A Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Participants With CD30-Positive Cutaneous T-Cell Lymphoma (ALCANZA Study)

NCT01578499 on ClinicalTrials.gov Phase 3 Millennium Pharmaceuticals, Inc. (industry) Started 2012-06-11 Completed

Riskier than 24% of active trials

Model scores of the 29,894 trials active now.

Model score 12% 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 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 2018-07-06, after 2012-06-11 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 2018-07-06. 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: 15.2% (raises risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 3 (lowers risk) · Design
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: celllymphomatherapychemotherapypatient
Phrases that lowered it: participantsparticipantmaleimmunoglobulinopen label
Drug's FAERS reports marked serious: 60.9% (lowers risk) · Drug's FDA history
Has a data monitoring committee: Yes (raises risk) · Design
Disease area, cancer: Yes (raises risk) · Disease area
Drug's FAERS reports with a death: 9.6% (lowers risk) · Drug's FDA history
Design: parallel (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Sponsor type: industry (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 22 (lowers risk) · Sponsor's track record
Drug's FAERS reports in the prior 12 months: 14292 (lowers risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
Collaborators: 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: 3 (typical: 2)
Number of arms: 2
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 1 (typical: 0)
Keywords listed: 2 (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: 33 (typical: 32)
Sponsor's past termination rate: 15.2% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 22 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 3 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 72548 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 14292 (typical: 412.5)
Drug's FAERS reports marked serious: 60.9% (typical: 85.6%)
Drug's FAERS reports with a death: 9.6% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, immunology, hematology
Drugs matched to FDA substances: bexarotene, brentuximab vedotin, methotrexate

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

Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides With Variable CD30 Expression Level NCT01396070 · started 2011 · scored riskier than 97% of active trials completed
Study on the Role of Brentuximab Vedotin as Single Agent in the Treatment of Relapsed/Refractory CD30+ PTCL Patients NCT02497131 · started 2015 · scored riskier than 69% of active trials completed
A Phase II Study of Single Agent Brentuximab Vedotin in Relapsed/Refractory CD30 Low (<10%) Mature T Cell Lymphoma (TCL) NCT02588651 · started 2016 · scored riskier than 98% of active trials completed
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
Brentuximab Vedotin in Chinese Participants With Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL) NCT02939014 · started 2016 · scored riskier than 37% 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.