Prognostic Significance of Circulating Tumor DNA in Hodgkin Lymphoma
Status: Recruiting
Study Type: Observational
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
View:
• Patients ≥ 18 years with newly histologically confirmed classical Hodgkin lymphoma (cHL) will be enrolled
• signing the informed consent
Contact Information
Primary
Heidi Mocikova, M.D., Ph.D.
heidi.mocikova@fnkv.cz
+420267163554
Backup
Ondrej Havranek, assoc. prof.
ondrej.havranek@lf1.cuni.cz
+420325873029
Time Frame
Start Date: 2022-01-02
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 500
Treatments
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
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).
Related Therapeutic Areas
Sponsors
Collaborators: General University Hospital, Prague, University Hospital Hradec Kralove, Charles University, Czech Republic, University Hospital Olomouc, University Hospital, Motol
Leads: Interni hematologicka klinika FNKV