Bendamustine and Rituximab in Combination With Copanlisib for the Treatment of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

NCT04155840 on ClinicalTrials.gov Phase 2 University of Washington (academic or other) Started 2020-01-31 Terminated

Riskier than 39% of active trials

Model scores of the 29,894 trials active now.

Model score 15% 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 26% of the time (3,728 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Terminated on 2021-03-16, after 2020-01-31 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 2021-03-16. 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: transplantheartcellsfailureprocedure
Phrases that lowered it: leukemialymphomaclllymphocytictopical
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 2 (raises risk) · Design
Disease area, cancer: Yes (raises risk) · Disease area
Trials the sponsor started in the prior 2 years: 131 (lowers risk) · Sponsor's track record
Has a data monitoring committee: Yes (raises risk) · Design
Drug's FAERS reports with a death: 17.9% (lowers risk) · Drug's FDA history
Sponsor's past trials: 517 (lowers risk) · Sponsor's track record
Minimum age: 65 (lowers risk) · Who can join
Design: single group (raises risk) · Design
Drug's FAERS reports before start: 99618 (lowers risk) · Drug's FDA history
Sponsor type: academic or other (raises risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports in the prior 12 months: 19624 (lowers risk) · Drug's FDA history
Collaborators: 1 (raises risk) · Design
Number of arms: 1 (raises risk) · Design
Drugs with FDA adverse-event history: 3 (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: 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: principal investigator (typical: sponsor)
Collaborators: 1 (typical: 0)
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 65 (typical: 18)
Maximum age: not given (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 517 (typical: 32)
Sponsor's past termination rate: 7.7% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 131 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 3 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 99618 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 19624 (typical: 412.5)
Drug's FAERS reports marked serious: 90.5% (typical: 85.6%)
Drug's FAERS reports with a death: 17.9% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, immunology, hematology
Drugs matched to FDA substances: bendamustine, copanlisib, rituximab, rituximab abbs

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

Copanlisib and Combination Chemotherapy for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma or Relapsed Grade 3b Follicular Lymphoma NCT04156828 · started 2020 · scored riskier than 26% of active trials terminated
Copanlisib in Combination With Rituximab and CHOP Chemotherapy in Patients With Previously Untreated DLBCL NCT04263584 · started 2020 · scored riskier than 83% of active trials completed
A Study of Copanlisib and Ibrutinib in Mantle Cell Lymphoma NCT03877055 · started 2019 · scored riskier than 71% of active trials completed
Dose De-escalation Study of the PI3k Alpha/Delta Inhibitor, Copanlisib Given in Combination With the Immunotherapeutic Agents, Nivolumab and Rituximab in Patients With Relapsed/Refractory Indolent Lymphoma NCT04431635 · started 2020 · scored riskier than 58% of active trials terminated
Copanlisib and Gemcitabine in Relapsed/Refractory PTCL NCT03052933 · started 2018 · scored riskier than 81% 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.