A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma

NCT03677141 on ClinicalTrials.gov Phase 1/2 Hoffmann-La Roche (industry) Started 2019-03-08 Completed

Riskier than 20% 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 29% of the time (655 trials).

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

How it ended

Completed on 2023-10-12, after 2019-03-08 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 2023-10-12. 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

Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: cellphase iicancerdiseasetransplantation
Phrases that lowered it: participantslymphomarelapsedpharmacokineticsor refractory
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1/2 (raises risk) · Design
Has a data monitoring committee: not given (lowers risk) · Design
Sponsor's past termination rate: 9.2% (raises risk) · Sponsor's track record
Drug's FAERS reports with a death: 15.4% (lowers risk) · Drug's FDA history
Disease area, cancer: Yes (raises risk) · Disease area
Trials the sponsor started in the prior 2 years: 124 (lowers risk) · Sponsor's track record
Sponsor's past trials: 1060 (raises risk) · Sponsor's track record
Number of arms: 6 (lowers risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Design: parallel (raises risk) · Design
Drug's FAERS reports before start: 446681 (lowers risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
Maximum age: not given (raises risk) · Who can join
Keywords listed: 0 (lowers risk) · Design
Drug's FAERS reports marked serious: 82.9% (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: 1/2 (typical: 2)
Number of arms: 6 (typical: 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: 1060 (typical: 32)
Sponsor's past termination rate: 9.2% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 124 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 7 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 446681 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 85128 (typical: 412.5)
Drug's FAERS reports marked serious: 82.9% (typical: 85.6%)
Drug's FAERS reports with a death: 15.4% (typical: 15.9%)

Disease area and drugs

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

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 of Polatuzumab Vedotin in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Participants With B-Cell Non-Hodgkin's Lymphoma NCT01992653 · started 2013 · 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
Trial of Mosunetuzumab (BTCT4465A) as Consolidation Therapy in Participants With Diffuse Large B-Cell Lymphoma Following First-Line Immunochemotherapy and as Monotherapy or in Combination With Polatuzumab Vedotin in Elderly/Unfit Participants With Previously Untreated Diffuse Large B-Cell Lymphoma NCT03677154 · started 2019 · scored riskier than 27% 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

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.