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NCT Number: NCT03664323

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 10, 2018
Registry last updated
Sep 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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