European Project for ctDNA Detection as a Biomarker for Non-invasive Therapy Monitoring in Paediatric Classical Hodgkin Lymphoma

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

Classical Hodgkin lymphoma (cHL) accounts for 15% of all cases of cancer in children and adolescents and represents the first cause of cancer during adolescence. Combined multi-modal chemotherapy and modern radiation techniques have transformed cHL in a highly curable cancer. However, up to 10-15% of patients still experience recurrent or primary refractory disease. Thus, there is an unmet need for unravelling the underlying mechanisms of treatment failure and refractoriness in paediatric cHL. Further refinements of treatment strategy are still needed to improve treatment results both in relapse and refractory (R/R) patients and to reduce long-term morbidity and mortality treatment related. Therefore, two main objectives arise: to improve early detection of patients with a high relapse risk to potentially intensify the first line treatment and to better identify low risk patients to further reduce the treatment burden in this good-prognostic population. Initial disease stratification and long-term outcome predictions remain a challenging issue in the field. PET/CT is currently the reference imaging method for initial staging and improves detection of extra nodal disease. None of previous prognostic factors accurately identify patients who will respond adequately and therefore limit the ability to identify patients who should require treatment that is more intensive or new therapeutic approaches like immunotherapy. Taken together, these data emphasize a clear unmet need in the field of cHL. We aim to develop a biomarker tool, which could sharpen the initial risk stratification, improve the assessment of disease evaluation during the treatment and beyond and facilitate the detection of relapse. Over the past decade, as in other malignancies the potential of quantification of circulating tumour DNA (ctDNA) or liquid biopsy, in circulating cell-free DNA (cfDNA) that comprises DNA fragments released from apoptotic or necrotic cells into circulation, has emerged as a promising tool for diagnosis and exploration of the genetic landscape associated with HRS and for response evaluation. Experiences of ctDNA in cHL was first reported in adult cHL. These previous studies paved the way for ctDNA implementation in cHL. First, they contributed to confirm the feasibility to use ctDNA in the detection of tumor-associated mutation. Using paired samples of ctDNA and tumor DNA from HRS cells obtained by microdissection they confirmed the consistent correlation between these two methods. Second, they highlighted the potential role of ctDNA as a surrogate marker for tumor baseline assessment and more importantly for interim evaluation reporting an excellent correlation between the PET/CT result and the presence or the absence of ctDNA after 2 cycles of chemotherapy. Furthermore, Sobesky et al. previously reported that cured patients who were inconsistently judged as interim PET/CT-positive had a more than 2-log drop in ctDNA, whereas relapsing patients who were inconsistently judged as interim PET/CT negative had a less than 2-log drop in ctDNA. These data suggest that ctDNA could be a relevant adjunct to conventional PET/CT approach.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed classical Hodgkin lymphoma (cHL)

Children and young adults under the age of 25 years old

Signature of informed consent by the patient and/or holders of parental authority (depending on the age of the patient)

Affiliation to a social security scheme or being beneficiary of such a scheme

Disqualifiers

Previous treatment with chemotherapy or radiotherapy for another cancer

Pretreatment of Hodgkin lymphoma (except one treatment with corticosteroid for 7 to 10 days for large or compressive mediastinal tumors).

Diagnosis of nodular lymphocyte predominant Hodgkin lymphoma (NLPHL)

Other concomitant malignancies • Residence outside participating countries in for which long-term follow-up cannot be ensured

Trial population

Children and adolescents newly diagnosed with Hodgkin lymphoma treated in participating pediatric oncology centers. Patients will be enrolled at diagnosis and followed prospectively for relapse outcomes

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

400 Participants
are grouped into 1 trial group
Group A: Main Cohort

Trial outcomes

Primary outcomes

1

Relapse-Free Survival (RFS) at 2 and 5 years based on ctDNA status at diagnosis

Time from initial diagnosis to first relapse or death from any cause. Patients will be stratified by ctDNA status at diagnosis, including quantitative burden and mutation profiles.

Time frame
2 years and 5 years

Secondary outcomes

1

Diagnostic performance of ctDNA after 1 cycle of chemotherapy

Sensitivity, specificity, PPV and NPV of ctDNA detection compared to PET/CT metrics (deltaSUVmax, Deauville score).

Time frame
At Day 28 (post first OEPA cycle)
2

Diagnostic performance of ctDNA after 2 cycles of chemotherapy

Sensitivity, specificity, PPV and NPV of ctDNA detection compared to PET/CT metrics (deltaSUVmax, Deauville score).

Time frame
At Day 56 (post second OEPA cycle)
3

Diagnostic performance of ctDNA at end of treatment

Sensitivity, specificity, PPV and NPV of ctDNA detection at end of treatment compared to PET/CT evaluation.

Time frame
At treatment completion (approximately Month 6)
4

Molecular landscape of ctDNA at relapse

Mutation profiling of ctDNA in patients with relapsed/refractory cHL and analysis of association between mutation patterns and treatment outcome.

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Centre de Lutte contre le Cancer Henri Becquerel, Rouen, France

Collaborator

University Medical Center of Giessen, Germany

Collaborator