Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

NCT01040871 on ClinicalTrials.gov Phase 2 Millennium Pharmaceuticals, Inc. (industry) Started 2010-01-31 Completed

Riskier than 71% of active trials

Model scores of the 29,894 trials active now.

Model score 20% for any early termination, 6% 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 2012-08-31, after 2010-01-31 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 2012-08-31. 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

Sponsor's past termination rate: 25% (raises risk) · Sponsor's track record
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: cellchemotherapyactivegradeuncontrolled
Phrases that lowered it: malelabelrandomized opensubjectsand safety
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 2 (raises risk) · Design
Disease area, cancer: Yes (raises risk) · Disease area
Minimum age: 18 (raises risk) · Who can join
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports in the prior 12 months: 16179 (lowers risk) · Drug's FDA history
Design: parallel (raises risk) · Design
Trials the sponsor started in the prior 2 years: 28 (lowers risk) · Sponsor's track record
Maximum age: not given (raises risk) · Who can join
Drug's FAERS reports with a death: 20.1% (lowers risk) · Drug's FDA history
Drug's FAERS reports before start: 66496 (lowers risk) · Drug's FDA history
Has a data monitoring committee: No (lowers risk) · Design
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports marked serious: 86.6% (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: 2
Number of arms: 2
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 1 (typical: 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: 12 (typical: 32)
Sponsor's past termination rate: 25% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 28 (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: 66496 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 16179 (typical: 412.5)
Drug's FAERS reports marked serious: 86.6% (typical: 85.6%)
Drug's FAERS reports with a death: 20.1% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, immunology, hematology
Drugs matched to FDA substances: bortezomib, cyclophosphamide, doxorubicin, prednisone, rituximab, 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

Study to Assess the Effectiveness of RCHOP With or Without VELCADE in Previously Untreated Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma Patients NCT00931918 · started 2009 · scored riskier than 76% of active trials completed
A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA) NCT01287741 · started 2011 · scored riskier than 9% of active trials terminated
Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab NCT00850499 · started 2009 · scored riskier than 68% of active trials terminated
Study of Rituximab and Bendamustine With or Without Brentuximab Vedotin for CD30 Positive Diffuse Large B-cell Lymphoma NCT02594163 · started 2015 · scored riskier than 61% of active trials terminated
A Study of Obinutuzumab [RO5072759 (GA101)] in Combination With CHOP Chemotherapy in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma (GATHER) NCT01414855 · started 2011 · scored riskier than 22% 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.