Chemotherapy Based on Positron Emission Tomography Scan in Treating Patients With Stage I or Stage II Hodgkin Lymphoma

NCT01132807 on ClinicalTrials.gov Phase 2 Alliance for Clinical Trials in Oncology (academic or other) Started 2010-05-31 Completed

Riskier than 36% of active trials

Model scores of the 29,894 trials active now.

Model score 14% for any early termination, 6% 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 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 2018-01-31, after 2010-05-31 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 2018-01-31. 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: stageconcurrentdisease characteristicscellspatients must
Phrases that lowered it: lymphomaaccordinghivtrialadult
Sponsor's past termination rate: 3.4% (lowers risk) · Sponsor's track record
Phase: 2 (raises risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past trials: 175 (lowers risk) · Sponsor's track record
Disease area, cancer: Yes (raises risk) · Disease area
Trials the sponsor started in the prior 2 years: 38 (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 19.5% (lowers risk) · Drug's FDA history
Design: single group (raises risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Drug's FAERS reports in the prior 12 months: 13238 (lowers risk) · Drug's FDA history
Number of arms: 1 (raises risk) · Design
Primary purpose: treatment (raises risk) · Design
Maximum age: 60 (lowers risk) · Who can join
Drug's FAERS reports before start: 61975 (lowers risk) · Drug's FDA history
Has a data monitoring committee: No (lowers risk) · Design
Collaborators: 1 (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: 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: sponsor
Collaborators: 1 (typical: 0)
Keywords listed: 2 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 60 (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 175 (typical: 32)
Sponsor's past termination rate: 3.4% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 38 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 9 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 61975 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 13238 (typical: 412.5)
Drug's FAERS reports marked serious: 85.4% (typical: 85.6%)
Drug's FAERS reports with a death: 19.5% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, immunology, hematology
Drugs matched to FDA substances: bleomycin, cyclophosphamide, dacarbazine, doxorubicin, etoposide, prednisone, procarbazine, radiation therapy

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

Chemotherapy Based on PET Scan in Treating Patients With Stage I or Stage II Hodgkin Lymphoma NCT01390584 · started 2013 · scored riskier than 75% of active trials terminated
Fludeoxyglucose F 18-PET/CT Imaging in Assessing Response to Chemotherapy in Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Hodgkin Lymphoma NCT00678327 · started 2008 · scored riskier than 83% of active trials completed
S0816 Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma NCT00822120 · started 2009 · scored riskier than 75% of active trials completed
Response-Based Therapy Assessed By PET Scan in Treating Patients With Bulky Stage I and Stage II Classical Hodgkin Lymphoma NCT01118026 · started 2010 · scored riskier than 81% of active trials completed
Gemcitabine and Bendamustine in Patients With Relapsed or Refractory Hodgkin's Lymphoma NCT01535924 · started 2012 · scored riskier than 64% 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.