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Recruiting NCT05231135

A Registry Study on HIV-related Lymphoma

Observational AIDS Related Lymphoma HIV Related Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: AIDS Related Lymphoma, HIV Related Lymphoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany, Netherlands, Spain, United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Characteristics, Treatment and Outcomes of HIV-infected Patients With Malignant Lymphoma: A Registry Study of the European Hematology Association (EHA) Lymphoma Group

Overview

Retrospective und prospective registry on HIV-associated lymphoma. Data on characteristics, type and toxicity of treatment and outcome of patients with HIV-lymphoma will be collected.

Detailed description

To study characteristics, treatment approaches and outcome of HIV-infected patients with malignant lymphoma in the combination antiretroviral therapy (cART) era. HIV-infected persons diagnosed with non-Hodgkin lymphoma or Hodgkin lymphoma will be included. The choice of treatment is not specified by the registry study. However, the type of antineoplastic treatment should follow national or international recommendations and guidelines. Data will be pseudonymized by the data manager of the treating institution. Central data management is located at Red Cross Hospital Munich, Germany.

Primary outcome measures

  • 2-year overall survival (OS) [Time frame: 2 years]
  • 2-year progression-free survival (PFS) [Time frame: 2 years]
Secondary outcome measures (4)
  • Incidence of relapse (IR) [Time frame: 5 years]
  • Non-relapse mortality (NRM) [Time frame: 5 years]
  • 5-year overall survival (OS) [Time frame: 5 years]
  • 5-year progression-free survival (PFS) [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • Histology or cytology proven non-Hodgkin lymphoma or Hodgkin lymphoma
  • HIV-infection at time of lymphoma diagnosis
  • Lymphoma diagnosis since 01.01.2010
  • Adult patients ≥ 18 years
  • Written informed consent

Exclusion criteria

  • HIV-diagnosis > 3 months after the diagnosis of malignant lymphoma
  • Non-Compliance or lack of opportunity for follow-up (for the prospective part of the study)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 2 centers
  • Red Cross Hospital Munich — Munich
  • University Hospital Cologne — Cologne
Spain · 2 centers
  • Hospital de la Santa Creu i Sant Pau — Barcelona
  • Hospital Universitario de Salamanca — Salamanca
Netherlands · 1 center
  • Amsterdam University Medical Centers — Amsterdam
United Kingdom · 1 center
  • University Hospital of Wales — Cardiff

Identifiers

NCT: NCT05231135 · IN03/0121

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗