A Registry Study on HIV-related Lymphoma

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05231135

Enrollment

300

Registered

2022-02-09

Start date

2021-08-25

Completion date

2029-08-31

Last updated

2023-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIDS Related Lymphoma, HIV Related Lymphoma

Keywords

Malignant lymphoma, HIV-related lymphoma, HIV-associated Hodgkin lymphoma

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

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

Countries

Germany, Netherlands, Spain, United Kingdom

Contacts

Primary ContactMarcus Hentrich, MD

marcus.hentrich@swmbrk.de+49 89 1303 4372

Backup ContactKai Hübel, MD

kai.huebel@uk-koeln.de+49 221 478 86177

Outcome results