Hodgkin LymphomaREVOLUMHODNCT04621604
Evaluation of the Relationship Between Anti-PD-1 Exposure and Tumour VOLUME in Patients Treated for Classical HODgkin's Lymphoma.
A study testing blood samples in people with Hodgkin Lymphoma, run by Rennes University Hospital at 8 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin Lymphoma
- What is being tested?
- blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 8 sitesFrance
- Study dates
- 12 Apr 2021to 20 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CHU Angers
Angers
CHU Dijon
Dijon
CHU Nantes
Nantes
CH Orléans
Orléans
CHU Poitiers
Poitiers
CHU Rennes
Rennes
CHU Tours
Tours
CHBA Vannes
Vannes
About this study
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.
Read more
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.
Read the detailed description
Anti-PD-1antibodies (iPD-1), nivolumab (NIV) and pembrolizumab (PEM), act by blocking the interaction of the PD-1 receptor with its PDL1/PDL-2 ligands, which are overexpressed by tumour cells and their microenvironment, thus restoring an effective anti-tumour response. NIV and PEM are indicated as monotherapy in the treatment of adult patients with classical LH. They are administered as intravenous infusions on an outpatient basis. The recommended dosage for IVN or EMP 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. 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
- Hodgkin Lymphoma
- Being tested
- blood samples
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesOther
Extra blood samples will be collected during chemotherapy administration to analyze pharmacokinetics of the iPD1
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Not described Receives: Other: blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (8)
Correlation between treatment exposure and initial TMTV for each cycle
Degree of correlation between AUC, peak concentration (Cmax), residual concentration (Cmin) measured at each treatment cycle of the first 3 months, and initial TMTV (tumour Metabolic Total Volume)
Measured: 3 months
Correlation between treatment exposure and TMTV at 3 months for each cycle
Degree of correlation between AUC, peak concentration (Cmax), residual concentration (Cmin) measured at each treatment cycle of the first 3 months, and TMTV (tumour Metabolic Total Volume) at 3 months
Measured: 3 months
Correlation between treatment exposure and response to treatment at 3 months
Degree of correlation between AUC, peak concentration (Cmax), and residual concentration (Cmin) measured at each treatment cycle in the first 3 months, and response to treatment as assessed by PET/CT at 3 months
Measured: 3 months
Correlation between treatment exposure and cell free DNA at 3 months
Degree of correlation between AUC, peak concentration (Cmax), and residual concentration (Cmin) measured at each treatment cycle, and cfDNA quantification at 3 months.
Measured: 3 months
Correlation between treatment exposure and PD-1 after 3 months
Degree of correlation between AUC, peak concentration (Cmax), and residual concentration (Cmin) measured at each treatment cycle of the first 3 months, and the expression of membrane (in the tumour before treatment) and soluble PD-1, PDL-1, and PDL-2 (in plasma before treatment and during the first 3 months of treatment)
Measured: 3 months
Correlation between treatment exposure and tolerance after 3 months
Degree of correlation between anti-PD-1 AUC, Cmax or Cmin of anti-PD-1 at each treatment cycle in the first 3 months, and occurrence of immunological adverse events (irAE) within 3 months of starting treatment
Measured: 3 months
Correlation between treatment exposure and progression-free survival
Degree of correlation between anti-PD-1 AUC, Cmax or Cmin of anti-PD-1 at each treatment cycle in the first 3 months, and progression-free survival
Measured: 1 year
Correlation between treatment exposure and overall survival
Degree of correlation between anti-PD-1 AUC, Cmax or Cmin of anti-PD-1 at each treatment cycle in the first 3 months, and overall survival (OS).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start12 Apr 2021
- Primary completion10 Jan 2023
- Study completion20 Oct 2023
Why it stopped: lack of eligible patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roch Houot, Pr, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621604
- Sponsor's protocol ID
- 35RC17_9804_REVOLUMHOD
- Acronym
- REVOLUMHOD
- Status last verified
- Oct 2023
- First submitted
- 4 Nov 2020
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Anti-PD-1 Exposure and Tumour VOLUME in Patients Treated for Classical HODgkin's Lymphoma.
- ClinicalTrials.gov ID
- NCT04621604
- Acronym / sponsor ID
- REVOLUMHOD / 35RC17_9804_REVOLUMHOD
- Conditions
- Hodgkin Lymphoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of eligible patients
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Anti-PD-1antibodies (iPD-1), nivolumab (NIV) and pembrolizumab (PEM), act by blocking the interaction of the PD-1 receptor with its PDL1/PDL-2 ligands, which are overexpressed by tumour cells and their microenvironment, thus restoring an effective anti-tumour response. NIV and PEM are indicated as monotherapy in the treatment of adult patients with classical LH. They are administered as intravenous infusions on an outpatient basis. The recommended dosage for IVN or EMP 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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: blood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplesExtra blood samples will be collected during chemotherapy administration to analyze pharmacokinetics of the iPD1 | Other | Patients |
Primary outcome
Pearson's correlation between the initial Tumour Metabolic Total Volume and the area under the curve of iPD-1 .
Time frame: 1 month
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.
8 secondary outcomes
Correlation between treatment exposure and initial TMTV for each cycle
Time frame: 3 months
Correlation between treatment exposure and TMTV at 3 months for each cycle
Time frame: 3 months
Correlation between treatment exposure and response to treatment at 3 months
Time frame: 3 months
Correlation between treatment exposure and cell free DNA at 3 months
Time frame: 3 months
Correlation between treatment exposure and PD-1 after 3 months
Time frame: 3 months
Correlation between treatment exposure and tolerance after 3 months
Time frame: 3 months
Correlation between treatment exposure and progression-free survival
Time frame: 1 year
Correlation between treatment exposure and overall survival
Time frame: 1 year
Results and safety
The study was stopped early (reason given: lack of eligible patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Hodgkin Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roch Houot, Pr principal investigator
Rennes University Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood samples in people with Hodgkin Lymphoma, run by Rennes University Hospital at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of eligible patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pearson's correlation between the initial Tumour Metabolic Total Volume and the area under the curve of iPD-1 . (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.