A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax in Combination With Polatuzumab Vedotin Plus Rituximab (R) and Cyclophosphamide, Doxorubicin, Prednisone (CHP) in Participants With Untreated BCL-2 Immunohistochemistry (IHC)-Positive Diffuse Large B-Cell Lymphoma (DLBCL)

NCT04790903 on ClinicalTrials.gov Phase 1 Hoffmann-La Roche (industry) Started 2021-07-02 Terminated

Riskier than 19% of active trials

Model scores of the 29,894 trials active now.

Model score 11% 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 (1,938 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Terminated on 2024-05-21, after 2021-07-02 start.

Reason given by the sponsor: “safety”

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 2024-05-21. 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: 1 (lowers risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Has a data monitoring committee: not given (lowers risk) · Design
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: cellmultiplemeasurableuntreatedgrade
Phrases that lowered it: screeningpharmacokineticspositiverefrain fromprior to
Drug's FAERS reports with a death: 15.1% (lowers risk) · Drug's FDA history
Sponsor's past termination rate: 9.9% (raises risk) · Sponsor's track record
Disease area, cancer: Yes (raises risk) · Disease area
Trials the sponsor started in the prior 2 years: 127 (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports before start: 686778 (lowers risk) · Drug's FDA history
Design: sequential (raises risk) · Design
Sponsor's past trials: 1196 (raises risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports in the prior 12 months: 105906 (lowers risk) · Drug's FDA history
Drugs with FDA adverse-event history: 6 (lowers risk) · Drug's FDA history
Drug's FAERS reports marked serious: 85.4% (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: 1 (typical: 2)
Number of arms: 2
Allocation: non randomized (typical: randomized)
Design: sequential (typical: 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: 1196 (typical: 32)
Sponsor's past termination rate: 9.9%
Trials the sponsor started in the prior 2 years: 127 (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: 686778 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 105906 (typical: 412.5)
Drug's FAERS reports marked serious: 85.4% (typical: 85.6%)
Drug's FAERS reports with a death: 15.1% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, immunology, hematology
Drugs matched to FDA substances: cyclophosphamide, doxorubicin, polatuzumab vedotin, prednisone, 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

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
A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma NCT03274492 · started 2017 · scored riskier than 19% of active trials completed
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 Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax Combined With Chemotherapy in Participants With B-Cell Non-Hodgkin's Lymphoma (NHL) and DLBCL NCT02055820 · started 2013 · scored riskier than 30% of active trials completed
Study of Venetoclax Plus DA-EPOCH-R for the Treatment of Aggressive B-Cell Lymphomas NCT03036904 · started 2017 · scored riskier than 61% 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.