Phase III Study of SyB L-0501 in Combination With Rituximab to Treat Recurrent/Relapsed Diffuse Large B-Cell Lymphoma

NCT03372837 on ClinicalTrials.gov Phase 3 SymBio Pharmaceuticals (industry) Started 2018-01-15 Completed

Riskier than 17% of active trials

Model scores of the 29,894 trials active now.

Model score 10% for any early termination, 2% 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

Completed on 2019-12-31, after 2018-01-15 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 2019-12-31. 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

Minimum age: 20 (lowers risk) · Who can join
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 3 (lowers risk) · Design
Disease area, cancer: Yes (raises risk) · Disease area
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: cellpatientcancerto determinestem
Phrases that lowered it: patients whopatients with20open labelcriteria patients
Design: single group (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Sponsor's past termination rate: 7.7% (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Drug's FAERS reports with a death: 20.1% (lowers risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
Number of arms: 1 (raises risk) · Design
Drug's FAERS reports before start: 56317 (lowers risk) · Drug's FDA history
Maximum age: not given (raises risk) · Who can join
Responsible party: sponsor (lowers risk) · Design

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: 1 (typical: 2)
Allocation: not applicable (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 1

Who can join

Minimum age: 20 (typical: 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: 13 (typical: 32)
Sponsor's past termination rate: 7.7% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 2 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 56317 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 12725 (typical: 412.5)
Drug's FAERS reports marked serious: 90.2% (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: 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

Study of SyB L-0501 in Combination With Rituximab to Treat Relapsed/Refractory Diffuse Large B-Cell Lymphoma NCT01118845 · started 2010 · scored riskier than 21% of active trials completed
A Phase I Clinical Trial of SyB L-0501 in Combination With Rituximab to Patients With Aggressive B-cell Non-Hodgkin's Lymphoma NCT00794638 · started 2008 · scored riskier than 11% 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
A Phase 1 Trial of OPB-111077 in Combination With Bendamustine and Rituximab in Patients With r/r DLBCL NCT04049825 · started 2019 · scored riskier than 8% of active trials completed
Bendamustine Combined With Rituximab for Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma NCT00831597 · started 2008 · scored riskier than 91% 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.