A Registry Study on HIV-related Lymphoma

Recruiting

• Conditions: HIV Related Lymphoma; AIDS Related Lymphoma

• Registration Number: NCT05231135
• Lead Sponsor: Rotkreuzklinikum München gGmbH

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.

Study Timeline

• Study Start: 2021-08-25
• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-01-28
• Study First Posted: 2022-02-09
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-04-06
• Primary Completion: 2024-08-31
• Study Completion: 2029-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (6)

Amsterdam University Medical Centers; 🇳🇱 Amsterdam, Netherlands

Red Cross Hospital Munich; 🇩🇪 Munich, Select One Option, Germany

University Hospital Cologne; 🇩🇪 Cologne, Germany

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Universitario de Salamanca; 🇪🇸 Salamanca, Spain

University Hospital of Wales; 🇬🇧 Cardiff, United Kingdom