TCR Alpha Beta T-cell and CD19 B-cell Depleted Peripheral Blood Stem Cell Transplantation Using the CliniMACS System for Patients With Non-Malignant Hematologic Disorders From Matched or Mismatched, Related or Unrelated Donors
Model scores of the 29,894 trials active now.
Model score 17% 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 16% of the time (1,198 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2020-11-13, after 2018-07-23 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 2020-11-13. 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
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: anemiasyndromesubjectdiseasemri
Phrases that lowered it: participantpatientsblooddonationhealthy -
Accepts healthy volunteers: No (raises risk) · Who can join
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Trials the sponsor started in the prior 2 years: 124 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: not given (lowers risk) · Design
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Sponsor's past termination rate: 5.1% (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 33.9% (raises risk) · Drug's FDA history
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Sponsor's past trials: 492 (lowers risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Drug's FAERS reports marked serious: 97.1% (raises risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Minimum age: 1 (lowers risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports before start: 30883 (raises risk) · Drug's FDA history
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Responsible party: sponsor (lowers risk) · Design
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Collaborators: 0 (raises risk) · Design
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Maximum age: 69 (lowers risk) · Who can join
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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
- Number of arms
- 2
- Allocation
- non randomized (typical: randomized)
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 8 (typical: 1)
Who can join
- Minimum age
- 1 (typical: 18)
- Maximum age
- 69 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 492 (typical: 32)
- Sponsor's past termination rate
- 5.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 124 (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
- 30883 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 5409 (typical: 412.5)
- Drug's FAERS reports marked serious
- 97.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 33.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- clofarabine, fludarabine, melphalan, rabbit, thiotepa
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
- Hematopoietic Stem Cell Transplant for Sickle Cell Disease NCT02065596 · started 2015 · scored riskier than 98% of active trials completed
- Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts in Preventing GVHD in Children NCT01858740 · started 2014 · scored riskier than 77% of active trials completed
- Stem Cell Transplant Using Peripheral and Cord Blood Stem Cells to Treat Severe Aplastic Anemia and Myelodysplastic Syndrome NCT00604201 · started 2008 · scored riskier than 58% of active trials completed
- A Research Study of Bone Marrow Transplantation From Unrelated or Partially Matched Related Donors NCT01349101 · started 2011 · scored riskier than 98% of active trials completed
- CD34 Selected Allogeneic HCT w/ Myeloablative Conditioning Plus CD8+ Memory TCell Infusion in MDS, AL and CML NCT04151706 · started 2020 · scored riskier than 67% 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.