Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05231135

A Registry Study on HIV-related Lymphoma

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

AIDS Related Lymphoma HIV Related Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, AIDS-Related Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Red Cross Hospital Munich, Munich, Select One Option, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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. 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.

Secondary outcomes

  1. Incidence of relapse (IR)

    Time frame: 5 years

    Based on establised response criteria, e.g. Chesson et al. JCO 2014

  2. Non-relapse mortality (NRM)

    Time frame: 5 years

    Deaths unrelated to lymphoma

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kai Hübel, MD

CONTACT

[email protected]

+49 221 478 86177

Marcus Hentrich, MD

CONTACT

[email protected]

+49 89 1303 4372

Sponsors and collaborators

Lead sponsor

Rotkreuzklinikum München gGmbH

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2029
First posted
Feb 9, 2022
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.