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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03037177
Other study ID # 69HCL16_0721
Secondary ID
Status Completed
Phase N/A
First received November 4, 2016
Last updated January 27, 2017
Start date January 2013
Est. completion date June 2016

Study information

Verified date October 2016
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Mediastinal grey zone lymphoma, B cell lymphomas with intermediate features between classical Hodgkin lymphoma and primary mediastinal B cell lymphoma, are not well described in the literature. Investigators report the clinical characteristics and outcomes of a large retrospective series of 99 cases centrally reviewed by a panel of hematopathologists, with a consensus established for the diagnosis.


Recruitment information / eligibility

Status Completed
Enrollment 99
Est. completion date June 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- cases with an intermediate morphology and phenotype between CHL and PMBCL were included after central pathological review

Exclusion Criteria:

- Cases of CHL with partial CD20 expression or low expression in tumoral cells were excluded and considered as CD20-positive CHL

- Exclusion of sequential form patients (with a diagnostic biopsy of PMBCL and a relapse biopsy of CHL or vise-versa) as they represent a biases for statistical analysis.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Centre hospitalier Lyon sud Pierre Bénite Rhône Alpes

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary EFS in the global population of GZL Event-free survival (EFS) was calculated from the date of diagnosis to the date of progression, a change of therapy that was not initially scheduled (radiotherapy, high-dose therapy with autologous stem cell transplantation and other unplanned treatments) or death from any cause. EFS: Event Free Survival from date of randomization until the date of first documented progression, up to 130 months