NCT02815137

Brief Summary

The purpose of this study is to determine if the XPO1 E571K mutation could be used as molecular residual disease biomarker in classical Hodgkin's lymphoma. To determine the interest of the mutation assessment by digital Polymerase Chain Reaction, sensitivity and specificity after 2 courses of chemotherapy (C2) will be compared with the deltaSUVmax determined by Positron Emission Tomography after C2 and at end of treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2021

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2025

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

5.5 years

First QC Date

June 13, 2016

Last Update Submit

December 29, 2025

Conditions

Classical Hodgkin Lymphoma

Keywords

Digital PCRclassicalHodgkin Lymphomamutation

Outcome Measures

Primary Outcomes (1)

  • If the mutation can be used as a molecular minimal residual disease biomarker

    Comparison of the sensitivity and specificity of the detection of the mutation between delta Standard Uptake Value max (SUV max) determined by PET after two courses of chemotherapy

    56 days

Secondary Outcomes (3)

  • Kinetic of allele frequency decrease

    224 days

  • Variation of Deauville scale

    224 days

  • Progression-free survival

    2 years

Study Arms (1)

XPO1 E571K mutation detection

OTHER

Determination of mutation of XPO1571K in patient with classical hodgkin Lymphoma by digital PCR on blood samples and biopsy

Other: Digital Polymerase Chain Reaction

Interventions

Digital Polymerase Chain ReactionOTHER

Determination of mutation of XPO1 E571K by digital PCR in blod sample of patient with classical hodgkin lymphoma

XPO1 E571K mutation detection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Pathologically confirmed, recent diagnosis of classical Hodgkin Lymphoma
  • treatment planned with Adriamycin Bleamycin Vinblastine Dacarbazine (ABVD) or Bleomycin Etoposide Adriamycin Cyclophosphamide Vincristine Procarbazine Prednisone (BEACOPP) regimen (and radiotherapy if applicable)
  • all stages (Ann Arbor I - IV)
  • Written informed consent
  • Patient affiliated or beneficiary of a benefit system
  • untreated patient (no corticosteroids or chemotherapy)

You may not qualify if:

  • No informed consent
  • Treatment by ABVD or BEACOPP not indicated
  • Previously treated Hodgkin lymphoma (including corticosteroids)
  • Patients who are pregnant or lactating
  • Active Hepatitis B or Hepatitis C infection
  • Known human immunodeficiency virus (HIV) infection - Patient with no social protection
  • Patient under tutorship or curatorship
  • Patient not affiliated of beneficiary of a benefit system
  • Medical contraindication to PET/CT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Henri Becquerel

Rouen, 76000, France

Location

Related Publications (1)

  • Camus V, Viennot M, Lequesne J, Viailly PJ, Bohers E, Bessi L, Marcq B, Etancelin P, Dubois S, Picquenot JM, Veresezan EL, Cornic M, Burel L, Loret J, Becker S, Decazes P, Lenain P, Lepretre S, Lemasle E, Lanic H, Menard AL, Contentin N, Tilly H, Stamatoullas A, Jardin F. Targeted genotyping of circulating tumor DNA for classical Hodgkin lymphoma monitoring: a prospective study. Haematologica. 2021 Jan 1;106(1):154-162. doi: 10.3324/haematol.2019.237719.

    PMID: 32079702DERIVED

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Fabrice JARDIN, PUPH

    Centre Henri Becquerel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2016

First Posted

June 28, 2016

Study Start

June 1, 2016

Primary Completion

December 7, 2021

Study Completion

January 8, 2025

Last Updated

January 2, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)