NCT06263530|RecruitingDMC
Prognostic Significance of ctDNA in HL
Prognostic Significance of Circulating Tumor DNA in Hodgkin Lymphoma
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Prognostic Significance of Circulating Tumor DNA in Hodgkin Lymphoma
Sponsor study identifier
observational
500
1 country
5
Study Start
January 2, 2022
Actual (reported)Primary Completion
December 31, 2023
Actual (reported)Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2, 2022
Actual (reported)November 14, 2023
Actual (reported)December 31, 2023
Actual (reported)February 16, 2024
Actual (reported)December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
4 years
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
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: 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
4 years
In vitro functional characterization of identified DNA variants and/or mutations
4 years
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 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 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 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 in advanced stages are treated with 2 cycles of ABVD and 4 cycles of AVD without bleomycin
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.
University Hospital Hradec Kralove
Hradec Králové, 50005, Czechia
University Hospital Olomouc
Olomouc, 77520, Czechia
Dusek L, Majek O. Editorial. Klin Onkol. 2014;27 Suppl 2:3. No abstract available.
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.
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.
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
Heidi Mocikova, M.D., Ph.D.
Faculty Hospital Kralovske Vinohrady
First Submitted
November 14, 2023
First Posted
February 16, 2024
Study Start
January 2, 2022
Actual (reported)Primary Completion
December 31, 2023
Actual (reported)Nutrition Assessment in Advanced Cancer Patients
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).
Contact the study team to confirm eligibility.
University Hospital Kralovske Vinohrady
Prague, 10034, Czechia
Charles University
Prague, 12108, Czechia
General University Hospital
Prague, 12808, Czechia
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 16, 2024
Record last verified: 2024-02
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