Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin's Lymphoma (NHL)
Model scores of the 29,894 trials active now.
Model score 17% for any early termination, 5% 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 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 2011-10-31, after 2010-05-31 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 2011-10-31. 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: patient hasheartentrykeyradiation
Phrases that lowered it: lymphomathe efficacyefficacy andand safetyopen label -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Sponsor's past termination rate: 13.0% (raises risk) · Sponsor's track record
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Disease area, cancer: Yes (raises risk) · Disease area
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Design: single group (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 19.8% (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Maximum age: not given (raises risk) · Who can join
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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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Drug's FAERS reports marked serious: 99.5% (raises risk) · Drug's FDA history
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Number of arms: 1 (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 16 (raises risk) · Sponsor's track record
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Drug's FAERS reports before start: 182 (raises risk) · Drug's FDA history
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Responsible party: sponsor (lowers risk) · Design
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Collaborators: 0 (raises 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
- 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
- 46 (typical: 32)
- Sponsor's past termination rate
- 13.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 16 (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
- 182 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 102 (typical: 412.5)
- Drug's FAERS reports marked serious
- 99.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 19.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, immunology, hematology
- Drugs matched to FDA substances
- bendamustine, ofatumumab
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
- Ofatumumab and Bendamustine Followed by Maintenance Ofatumumab for Rituximab Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL) NCT01294579 · started 2011 · scored riskier than 81% of active trials completed
- Ofatumumab and Bortezomib for Patients With Low-grade B-cell Non-hodgkin Lymphoma That Relapse After Rituximab NCT01119794 · started 2010 · scored riskier than 82% of active trials terminated
- Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy NCT01077518 · started 2010 · scored riskier than 47% of active trials terminated
- Drug-drug Interaction Study of Ofatumumab With Bendamustine in Subjects With Indolent B-cell Non-Hodgkin's Lymphoma NCT01691807 · started 2013 · scored riskier than 73% of active trials completed
- Ofatumumab for Initial Systemic Treatment of Indolent B-cell Lymphoma NCT01239394 · started 2010 · scored riskier than 90% 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.