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

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: January 31, 2018

Interventions

  • 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).

Arms, Groups and Cohorts

  • Group 1 Sequential strategy
    • Patients for whom anti-PD-1 therapy was stopped with the introduction of a new treatment line (19 patients, 63%).
  • Group 2 Concomitant strategy
    • Patients for whom a combination of CT with anti-PD-1 therapy was initiated (11 patients, 37 %).

Clinical Trial Outcome Measures

Primary Measures

  • Overall response rate after re-exposure to chemotherapy
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Hospices Civils de Lyon
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hervé GHESQUIERES, MD, Principal Investigator, Hospices Civils de Lyon

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