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NCT Number: NCT06263530

Prognostic Significance of ctDNA in HL

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.

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Key information

Conditions

Prognostic Cancer Model 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

University Hospital Hradec Kralove, Hradec Králové, Czechia

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About this study

Samples of plasma from peripheral blood will be taken for investigational ctDNA examination during the specific timepoints: at diagnosis, after 2 cycles of initial chemotherapy, at the end of chemotherapy, 3 months after radiotherapy, at the diagnosis of the first relapse, after salvage chemotherapy before ASCT, 3 months after ASCT, at the diagnosis of second relapse and every 3 months during brentuximab vedotin treatment or during nivolumab treatment until progression. The buccal swab for germline DNA extraction will be performed at the time of enrollment into the study. Samples of peripheral blood for EBV-DNA analysis will be obtained from the EBV-positive cHL patients to measure EBV load at the same time-points as ctDNA. Microdissected HRS cells from fresh frozen biopsies at the diagnosis and at the relapse will be used for tumor cells next generation sequencing.

Who can participate

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

Inclusion criteria

  • Patients ≥ 18 years with newly histologically confirmed classical Hodgkin lymphoma (cHL) will be enrolled
  • signing the informed consent

Exclusion criteria

  • Pacients without signing the informed consent

Treatment and study plan

Primary outcomes

  1. Identification of tumor specific mutation profiles at dg. of HL based on ctDNA

    Time frame: 4 years

    Identification of tumor specific mutation profiles at diagnosis of classical Hodgkin:

    • age at diagnosis < 60 years in comparison to patients with age at diagnosis 60 years and more
    • EBV negative versus EBV positive cases
    • correlation with the first line treatment outcome lymphoma based on ctDNA analysis with correlation to clinical and pathological characteristics

  2. Quantitative analysis of ctDNA level during the first-line chemotherapy

    Time frame: 4 years

    Quantitative analysis of ctDNA level during the first-line chemotherapy:

    • analysis in relation to the type of chemotherapy: BEACOPP escalated vs ABVD
    • dynamics of ctDNA decline in correlation with treatment response

  3. Identification of tumor specific mutation profiles at relapse of classical HL

    Time frame: 4 years

    Identification of tumor specific mutation profiles at relapse of classical Hodgkin lymphoma:

    • detection of newly developed mutations in comparison to the initial diagnosis
    • characteristics of mutations in HL tumors refractory to brentuximab vedotin
    • characteristics of mutations in HL tumors refractory to nivolumab

Secondary outcomes

  1. In vitro functional characterization of identified DNA variants and/or mutations

    Time frame: 4 years

    In vitro functional characterization of identified DNA variants and/or mutations:

    • variants with unknown impact on classical HL development
    • variants identified as associated with features analyzed in above mentioned goals

Study contacts

Contact information is provided by the study sponsor or research team.

Heidi Mocikova, M.D., Ph.D.

CONTACT

[email protected]

+420267163554

Ondrej Havranek, assoc. prof.

CONTACT

[email protected]

+420325873029

Sponsors and collaborators

Lead sponsor

Interni hematologicka klinika FNKV

Network

Collaborators

  • Charles University, Czech Republic
  • General University Hospital, Prague
  • University Hospital Hradec Kralove
  • University Hospital Olomouc
  • University Hospital, Motol

Registry information

Official study title

Prognostic Significance of Circulating Tumor DNA in Hodgkin Lymphoma

Important dates

Study start
2022
Primary completion
2023
Study completion
2027
First posted
Feb 16, 2024
Registry last updated
Feb 16, 2024

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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