Evaluation of the Relationship Between Anti-PD-1 Exposure and Tumour VOLUME in Patients Treated for Classical HODgkin's Lymphoma.
NCT ID: NCT04621604
Last Updated: 2023-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
7 participants
INTERVENTIONAL
2021-04-12
2023-10-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase II Trial of Anti-PD-1 Antibody Treatment and Radiotherapy in Early-stage Favorable Classic Hodgkin Lymphoma
NCT06916416
Anti-PD-1 and Chemotherapy for R/R Hodgkin Lymphoma
NCT03664323
A Study of Two Associations of Rituximab and Chemotherapy, With a PET-driven Strategy, in Lymphoma
NCT00498043
Radiation Free Chemotherapy for Early Hodgkin Lymphoma
NCT04866654
A Study of AK129 With or Without AK117 in PD(L)1-refractory Classic Hodgkin Lymphoma
NCT06642792
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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. Highlighting such a relationship will make it possible to identify treatment algorithms according to the initial TMTV with a target plasma concentration defined according to the TMTV measurement. New therapeutic biomarkers would thus be highlighted.
This personalised medicine approach would make it possible to maximise the effect while reducing toxicity. This project is a first step in the implementation of a clinical study leading to recommendations for anti-PD-1 dose adaptation based on concentration and TMTV.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients
blood samples
Extra blood samples will be collected during chemotherapy administration to analyze pharmacokinetics of the iPD1
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
blood samples
Extra blood samples will be collected during chemotherapy administration to analyze pharmacokinetics of the iPD1
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rennes University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Roch Houot, Pr
Role: PRINCIPAL_INVESTIGATOR
Rennes University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Angers
Angers, , France
CHU Dijon
Dijon, , France
CHU Nantes
Nantes, , France
CH Orléans
Orléans, , France
CHU Poitiers
Poitiers, , France
CHU Rennes
Rennes, , France
CHU Tours
Tours, , France
CHBA Vannes
Vannes, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
35RC17_9804_REVOLUMHOD
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.