Prognostic Significance of ctDNA in HL
ConditionPrognostic Cancer Model
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInterni hematologicka klinika FNKV
About this trial
Specific somatic mutations using ctDNA will be analyzed in predefined subgroups of cHL (e.g., age \<60 and ≥ 60 years, EBV). These mutations will be correlated with response to the treatment in the first line, in the relapse, during brentuximab vedotin and/or nivolumab treatment. Circulating tumor DNA will be correlated with the extent of tumor mass and chemo/radiotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients ≥ 18 years with newly histologically confirmed classical Hodgkin lymphoma (cHL) will be enrolled
signing the informed consent
Disqualifiers
Pacients without signing the informed consent
Trial population
Patients ≥ 18 years with new HL, all patients will undergo standard diagnostic procedures and will be divided based by stages and risk factors. Patients below 60 years will be divided into 3 treatment risk groups and treated according to the standard recommendations explained as well as elderly patients (see study groups). Younger relapsed patients will be treated with salvage platinum-based chemotherapy followed by high-dose chemotherapy and autologous stem cell transplantation (ASCT). Relapses after ASCT in younger patients or after at least two lines of chemotherapy in elderly patients will be treated with brentuximab vedotin (up to 16 cycles) or nivolumab until progression.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 6 trial groups6
Trial groupsSee each trial group below.
Group A: Standard first line treatment, stages I or II without risk factors
Group B: Patients < 60 years, stages I or II and 1 risk factor
Group C: Patients < 60 years, stages III or IV with MMT and/or EN disease
Group D: Elderly patients ≥ 60 years and 1 risk factor
Group E: Elderly patients ≥ 60 years, stages III or IV
Group F: Relapsed patients up to 65 years
Trial outcomes
Primary outcomes
1
Identification of tumor specific mutation profiles at dg. of HL based on ctDNA
Identification of tumor specific mutation profiles at diagnosis of classical Hodgkin: 1. age at diagnosis \< 60 years in comparison to patients with age at diagnosis 60 years and more 2. EBV negative versus EBV positive cases 3. correlation with the first line treatment outcome lymphoma based on ctDNA analysis with correlation to clinical and pathological characteristics
Time frame
4 years2
Quantitative analysis of ctDNA level during the first-line chemotherapy
Quantitative analysis of ctDNA level during the first-line chemotherapy: 1. analysis in relation to the type of chemotherapy: BEACOPP escalated vs ABVD 2. dynamics of ctDNA decline in correlation with treatment response
Time frame
4 years3
Identification of tumor specific mutation profiles at relapse of classical HL
Identification of tumor specific mutation profiles at relapse of classical Hodgkin lymphoma: 1. detection of newly developed mutations in comparison to the initial diagnosis 2. characteristics of mutations in HL tumors refractory to brentuximab vedotin 3. characteristics of mutations in HL tumors refractory to nivolumab
Time frame
4 yearsSecondary outcomes
1
In vitro functional characterization of identified DNA variants and/or mutations
In vitro functional characterization of identified DNA variants and/or mutations: 1. variants with unknown impact on classical HL development 2. variants identified as associated with features analyzed in above mentioned goals
Time frame
4 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Interni hematologicka klinika FNKV
Lead sponsor
Charles University, Czech Republic
Collaborator
General University Hospital, Prague
Collaborator
University Hospital Olomouc
Collaborator
University Hospital Hradec Kralove
Collaborator
University Hospital, Motol
Collaborator
Source ClinicalTrials.gov