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A Phase I Study of 5-Azacytidine in Combination With Chemotherapy for Children With Relapsed or Refractory ALL or AML

NCT01861002 on ClinicalTrials.gov Phase 1 Therapeutic Advances in Childhood Leukemia Consortium (academic or other) Started 2013-05-22 Completed
Among the riskiest 1% of active trials
this trial: 38% 0% 36%

Model scores of the 29,894 trials active now.

Model score 38% for any early termination, 18% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 23% of the time (1,629 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 2014-07-28, after 2013-05-22 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

0% 14% 29% 43% 58% 0123456 yr completed 34% terminated 50%

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2014-07-28. 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

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 (typical: 2)
Number of arms
2
Allocation
non randomized (typical: randomized)
Design
single group (typical: parallel)
Primary purpose
treatment
Blinding
none
Has a data monitoring committee
Yes (typical: 56% yes)
Responsible party
sponsor
Collaborators
1 (typical: 0)
Keywords listed
13 (typical: 1)

Who can join

Minimum age
1 (typical: 18)
Maximum age
21 (typical: 71)
Sex
all
Accepts healthy volunteers
No (typical: 9% yes)

Sponsor's track record

Sponsor type
academic or other
Sponsor's past trials
6 (typical: 32)
Sponsor's past termination rate
83.3% (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
5 (typical: 1)
Drug has FAERS history
Yes (typical: 64% yes)
Drug's FAERS reports before start
107875 (typical: 2148)
Drug's FAERS reports in the prior 12 months
20967 (typical: 412.5)
Drug's FAERS reports marked serious
66.9% (typical: 85.6%)
Drug's FAERS reports with a death
14.4% (typical: 15.9%)

Disease area and drugs

Disease areas
cancer, immunology, hematology
Drugs matched to FDA substances
azacitidine, cytarabine, cytosine, fludarabine, 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

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.