Identifying Prognostic Factors in Frontline FCR for Patients With Chronic Lymphocytic Leukemia (CLL)
Model scores of the 29,894 trials active now.
Model score 32% for any early termination, 25% 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 (3,728 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 2020-07-22, after 2008-08-13 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 2020-07-22. 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: leukemiafunctionstagepatients mustcancer
Phrases that lowered it: patientsdisordersingleaccordinggroup -
Sponsor's past termination rate: 21.7% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 194 (lowers 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 with a death: 24.9% (raises risk) · Drug's FDA history
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Design: single group (raises risk) · Design
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Drug's FAERS reports marked serious: 95.0% (raises risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Maximum age: not given (raises risk) · Who can join
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Number of arms: 1 (raises risk) · Design
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Keywords listed: 6 (lowers risk) · Design
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Blinding: none (raises risk) · Design
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Minimum age: 16 (raises risk) · Who can join
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Sponsor's past trials: 152 (lowers risk) · Sponsor's track record
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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
- 2
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (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
- 0
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 16 (typical: 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
- 152 (typical: 32)
- Sponsor's past termination rate
- 21.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 194 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 14185 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4100 (typical: 412.5)
- Drug's FAERS reports marked serious
- 95.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 24.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, immunology, hematology
- Drugs matched to FDA substances
- cyclophosphamide, fludarabine, rituximab
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
- Early or Delayed Fludarabine and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia NCT00513747 · started 2008 · scored riskier than 57% of active trials terminated
- Alemtuzumab + Rituximab Consolidation in CLL NCT00771602 · started 2008 · scored riskier than 89% of active trials terminated
- FCR or BR in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia NCT00769522 · started 2008 · scored riskier than 97% of active trials completed
- Phase II Study of High-Dose Rituximab in High-Risk Chronic Lymphocytic Leukemia Patients in Suboptimal Response After Induction Immunochemotherapy NCT01625741 · started 2012 · scored riskier than 88% of active trials terminated
- Fludarabine, Bendamustine, and Rituximab (FBR) for Relapsed Chronic Lymphocytic Leukemia (CLL) NCT01096992 · started 2010 · scored riskier than 99% 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.