Treatment With Combination Chemotherapy for Relapsed or Refractory Acute Lymphoblastic Leukemia

NCT03515200 on ClinicalTrials.gov Phase 1 St. Jude Children's Research Hospital (academic or other) Started 2018-04-20 Terminated

Riskier than 52% of active trials

Model scores of the 29,894 trials active now.

Model score 17% for any early termination, 8% 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 in 2015 or later: the model never saw it during training.

How it ended

Terminated on 2020-07-29, after 2018-04-20 start.

Reason given by the sponsor: “other”

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 2020-07-29. 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: leukemiaacutechemotherapycellspatients must
Phrases that lowered it: participantparticipantsmalefemalefunction
Sponsor's past termination rate: 15.4% (raises risk) · Sponsor's track record
Phase: 1 (lowers risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Disease area, cancer: Yes (raises risk) · Disease area
Design: single group (raises risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Drug's FAERS reports before start: 548624 (lowers risk) · Drug's FDA history
Drug's FAERS reports with a death: 13.8% (lowers risk) · Drug's FDA history
Drug's FAERS reports marked serious: 74.3% (lowers risk) · Drug's FDA history
Has a data monitoring committee: No (lowers risk) · Design
Minimum age: not given (lowers risk) · Who can join
Drug's FAERS reports in the prior 12 months: 112700 (lowers risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 16 (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Collaborators: 1 (raises risk) · Design
Sponsor's past trials: 117 (lowers risk) · Sponsor's track record
Responsible party: sponsor (lowers 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: 1 (typical: 2)
Number of arms: 1 (typical: 2)
Allocation: not applicable (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: 0 (typical: 1)

Who can join

Minimum age: not given (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: 117 (typical: 32)
Sponsor's past termination rate: 15.4% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 16 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 10 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 548624 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 112700 (typical: 412.5)
Drug's FAERS reports marked serious: 74.3% (typical: 85.6%)
Drug's FAERS reports with a death: 13.8% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, immunology, hematology
Drugs matched to FDA substances: bortezomib, cytarabine, dasatinib, dexamethasone, dobesilate, doxorubicin, hydrocortisone, 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

Palbociclib in Combo w/Chemotherapy in Peds Relapsed/Refractory Acute Lymphoblastic Leukemia NCT04996160 · started 2021 · scored riskier than 62% of active trials completed
Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL) NCT03792256 · started 2019 · scored riskier than 44% of active trials completed
Bortezomib and Vorinostat in Younger Patients With Refractory or Relapsed MLL Rearranged Hematologic Malignancies NCT02419755 · started 2015 · scored riskier than 98% of active trials terminated
Everolimus in Combination With Nelarabine, Cyclophosphamide and Etoposide in Lymphoblastic Leukemia/Lymphoma NCT03328104 · started 2018 · scored riskier than 65% of active trials completed
Safety Study of CPX-351 in Children With Relapsed Leukemia or Lymphoma NCT01943682 · started 2013 · scored riskier than 97% 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.