Prognostic Cancer ModelNCT06263530
Prognostic Significance of ctDNA in HL
An observational study of Prognostic Cancer Model, run by Interni hematologicka klinika FNKV at 5 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prognostic Cancer Model
- Type of treatment
- Injection or infusion
- How many people
- 500 participants
- Where
- 5 sitesCzechia
- Study dates
- 2 Jan 2022to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study 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.
Who may be able to join
- Patients ≥ 18 years with newly histologically confirmed classical Hodgkin lymphoma (cHL) will be enrolled
- signing the informed consent
Who cannot join
- Pacients without signing the informed consent
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Czechia5 sites, 4 recruiting
- Recruiting
University Hospital Hradec Kralove
Hradec Králové, 50005
Alice Sykorova, M.D., Ph.D., +420495 832 866, alice.sykorova@fnhk.cz
- Recruiting
University Hospital Olomouc
Olomouc, 77520
Vit Prochazka, prof. M.D., +420588 442 878, prochazv@fnol.cz
- Recruiting
University Hospital Kralovske Vinohrady
Prague, 10034
Heidi Mocikova, M.D., Ph.D., +420267163554, heidi.mocikova@fnkv.cz
Katerina Klaskova, Ing., +420267162880, katerina.klaskova@fnkv.cz
- Active, not recruiting
Charles University
Prague, 12108
- Recruiting
General University Hospital
Prague, 12808
Jan Koren, M.D., +420224962541, jan.koren@vfn.cz
About this study
Official title: Prognostic Significance of Circulating Tumor DNA in Hodgkin Lymphoma
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.
Read the detailed description
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.
- Conditions
- Prognostic Cancer Model
- Keywords
- Hodgkin lymphoma, circulating tumor DNA, next generation sequencing
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of tumor specific mutation profiles at dg. of HL based on ctDNA
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
Measured: 4 years
Quantitative analysis of ctDNA level during the first-line chemotherapy
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
Measured: 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:
- 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
Measured: 4 years
Secondary outcomes (1)
In vitro functional characterization of identified DNA variants and/or mutations
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
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start2 Jan 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prognostic Cancer ModelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Interni hematologicka klinika FNKV
- Sponsor type
- Research network
- Collaborators
- Charles University, Czech Republic, General University Hospital, Prague, University Hospital Olomouc, University Hospital Hradec Kralove, University Hospital, Motol
- Responsible party
- Sponsor
- Investigators
- Heidi Mocikova, M.D., Ph.D., Study chair, Faculty Hospital Kralovske Vinohrady
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263530
- Sponsor's protocol ID
- NU22-03-00182
- Status last verified
- Feb 2024
- First submitted
- 14 Nov 2023
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dusek L, Majek O. Editorial. Klin Onkol. 2014;27 Suppl 2:3. No abstract available.
PubMed 25629123Mocikova 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.
PubMed 25493581Sykorova 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.
PubMed 32050133
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Significance of Circulating Tumor DNA in Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT06263530
- Acronym / sponsor ID
- NU22-03-00182
- Conditions
- Prognostic Cancer Model
- Keywords
- Hodgkin lymphoma, circulating tumor DNA, next generation sequencing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Interni hematologicka klinika FNKVResearch network
- Collaborators
- Charles University, Czech Republic, General University Hospital, Prague, University Hospital Olomouc, University Hospital Hradec Kralove, University Hospital, Motol
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (2 listed)
- Patients ≥ 18 years with newly histologically confirmed classical Hodgkin lymphoma (cHL) will be enrolled
- signing the informed consent
Key exclusion criteria (1 listed)
- Pacients without signing the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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: 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
Quantitative analysis of ctDNA level during the first-line chemotherapy
Time frame: 4 years
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
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: 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
1 secondary outcome
In vitro functional characterization of identified DNA variants and/or mutations
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Background: PubMed 25629123Dusek L, Majek O. Editorial. Klin Onkol. 2014;27 Suppl 2:3. No abstract available.
- Background: PubMed 25493581Mocikova 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.
- Background: PubMed 32050133Sykorova 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heidi Mocikova, M.D., Ph.D. study chair
Faculty Hospital Kralovske Vinohrady
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prognostic Cancer Model, run by Interni hematologicka klinika FNKV at 5 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heidi Mocikova, M.D., Ph.D. (+420267163554, heidi.mocikova@fnkv.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of tumor specific mutation profiles at dg. of HL based on ctDNA (time frame: 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06263530, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.