A Study to Evaluate the Efficacy and Safety of Polatuzumab Vedotin in Combination With Bendamustine and Rituximab Compared With Bendamustine and Rituximab Alone in Chinese Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL).

NCT04236141 on ClinicalTrials.gov Phase 3 Hoffmann-La Roche (industry) Started 2020-07-10 Terminated

Riskier than 14% of active trials

Model scores of the 29,894 trials active now.

Model score 9% 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

Terminated on 2022-02-07, after 2020-07-10 start.

Reason given by the sponsor: “business”

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 2022-02-07. 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

Phase: 3 (lowers risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: cellchemotherapycombination within combinationtransplant
Phrases that lowered it: participantsand safetyefficacy andsafety ofthe efficacy
Has a data monitoring committee: not given (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 103 (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 17.2% (lowers risk) · Drug's FDA history
Disease area, cancer: Yes (raises risk) · Disease area
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports before start: 113858 (lowers risk) · Drug's FDA history
Sponsor's past termination rate: 9.7% (raises risk) · Sponsor's track record
Sponsor's past trials: 1150 (raises risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Design: parallel (raises risk) · Design
Blinding: quadruple (lowers risk) · Design
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports in the prior 12 months: 24254 (lowers risk) · Drug's FDA history
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: quadruple (typical: 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: 1150 (typical: 32)
Sponsor's past termination rate: 9.7% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 103 (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: 113858 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 24254 (typical: 412.5)
Drug's FAERS reports marked serious: 90.6% (typical: 85.6%)
Drug's FAERS reports with a death: 17.2% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, immunology, hematology
Drugs matched to FDA substances: bendamustine, polatuzumab vedotin, 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

A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma NCT04182204 · started 2020 · scored riskier than 14% of active trials completed
A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma NCT02257567 · started 2014 · scored riskier than 22% of active trials completed
Polatuzumab Vedotin Plus Rituximab, Ifosfamide, Carboplatin and Etoposide (Pola-R-ICE) Versus R-ICE Alone in Second Line Treatment of Diffuse Large B-cell Lymphoma (DLBCL) NCT04833114 · started 2021 · scored riskier than 69% of active trials completed
A Study Comparing SIBP-02 and Rituximab Combination With CHOP in Previously Untreated Subjects With CD20+ DLBCL NCT04361279 · started 2019 · scored riskier than 23% of active trials completed
A Study of Glofitamab in Combination With Rituximab or Obinutuzumab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (CHP) in Participants With Non-Hodgkin Lymphomas or With DLBCL NCT03467373 · started 2018 · scored riskier than 14% 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.