A Registry Study on HIV-related Lymphoma

AIDS Related Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05231135
• Other study ID #: IN03/0121
• Status: Recruiting
• Start date: August 25, 2021
• Est. completion date: August 31, 2029

Study information

• Verified date: April 2023
• Source: Rotkreuzklinikum München gGmbH
• Contact: Marcus Hentrich, MD
• Phone: +49 89 1303 4372
• Email: marcus.hentrich[@]swmbrk.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 31, 2029
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• AIDS Related Lymphoma
• Lymphoma
• Lymphoma, AIDS-Related

Locations

Country	Name	City	State
Germany	University Hospital Cologne	Cologne
Germany	Red Cross Hospital Munich	Munich	Select One Option
Netherlands	Amsterdam University Medical Centers	Amsterdam
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitario de Salamanca	Salamanca
United Kingdom	University Hospital of Wales	Cardiff

Sponsors (1)

Lead Sponsor	Collaborator
Rotkreuzklinikum München gGmbH

Countries where clinical trial is conducted

Germany,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year overall survival (OS)	OS measured from the date of diagnosis to last follow-up or to death from any cause.	2 years
Primary	2-year progression-free survival (PFS)	PFS calculated from the date of diagnosis to the time of progression, relapse, or death.	2 years
Secondary	Incidence of relapse (IR)	Based on establised response criteria, e.g. Chesson et al. JCO 2014	5 years
Secondary	Non-relapse mortality (NRM)	Deaths unrelated to lymphoma	5 years
Secondary	5-year overall survival (OS)	OS measured from the date of diagnosis to last follow-up or to death from any cause.	5 years
Secondary	5-year progression-free survival (PFS)	PFS calculated from the date of diagnosis to the time of progression, relapse, or death.	5 years