An observational study in Hodgkin Lymphoma, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-10.
Sponsored by Hospices Civils de Lyon · Observational
Anti-PD-1 therapy provides high response rates in Hodgkin lymphoma (HL) patients who have relapsed or are refractory (R/R) to autologous stem cell transplantation (ASCT) and brentuximab vedotin (BV), but median progression free survival (PFS) is only one year. The efficacy of treatment following anti-PD-1 is not well known.
In this context, the optimal treatment for patients who failed after anti-PD-1 therapy is an issue. To better assess their outcome, the investigators retrospectively analyzed the characteristics and outcome of patients from 14 LYSA (The Lymphoma Study Association) centers who lost response to anti-PD-1 therapy and received additional CT.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 30 is below the median of 136 across 625 observational studies indexed under Lymphoma.
Browse Lymphoma studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The initial diagnosis of classical HL was established from biopsies in accordance with the 2008 World Health Organization classification14. We retrospectively analyzed 30 R/R classical HL patients from 14 LYSA centers who received anti-PD-1 therapy as part of a clinical trial (n=4), from an off-label program authorization for temporary use (ATU) from the French medical drug agency (Agence Nationale de Sécurité du Médicament, ANSM) (n=22), from the Belgian national system for the reimbursement of health care (Institut National d'Assurance Maladie Invalidité, INAMI) (n=4).
Exclusion Criteria:
Patients for whom anti-PD-1 therapy was stopped with the introduction of a new treatment line (19 patients, 63%).
Biological: Evaluate the improvement in response from the end of anti-PD-1 monotherapy
Patients for whom a combination of CT with anti-PD-1 therapy was initiated (11 patients, 37 %).
Biological: Evaluate the improvement in response from the end of anti-PD-1 monotherapy
Evaluate the improvement in response from the end of anti-PD-1 monotherapy to the first evaluation after introduction of CT alone (Group 1) or combined with anti-PD-1 (Group 2).
Overall response rate after re-exposure to chemotherapy
Patient evaluation was timed by treating physicians according to the policy of each center, and all patients were evaluated after a median of 10 weeks (min 7 weeks, max 12 weeks) with PET/CT using Lugano criteria
Time frame: 10 weeks
Best response obtained (Group 1)
the best response obtained with CT after anti-PD-1
Time frame: 10 weeks
Best response obtained (Group 2)
the best response obtained with CT after the combination anti-PD-1 and CT
Time frame: 10 weeks
The toxicities experienced during CT or anti-PD-1 plus CT combination
The toxicities were graded retrospectively according to the National Cancer Institute Common Toxicity Criteria for AEs (version 4.0).
Time frame: 10 weeks
Outcomes including PFS
PFS was defined as the time from first relapse, or progression, to the next event (defined as either second relapse/progression, change of therapy, or death from any cause)
Time frame: up to 12 months
Outcomes including overall survival (OS).
OS was defined as the time from first relapse, or progression, to death from any cause.
Time frame: up to 24 months
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospices Civils de Lyon