Feasibility Study Of Adding Bortezomib to R-ICE Chemotherapy To Treat Relapsed/ Refractory Diffuse Large B-Cell Lymphoma
Model scores of the 29,894 trials active now.
Model score 15% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 23% of the time (1,629 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 2014-11-30, after 2010-11-30 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 2014-11-30. 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: subject hascellenrollmentchemotherapysubject is
Phrases that lowered it: patientsand safetydays beforegroupopen label -
Minimum age: 21 (lowers risk) · Who can join
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Phase: 1 (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 6.7% (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 23.8% (raises risk) · Drug's FDA history
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Disease area, cancer: Yes (raises risk) · Disease area
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Has a data monitoring committee: Yes (raises risk) · Design
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Design: single group (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 7 (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Drugs with FDA adverse-event history: 4 (lowers risk) · Drug's FDA history
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Maximum age: not given (raises risk) · Who can join
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Drug's FAERS reports before start: 33296 (lowers risk) · Drug's FDA history
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Collaborators: 1 (raises risk) · Design
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Drug's FAERS reports marked serious: 93.6% (raises risk) · Drug's FDA history
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Responsible party: sponsor (lowers risk) · Design
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Drug's FAERS reports in the prior 12 months: 6990 (lowers risk) · Drug's FDA history
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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 1
Who can join
- Minimum age
- 21 (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
- 15 (typical: 32)
- Sponsor's past termination rate
- 6.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 7 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 4 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 33296 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 6990 (typical: 412.5)
- Drug's FAERS reports marked serious
- 93.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 23.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, immunology, hematology
- Drugs matched to FDA substances
- bortezomib, carboplatin, etoposide, 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
- Phase II Randomized Study With R-DHAP +/- Bortezomib as Induction Therapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) Patients Eligible to Transplantation. BR-DHAP Versus R-DHAP. NCT01805557 · started 2013 · scored riskier than 62% of active trials completed
- Trial of Bendamustine, Bortezomib, and Rituximab in Patients With Previously Untreated Low Grade Lymphoma NCT01029730 · started 2010 · scored riskier than 73% of active trials completed
- Bortezomib, Cladribine, and Rituximab in Treating Patients With Advanced Mantle Cell Lymphoma or Indolent Lymphoma NCT00980395 · started 2009 · scored riskier than 95% of active trials completed
- Bendamustine Combined With Rituximab for Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma NCT00831597 · started 2008 · scored riskier than 91% of active trials completed
- Rituximab, Bendamustine Hydrochloride, and Lenalidomide in Treating Patients With Aggressive B-Cell Lymphoma NCT00987493 · started 2009 · scored riskier than 94% 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.