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

NCT03664323 | Completed

• 1 other identifier: Anti-PD-1 Hodgkin
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hodgkin Lymphoma

Keywords

Immunotherapy; chemotherapy; anti-PD1; re-sensibilization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Best response obtained (Group 1)

  10 weeks

• Best response obtained (Group 2)

  10 weeks

• The toxicities experienced during CT or anti-PD-1 plus CT combination

  10 weeks

• Outcomes including PFS

  up to 12 months

• Outcomes including overall survival (OS).

  up to 24 months

Study Arms (2)

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

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

Interventions

Evaluate the improvement in response from the end of anti-PD-1 monotherapy BIOLOGICAL

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 1 Sequential strategy; Group 2 Concomitant strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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,
• 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.

You may not qualify if:

• \- radiotherapy in the treatment after anti-PD1

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Location

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Hervé GHESQUIERES, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: September 10, 2018
• Study Start: January 31, 2018
• Primary Completion: January 31, 2018
• Study Completion: June 30, 2018
• Last Updated: September 10, 2018

Record last verified: 2018-09

Locations

FR (1)