Phase II Trial of LMB-2, Fludarabine and Cyclophosphamide for Adult T-Cell Leukemia
Model scores of the 29,894 trials active now.
Model score 23% for any early termination, 17% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 30% of the time (96 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 2021-05-05, after 2008-10-31 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
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2021-05-05. 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: equalgreater thancellpatientsiv
Phrases that lowered it: immunogenicitypharmacokineticsadultthe effecteffect of -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 5.1% (lowers risk) · Sponsor's track record
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Phase: 1/2 (raises risk) · Design
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Maximum age: 100 (lowers risk) · Who can join
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Drug's FAERS reports with a death: 27.7% (raises risk) · Drug's FDA history
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Design: single group (raises risk) · Design
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Sponsor's past trials: 257 (lowers risk) · Sponsor's track record
-
Has a data monitoring committee: No (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 94.9% (raises risk) · Drug's FDA history
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Number of arms: 1 (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 242 (lowers risk) · Sponsor's track record
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Drug's FAERS reports before start: 10849 (raises risk) · Drug's FDA history
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
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 8 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 100 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- government (typical: academic or other)
- Sponsor's past trials
- 257 (typical: 32)
- Sponsor's past termination rate
- 5.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 242 (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
- 10849 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3160 (typical: 412.5)
- Drug's FAERS reports marked serious
- 94.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 27.7% (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
- Subcutaneous Recombinant Human IL-15 (s.c. rhIL-15) and Alemtuzumab for People With Refractory or Relapsed Chronic and Acute Adult T-cell Leukemia (ATL) NCT02689453 · started 2017 · scored riskier than 97% of active trials completed
- A Phase II Study Of Imtox-25 In Adults With Refractory/Relapsed Cd25 Positive Adult T Cell Leukemia/Lymphoma NCT01378871 · started 2010 · scored riskier than 97% of active trials terminated
- Phase III B in Acute Lymphoblastic Leukemia NCT03123939 · started 2017 · scored riskier than 96% of active trials completed
- Chemotherapy, Total-Body Irradiation, Donor Natural Killer Cell Infusion, Aldesleukin, and UCB Transplant in Treating Patients With Relapsed or Refractory AML NCT00871689 · started 2009 · scored riskier than 96% of active trials terminated
- CART-38 in Adult AML and MM Patients NCT05442580 · started 2023 · scored riskier than 66% of active trials terminated
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.