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| Name | Class |
|---|---|
| Charles University, Czech Republic | OTHER |
| General University Hospital, Prague | OTHER |
| University Hospital Olomouc | OTHER |
| University Hospital Hradec Kralove |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard first line treatment, stages I or II without risk factors | Standard first-line treatment that includes 2 cycles of ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) and involved site radiotherapy of 20 Gy in early clinical stages I or II without risk factors. | ||
| Patients < 60 years, stages I or II and 1 risk factor | Patients below 60 years in intermediate clinical stages I or II with at least one risk factor are treated with 2 cycles of BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone) escalated and 2 cycles of ABVD in PET-4 negative cases. Involved site radiotherapy of 30 Gy is indicated in PET-4 positive patients with intermediate stages after chemotherapy. | ||
| Patients < 60 years, stages III or IV with MMT and/or EN disease | Patients in advanced stages III or IV and patients in stage IIB with massive mediastinal tumor and/or extranodal disease are treated with 4 or 6 cycles of BEACOPP escalated based on PET-2 negativity or positivity. | ||
| Elderly patients ≥ 60 years and 1 risk factor | Elderly patients in intermediate stages are treated with 2 cycles of ABVD and 2 cycles of AVD without bleomycin and involved site radiotherapy of 30 Gy. | ||
| Elderly patients ≥ 60 years, stages III or IV | Elderly patients in advanced stages are treated with 2 cycles of ABVD and 4 cycles of AVD without bleomycin |
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| Measure | Description | Time Frame |
|---|---|---|
| Identification of tumor specific mutation profiles at dg. of HL based on ctDNA | Identification of tumor specific mutation profiles at diagnosis of classical Hodgkin:
| 4 years |
| Quantitative analysis of ctDNA level during the first-line chemotherapy | Quantitative analysis of ctDNA level during the first-line chemotherapy:
| 4 years |
| Identification of tumor specific mutation profiles at relapse of classical HL | Identification of tumor specific mutation profiles at relapse of classical Hodgkin lymphoma:
| 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| In vitro functional characterization of identified DNA variants and/or mutations | In vitro functional characterization of identified DNA variants and/or mutations:
| 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heidi Mocikova, M.D., Ph.D. | Contact | +420267163554 | heidi.mocikova@fnkv.cz | |
| Ondrej Havranek, assoc. prof. | Contact | +420325873029 | ondrej.havranek@lf1.cuni.cz |
| Name | Affiliation | Role |
|---|---|---|
| Heidi Mocikova, M.D., Ph.D. | Faculty Hospital Kralovske Vinohrady | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Hradec Kralove | Recruiting | Hradec Králové | 50005 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25629123 | Background | Dusek L, Majek O. Editorial. Klin Onkol. 2014;27 Suppl 2:3. No abstract available. | |
| 25493581 | Background | Mocikova H, Sykorova A, Stepankova P, Markova J, Michalka J, Kral Z, Buresova L, Belada D. [Treatment and prognosis of relapsed or refractory Hodgkin lymphoma patients ineligible for stem cell transplantation]. Klin Onkol. 2014;27(6):424-8. doi: 10.14735/amko2014424. Czech. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 30, 2023 | Feb 7, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 30, 2023 | Feb 7, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| OTHER |
| University Hospital, Motol | OTHER |
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Identification of tumor specific mutation profiles at diagnosis of classical Hodgkin lymphoma Quantitative analysis of ctDNA level during the first-line chemotherapy Identification of tumor specific mutation profiles at relapse of classical Hodgkin lymphoma In vitro functional characterization of identified DNA variants and/or mutations
| Relapsed patients up to 65 years | The treatment for patients in relapse up to the age of 65 years is two cycles of platinum based salvage chemotherapy: cisplatin, cytarabine and dexamethasone (DHAP) or ifosfamide, carboplatin, etoposide (ICE) followed by high- dose chemotherapy and autologous stem cell transplantation (ASCT). |
| University Hospital Olomouc | Recruiting | Olomouc | 77520 | Czechia |
|
| University Hospital Kralovske Vinohrady | Recruiting | Prague | 10034 | Czechia |
|
| Charles University | Active, not recruiting | Prague | 12108 | Czechia |
| General University Hospital | Recruiting | Prague | 12808 | Czechia |
|
| 32050133 | Background | Sykorova A, Mocikova H, Lukasova M, Koren J, Stepankova P, Prochazka V, Belada D, Klaskova K, Gaherova L, Chroust K, Buresova L, Markova J; Czech Hodgkin's Lymphoma Study Group. Outcome of elderly patients with classical Hodgkin's lymphoma. Leuk Res. 2020 Mar;90:106311. doi: 10.1016/j.leukres.2020.106311. Epub 2020 Jan 24. |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |