history
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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 (typical: 2)
- Number of arms
- 10 (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
- 3 (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
- 75 (typical: 32)
- Sponsor's past termination rate
- 10.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 40 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 8 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 26541 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 7713 (typical: 412.5)
- Drug's FAERS reports marked serious
- 91.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 33.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, immunology, hematology
- Drugs matched to FDA substances
- bendamustine, bortezomib, cal101, chlorambucil, everolimus, fludarabine, idelalisib, lenalidomide
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
- Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas NCT01282424 · started 2011 · scored riskier than 95% of active trials completed
- Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Idelalisib in Japanese Participants With Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphomas (iNHL) or Chronic Lymphocytic Leukemia (CLL) NCT02242045 · started 2014 · scored riskier than 35% of active trials completed
- Study of Idelalisib in Combination With BI 836826 in Participants With Chronic Lymphocytic Leukemia NCT02538614 · started 2015 · scored riskier than 88% of active trials terminated
- Trial of Idelalisib in Patients With Relapsed Diffuse Large B-cell Lymphoma NCT03576443 · started 2017 · scored riskier than 88% of active trials completed
- A Study of Idelalisib and Rituximab in Elderly Patients With Untreated CLL or SLL NCT01203930 · started 2010 · scored riskier than 90% 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.