NCT04621604

Brief Summary

Anti-PD-1antibodies (iPD-1) are indicated as monotherapy in the treatment of adult patients with classical LH. The recommended dosage in LH is based on solid tumour experience and no dose-concentration-effect studies have been conducted. According to the literature, therapeutic efficacy appears to be highly variable, and could be related to differences in treatment exposure. Since Total metabolic tumor volume (TMTV) is a prognostic factor in LH and the clearance of iPD-1, and thus exposure to iPD-1, is related to clinical efficacy, we hypothesize that TMTV influences the exposure to iPD-1 and thus its therapeutic efficacy. The aim of this study is to evaluate the relationship between TMTV and anti-PD-1 exposure in refractory or relapsed LH.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 9, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

April 12, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2023

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

1.7 years

First QC Date

November 4, 2020

Last Update Submit

October 27, 2023

Conditions

Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Pearson's correlation between the initial Tumour Metabolic Total Volume and the area under the curve of iPD-1 .

    linear relationship, using Pearson's correlation, between the initial Tumour Metabolic Total Volume and the area under the curve (AUC) of iPD-1 during the first treatment.

    1 month

Secondary Outcomes (8)

  • Correlation between treatment exposure and initial TMTV for each cycle

    3 months

  • Correlation between treatment exposure and TMTV at 3 months for each cycle

    3 months

  • Correlation between treatment exposure and response to treatment at 3 months

    3 months

  • Correlation between treatment exposure and cell free DNA at 3 months

    3 months

  • Correlation between treatment exposure and PD-1 after 3 months

    3 months

  • +3 more secondary outcomes

Study Arms (1)

Patients

EXPERIMENTAL
Other: blood samples

Interventions

blood samplesOTHER

Extra blood samples will be collected during chemotherapy administration to analyze pharmacokinetics of the iPD1

Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient at least 18 years of age
  • Patient for whom anti-PD-1 antibody therapy (nivolumab or pembrolizumab) is given as monotherapy for relapsed or refractory classical Hodgkin's lymphoma within the scope of the WMA.
  • Patient for whom a PET-CT for the evaluation of TMTV is available within 30 days prior to the first treatment without intercurrent antitumour therapy between the last PET-CT and the start of anti-PD1 treatment.
  • For women of childbearing age, use of effective contraception
  • Patient with free, informed and written consent
  • Patient affiliated to a social security scheme

You may not qualify if:

  • Persons of full age subject to legal protection (judicial protection, guardianship, trusteeship), persons deprived of their liberty, pregnant or breastfeeding women, persons unable to give consent
  • Patient with a contraindication to NIV or PEM treatment
  • Patient previously treated with anti-PD1 regardless of indication
  • Patient treated with anti-PD1 in combination with other anti-tumour treatment
  • Patient participating in another interventional clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

CHU Angers

Angers, France

Location

CHU Dijon

Dijon, France

Location

CHU Nantes

Nantes, France

Location

CH Orléans

Orléans, France

Location

CHU Poitiers

Poitiers, France

Location

CHU Rennes

Rennes, France

Location

CHU Tours

Tours, France

Location

CHBA Vannes

Vannes, France

Location

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Roch Houot, Pr

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2020

First Posted

November 9, 2020

Study Start

April 12, 2021

Primary Completion

January 10, 2023

Study Completion

October 20, 2023

Last Updated

October 31, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(8)