A Registry Study on HIV-related Lymphoma

April 4, 2023 updated by: Prof. Marcus Hentrich, Rotkreuzklinikum München gGmbH

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Cologne, Germany, 50937
        • Recruiting
        • University Hospital Cologne
    • Select One Option
      • Munich, Select One Option, Germany, 80634
        • Recruiting
        • Red Cross Hospital Munich
  • Netherlands
      • Amsterdam, Netherlands
        • Not yet recruiting
        • Amsterdam University Medical Centers
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
      • Salamanca, Spain
        • Recruiting
        • Hospital Universitario de Salamanca
  • United Kingdom
      • Cardiff, United Kingdom
        • Not yet recruiting
        • University Hospital of Wales

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Unselected cohort of adults with HIV-lymphoma

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year overall survival (OS)
Time Frame: 2 years
OS measured from the date of diagnosis to last follow-up or to death from any cause.
2 years
2-year progression-free survival (PFS)
Time Frame: 2 years
PFS calculated from the date of diagnosis to the time of progression, relapse, or death.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-relapse mortality (NRM)
Time Frame: 5 years
Deaths unrelated to lymphoma
5 years
5-year overall survival (OS)
Time Frame: 5 years
OS measured from the date of diagnosis to last follow-up or to death from any cause.
5 years
5-year progression-free survival (PFS)
Time Frame: 5 years
PFS calculated from the date of diagnosis to the time of progression, relapse, or death.
5 years
Incidence of relapse (IR)
Time Frame: 5 years
Based on establised response criteria, e.g. Chesson et al. JCO 2014
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rotkreuzklinikum München gGmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2021

Primary Completion (Anticipated)

August 31, 2024

Study Completion (Anticipated)

August 31, 2029

Study Registration Dates

First Submitted

January 5, 2022

First Submitted That Met QC Criteria

January 28, 2022

First Posted (Actual)

February 9, 2022

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

April 4, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IN03/0121

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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