A Study to Compare the Efficacy and Safety of a Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/ Bendamustine And Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL (17P) or TP53 Mutation
Model scores of the 29,894 trials active now.
Model score 10% for any early termination, 1% 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 (927 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2025-03-19, after 2020-05-28 start.
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 2025-03-19. 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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Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
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Has a data monitoring committee: not given (lowers risk) · Design
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: leukemiapriormutationcelltherapy
Phrases that lowered it: participantsparticipantand safetyefficacy andsafety of -
Disease area, cancer: Yes (raises risk) · Disease area
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Trials the sponsor started in the prior 2 years: 101 (lowers risk) · Sponsor's track record
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Sponsor's past termination rate: 9.5% (raises 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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Drug's FAERS reports before start: 260524 (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Sponsor's past trials: 1145 (raises risk) · Sponsor's track record
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Drug's FAERS reports in the prior 12 months: 50892 (lowers risk) · Drug's FDA history
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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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- not given (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
- 1145 (typical: 32)
- Sponsor's past termination rate
- 9.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 101 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 6 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 260524 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 50892 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 21.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, immunology, hematology
- Drugs matched to FDA substances
- bendamustine, cyclophosphamide, fludarabine, obinutuzumab, rituximab, venetoclax
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
- Venetoclax and Ibrutinib in Patients With Relapsed/Refractory CLL or SLL NCT03045328 · started 2017 · scored riskier than 96% of active trials completed
- A Study of Obinutuzumab + Bendamustine (BG) in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) NCT02320487 · started 2015 · scored riskier than 30% of active trials completed
- Bendamustine/Rituximab Followed by Venetoclax and Rituximab for Treatment of Chronic Lymphocytic Leukemia NCT03609593 · started 2018 · scored riskier than 98% of active trials completed
- Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia NCT02242942 · started 2014 · scored riskier than 10% of active trials completed
- A Safety and Efficacy Study of Obinutuzumab Alone or in Combination With Chemotherapy in Participants With Chronic Lymphocytic Leukemia NCT01905943 · started 2013 · scored riskier than 17% 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.