Anti-PD-1 and Chemotherapy for R/R Hodgkin Lymphoma

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT03664323

Collaborator

(none)

Enrollment

Location

4.9

Actual Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hodgkin Lymphoma	Biological: Evaluate the improvement in response from the end of anti-PD-1 monotherapy

Study Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Efficacy of Chemotherapy or Chemo-anti-PD-1 Combination After Failed Anti-PD-1 Therapy for Relapsed and Refractory Hodgkin Lymphoma: a Series From Lysa Centers.

Actual Study Start Date :

Jan 31, 2018

Actual Primary Completion Date :

Jan 31, 2018

Actual Study Completion Date :

Jun 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Group 1 Sequential strategy 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 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).
Group 2 Concomitant strategy 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).

Arm

Intervention/Treatment

Group 1 Sequential strategy

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

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).

Group 2 Concomitant strategy

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).

Outcome Measures

Primary Outcome Measures

Overall response rate after re-exposure to chemotherapy [10 weeks]
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

Secondary Outcome Measures

Best response obtained (Group 1) [10 weeks]
the best response obtained with CT after anti-PD-1
Best response obtained (Group 2) [10 weeks]
the best response obtained with CT after the combination anti-PD-1 and CT
The toxicities experienced during CT or anti-PD-1 plus CT combination [10 weeks]
The toxicities were graded retrospectively according to the National Cancer Institute Common Toxicity Criteria for AEs (version 4.0).
Outcomes including PFS [up to 12 months]
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)
Outcomes including overall survival (OS). [up to 24 months]
OS was defined as the time from first relapse, or progression, to death from any cause.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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.