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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03664323
Other study ID # Anti-PD-1 Hodgkin
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 31, 2018
Est. completion date June 30, 2018

Study information

Verified date September 2018
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 30, 2018
Est. primary completion date January 31, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Initial diagnosis of classical HL

- Optional histopathology confirmation of relapse/refractory HL, (2) age = 18 years

- Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 to 2

- Patients must be have received: at least 2 prior regimens and have received or be ineligible for autologous stem cell transplant and must have received prior BV, and at least 2 cycles of single agent anti-PD-1 as last treatment before entering the study,

- Patients must have inadequate response to anti-PD-1 monotherapy (progressive disease or partial response according to Lugano criteria) with at least one hypermetabolic lesion over the liver and mediastinum background at time of inclusion in the study

- Previous allogeneic stem cell transplant was allowed. Patients treated with radiotherapy alone after anti-PD1 or combined with anti-PD1 treatment were not included in the study.

Exclusion Criteria:

- radiotherapy in the treatment after anti-PD1

Study Design


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
France Centre Hospitalier Lyon Sud Pierre-Bénite

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 10 weeks
Secondary Best response obtained (Group 1) the best response obtained with CT after anti-PD-1 10 weeks
Secondary Best response obtained (Group 2) the best response obtained with CT after the combination anti-PD-1 and CT 10 weeks
Secondary 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). 10 weeks
Secondary 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) up to 12 months
Secondary Outcomes including overall survival (OS). OS was defined as the time from first relapse, or progression, to death from any cause. up to 24 months
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