Safety and Feasibility Study of Combination of State of Art Chemoimmunotherapy, Intensive Central Nervous System Prophylaxis and Scrotal Irradiation to Treat Primary Diffuse Large B-cell Lymphoma of Testis

NCT00945724 on ClinicalTrials.gov Phase 2 International Extranodal Lymphoma Study Group (IELSG) (academic or other) Started 2009-09-27 Completed

Riskier than 64% of active trials

Model scores of the 29,894 trials active now.

Model score 19% 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 16% of the time (1,198 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 2023-09-26, after 2009-09-27 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 2023-09-26. 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) (raises risk) · Wording Phrases that raised it: stagecellchemotherapycancerradiation
Phrases that lowered it: relevantthe studyparticipation in109months before
Sponsor's past termination rate: 25% (raises risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 2 (raises risk) · Design
Has a data monitoring committee: not given (lowers risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Design: single group (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports with a death: 17.6% (lowers risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Drug's FAERS reports before start: 85309 (lowers risk) · Drug's FDA history
Drug's FAERS reports in the prior 12 months: 21642 (lowers risk) · Drug's FDA history
Maximum age: 80 (lowers risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Number of arms: 1 (raises 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: 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: not given (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 80 (typical: 71)
Sex: male (typical: 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: 0 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 8 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 85309 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 21642 (typical: 412.5)
Drug's FAERS reports marked serious: 80.4% (typical: 85.6%)
Drug's FAERS reports with a death: 17.6% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: cyclophosphamide, cyclophosphamide doxorubicin vincristine, cytarabine methotrexate, doxorubicin, methotrexate, prednisolone, 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

Rituximab Plus CHOP With Sargramostim in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma NCT00599170 · started 2008 · scored riskier than 99% 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
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
Study of RTXM83 Plus CHOP Chemotherapy Versus a Rituximab Plus CHOP Therapy in Patients With Non Hodgkin's Lymphoma NCT02268045 · started 2013 · scored riskier than 35% of active trials completed
Feasibility Study Of Adding Bortezomib to R-ICE Chemotherapy To Treat Relapsed/ Refractory Diffuse Large B-Cell Lymphoma NCT01226849 · started 2010 · scored riskier than 40% 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.