The Ruxolitinib Versus Best Available Therapy Trial in Patients With High Risk ET in Second Line

NCT02962388 on ClinicalTrials.gov Phase 2/3 French Innovative Leukemia Organisation (academic or other) Started 2017-01-03 Terminated

Riskier than 74% of active trials

Model scores of the 29,894 trials active now.

Model score 21% for any early termination, 11% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 13% of the time (1,012 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Terminated on 2021-06-28, after 2017-01-03 start.

Reason given by the sponsor: “enrollment”

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 2021-06-28. 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: or equalcellpatientsconcurrenttherapy
Phrases that lowered it: doseevaluate thebleedingto evaluatestudy to
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 10% (raises risk) · Sponsor's track record
Drug's FAERS reports marked serious: 60.5% (lowers risk) · Drug's FDA history
Design: parallel (raises risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Minimum age: 18 (raises risk) · Who can join
Phase: 2/3 (raises risk) · Design
Drug's FAERS reports with a death: 19.4% (lowers risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
Maximum age: 74 (lowers risk) · Who can join
Collaborators: 1 (raises risk) · Design
Number of arms: 2 (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: 2/3 (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: 74 (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 20 (typical: 32)
Sponsor's past termination rate: 10% (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: 2 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 13618 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 5529 (typical: 412.5)
Drug's FAERS reports marked serious: 60.5% (typical: 85.6%)
Drug's FAERS reports with a death: 19.4% (typical: 15.9%)

Disease area and drugs

Disease areas: hematology
Drugs matched to FDA substances: anagrelide, ruxolitinib

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

Efficacy and Safety of Ruxolitinib in the Treatment of Anemic Myelofibrosis Patients. NCT02966353 · started 2017 · scored riskier than 79% of active trials completed
A Study to Evaluate the Relative Bioavailability of Ruxolitinib Extended Release (XR) Tablets Compared With Ruxolitinib Immediate Release (IR) Tablets Administered Orally in Healthy Participants. NCT06310304 · started 2024 · scored riskier than 2% of active trials completed
An Efficacy and Safety Study of Fedratinib Compared to Best Available Therapy in Subjects With DIPSS-intermediate or High-risk Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib NCT03952039 · started 2019 · scored riskier than 62% of active trials completed
Jaktinib for the Treatment of Ruxolitinib Intolerance of Myelofibrosis NCT04217993 · started 2020 · scored riskier than 52% of active trials completed
A Study to Evaluate the Bioequivalence of Ruxolitinib Extended Release (XR) Tablets With Ruxolitinib Immediate Release (IR) Tablets Administered Orally in Healthy Participants NCT06555081 · started 2024 · scored riskier than 2% 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.