Phase II Study of Dose-Adjusted EPOCH-Rituximab in Adults With Untreated Burkitt Lymphoma and c-MYC+ Diffuse Large B-Cell Lymphoma

NCT01092182 on ClinicalTrials.gov Phase 2 National Cancer Institute (NCI) (government) Started 2010-03-25 Completed

Riskier than 81% of active trials

Model scores of the 29,894 trials active now.

Model score 22% for any early termination, 13% 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 (376 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 2023-02-16, after 2010-03-25 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 2023-02-16. 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: patients mustchemotherapylymphomapatienttreating
Phrases that lowered it: participantshivnervoussubjectleukemia
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 2 (raises risk) · Design
Sponsor's past trials: 364 (lowers risk) · Sponsor's track record
Sponsor's past termination rate: 7.1% (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 215 (lowers risk) · Sponsor's track record
Disease area, cancer: Yes (raises risk) · Disease area
Design: parallel (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Drug's FAERS reports with a death: 20.1% (lowers risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports before start: 69117 (lowers risk) · Drug's FDA history
Drug's FAERS reports in the prior 12 months: 16249 (lowers risk) · Drug's FDA history
Maximum age: not given (raises risk) · Who can join
Collaborators: 0 (raises risk) · Design
Sponsor type: government (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: 3 (typical: 2)
Allocation: non randomized (typical: randomized)
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: principal investigator (typical: sponsor)
Collaborators: 0
Keywords listed: 6 (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: government (typical: academic or other)
Sponsor's past trials: 364 (typical: 32)
Sponsor's past termination rate: 7.1% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 215 (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: 69117 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 16249 (typical: 412.5)
Drug's FAERS reports marked serious: 86.8% (typical: 85.6%)
Drug's FAERS reports with a death: 20.1% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, infectious disease, immunology, urogenital, hematology
Drugs matched to FDA substances: cyclophosphamide, doxorubicin, etoposide, 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

Phase II Trial of Alemtuzumab (Campath) and Dose-Adjusted EPOCH-Rituximab (DA-EPOCH-R) in Relapsed or Refractory Diffuse Large B-Cell and Hodgkin Lymphomas NCT01030900 · started 2009 · scored riskier than 83% of active trials completed
Dose Adjusted EPOCH Regimen in Combination With Ofatumumab or Rituximab in Treating Patients With Newly Diagnosed or Relapsed or Refractory Burkitt Lymphoma or Relapsed or Refractory Acute Lymphoblastic Leukemia NCT02199184 · started 2015 · scored riskier than 81% 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
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
ME-401 and R-CHOP in Newly Diagnosed Diffuse Large B-Cell Lymphoma NCT04517435 · started 2021 · scored riskier than 92% of active trials terminated

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.