Efficacy/Safety Study of R-CHOP vs Bortezomib-R-CAP for Young Patients With Diffuse Large B-cell Lymphoma With Poor IPI.

NCT01848132 on ClinicalTrials.gov Phase 2 Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea (academic or other) Started 2013-10-03 Completed

Riskier than 57% of active trials

Model scores of the 29,894 trials active now.

Model score 18% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (3,728 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 2018-08-31, after 2013-10-03 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 2018-08-31. 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
Accepts healthy volunteers: No (raises risk) · Who can join
Disease area, cancer: Yes (raises risk) · Disease area
Phase: 2 (raises risk) · Design
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: cellcarcinomadefined asuncontrolledventricular
Phrases that lowered it: positivedrugshepatitishcvimpairment
Design: parallel (raises risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Drug's FAERS reports in the prior 12 months: 35902 (lowers risk) · Drug's FDA history
Maximum age: 70 (lowers risk) · Who can join
Drug's FAERS reports before start: 169727 (lowers risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
Number of arms: 2 (raises risk) · Design
Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
Collaborators: 1 (raises risk) · Design
Sponsor's past trials: 4 (lowers risk) · Sponsor's track record

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: 2 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 70 (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 4 (typical: 32)
Sponsor's past termination rate: 25% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 1 (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: 169727 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 35902 (typical: 412.5)
Drug's FAERS reports marked serious: 88.6% (typical: 85.6%)
Drug's FAERS reports with a death: 21.3% (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

RHCACD20MA (HS006) Combined With CHOP (Hi-CHOP) in Patients With Previously Untreated Diffuse Large B-cell Lymphoma NCT03485118 · started 2016 · scored riskier than 22% of active trials completed
Phase II Randomized Study With R-DHAP +/- Bortezomib as Induction Therapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) Patients Eligible to Transplantation. BR-DHAP Versus R-DHAP. NCT01805557 · started 2013 · scored riskier than 62% of active trials completed
Intensified 1st Cycle Rituximab Plus 8th Cycles of R-CHOP Chemotherapy in Patients With Advanced or Bulky CD20+ Diffuse Large B-cell Lymphoma (DLBCL) NCT01054781 · started 2009 · scored riskier than 33% of active trials completed
Therapy for Patients With Untreated Age-Adjusted International Prognostic Index Low-Intermediate Risk, High-Intermediate Risk, or High Risk Diffuse Large B Cell Lymphoma NCT00712582 · started 2008 · scored riskier than 68% of active trials completed
R-CHOP14 or R-CHOP21 &Consolidation PET-Oriented Radiotherapy (RT) in DLBCL Patients NCT03364439 · started 2012 · scored riskier than 28% 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.