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

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ClinicalTrials.gov Identifier: NCT03664323
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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
Hodgkin Lymphoma Biological: Evaluate the improvement in response from the end of anti-PD-1 monotherapy

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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 : January 31, 2018
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : June 30, 2018

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Group/Cohort 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).




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Best response obtained (Group 1) [ Time Frame: 10 weeks ]
    the best response obtained with CT after anti-PD-1

  2. Best response obtained (Group 2) [ Time Frame: 10 weeks ]
    the best response obtained with CT after the combination anti-PD-1 and CT

  3. 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).

  4. 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)

  5. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664323


Locations
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France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Hervé GHESQUIERES, MD Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03664323     History of Changes
Other Study ID Numbers: Anti-PD-1 Hodgkin
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
Immunotherapy
chemotherapy
anti-PD1
re-sensibilization

Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases