Phase l/II Study of Ruxolitinib for Acute Leukemia

NCT01251965 on ClinicalTrials.gov Phase 1/2 M.D. Anderson Cancer Center (academic or other) Started 2010-12-31 Terminated

Riskier than 91% of active trials

Model scores of the 29,894 trials active now.

Model score 26% 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 26% of the time (851 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

Terminated on 2012-07-31, after 2010-12-31 start.

Reason given by the sponsor: “other”

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 2012-07-31. 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

Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: equal tocellrelapsedrefractorygrade
Phrases that lowered it: femalesparticipatingaminotransferasesafety offemale
Sponsor's past termination rate: 28.8% (raises risk) · Sponsor's track record
Phase: 1/2 (raises risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Disease area, cancer: Yes (raises risk) · Disease area
Sponsor type: academic or other (raises risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 156 (lowers risk) · Sponsor's track record
Design: single group (raises risk) · Design
Sponsor's past trials: 271 (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
Maximum age: not given (raises risk) · Who can join
Has a data monitoring committee: No (lowers risk) · Design
Collaborators: 1 (raises risk) · Design
Number of arms: 3 (lowers risk) · Design
Responsible party: sponsor (lowers risk) · Design
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
Minimum age: 14 (raises risk) · Who can join

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: 1/2 (typical: 2)
Number of arms: 3 (typical: 2)
Allocation: non randomized (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: 1 (typical: 0)
Keywords listed: 9 (typical: 1)

Who can join

Minimum age: 14 (typical: 18)
Maximum age: not given (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 271 (typical: 32)
Sponsor's past termination rate: 28.8% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 156 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 0 (typical: 1)
Drug has FAERS history: No (typical: 64% yes)
Drug's FAERS reports before start: 0 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 0 (typical: 412.5)
Drug's FAERS reports marked serious: no FAERS history (typical: 85.6%)
Drug's FAERS reports with a death: no FAERS history (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, immunology, hematology
Drugs matched to FDA substances: 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

Testing the Effect of Taking Ruxolitinib and CPX-351 in Combination for the Treatment of Advanced Phase Myeloproliferative Neoplasms NCT03878199 · started 2019 · scored riskier than 83% of active trials terminated
Ruxolitinib Phosphate in Treating Patients With Chronic Neutrophilic Leukemia or Atypical Chronic Myeloid Leukemia NCT02092324 · started 2014 · scored riskier than 98% of active trials completed
A Sequential Two-Stage Dose Escalation Study to Evaluate the Safety and Efficacy of Ruxolitinib NCT01776723 · started 2013 · scored riskier than 97% of active trials completed
Ruxolitinib Phosphate in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma NCT03041636 · started 2017 · scored riskier than 87% of active trials completed
INCB018424 in Patients With Advanced Hematologic Malignancies NCT00674479 · started 2008 · scored riskier than 99% 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.