A Safety, Tolerability and Preliminary Efficacy Study of CC-90011 in Combination With Venetoclax and Azacitidine in R/R Acute Myeloid Leukemia and Treatment-naïve Participants Not Eligible for Intensive Therapy
Model scores of the 29,894 trials active now.
Model score 17% for any early termination, 2% 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 (1,938 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2022-03-09, after 2021-10-14 start.
Reason given by the sponsor: “business”
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 2022-03-09. 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: chemotherapyleukemiaamltransplanttherapy
Phrases that lowered it: participantparticipantsvaccineopen label19 -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 1 (lowers risk) · Design
-
Sponsor's past termination rate: 14.0% (raises risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 36.6% (raises risk) · Drug's FDA history
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 43 (lowers risk) · Sponsor's track record
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Sponsor's past trials: 229 (lowers risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 95.1% (raises risk) · Drug's FDA history
-
Number of arms: 3 (lowers risk) · Design
-
Maximum age: not given (raises risk) · Who can join
-
Responsible party: sponsor (lowers risk) · Design
-
Has a data monitoring committee: No (lowers risk) · Design
-
Drugs with FDA adverse-event history: 4 (lowers risk) · Drug's FDA history
-
Drug's FAERS reports in the prior 12 months: 8385 (lowers 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 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- sequential (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (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
- 229 (typical: 32)
- Sponsor's past termination rate
- 14.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 43 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 4 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 38657 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 8385 (typical: 412.5)
- Drug's FAERS reports marked serious
- 95.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 36.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, hematology
- Drugs matched to FDA substances
- azacitidine, cc90011, pulrodemstat besilate, venetoclax
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 Safety and Efficacy Study of CC-90009 Combinations in Subjects With Acute Myeloid Leukemia NCT04336982 · started 2020 · scored riskier than 65% of active trials terminated
- A Study of Venetoclax in Combination With Low Dose Cytarabine Versus Low Dose Cytarabine Alone in Treatment Naive Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy NCT03069352 · started 2017 · scored riskier than 76% of active trials completed
- Magrolimab, Azacitidine, and Venetoclax for the Treatment of Acute Myeloid Leukemia NCT04435691 · started 2020 · scored riskier than 88% of active trials terminated
- A Study Evaluating Venetoclax in Combination With Low-Dose Cytarabine in Treatment-Naïve Participants With Acute Myelogenous Leukemia NCT02287233 · started 2014 · scored riskier than 93% of active trials completed
- Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in Patients With Relapsed or Refractory CD33+ Acute Myeloid Leukemia:Big Ten Cancer Research Consortium BTCRC-AML17-113 NCT04070768 · started 2019 · scored riskier than 96% 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.