A Study to Evaluate the Safety and Efficacy of JCAR017 in Pediatric Subjects With Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL)
Model scores of the 29,894 trials active now.
Model score 30% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 29% of the time (655 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2024-01-26, after 2018-10-17 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 2024-01-26. 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: subject hasleukemiasubject ischemotherapytherapy
Phrases that lowered it: evaluate theto evaluateinvestigatorlymphomamg -
Sponsor's past termination rate: 16.5% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 1/2 (raises risk) · Design
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Design: single group (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 37 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 25.0% (raises risk) · Drug's FDA history
-
Keywords listed: 18 (raises risk) · Design
-
Drug's FAERS reports in the prior 12 months: 20377 (lowers risk) · Drug's FDA history
-
Drug's FAERS reports before start: 97313 (lowers risk) · Drug's FDA history
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
-
Drug's FAERS reports marked serious: 94.2% (raises risk) · Drug's FDA history
-
Sponsor's past trials: 170 (lowers risk) · Sponsor's track record
-
Number of arms: 1 (raises risk) · Design
-
Collaborators: 0 (raises risk) · Design
-
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
- 1/2 (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
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 18 (typical: 1)
Who can join
- Minimum age
- not given (typical: 18)
- Maximum age
- 25 (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
- 170 (typical: 32)
- Sponsor's past termination rate
- 16.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 37 (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
- 97313 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 20377 (typical: 412.5)
- Drug's FAERS reports marked serious
- 94.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 25.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, immunology, hematology
- Drugs matched to FDA substances
- cyclophosphamide, fludarabine
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
- A Study of CC-97540, CD19-targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma NCT04231747 · started 2020 · scored riskier than 84% of active trials completed
- Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia NCT02303821 · started 2015 · scored riskier than 68% of active trials completed
- Anti-CD19 White Blood Cells for Children and Young Adults With B Cell Leukemia or Lymphoma NCT01593696 · started 2012 · scored riskier than 73% of active trials completed
- Phase 3 Trial of Blinatumomab vs Standard Chemotherapy in Pediatric Subjects With HIgh-Risk (HR) First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) NCT02393859 · started 2015 · scored riskier than 60% of active trials completed
- CD22-CAR T Cells in Children and Young Adults With B Cell Malignancies NCT04088864 · started 2020 · scored riskier than 94% 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.