A Registry Study on HIV-related Lymphoma

Rotkreuzklinikum München gGmbH300 enrolled

Overview

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.

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

300

Conditions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (6)

Red Cross Hospital Munich

Munich, Select One Option, Germany

RECRUITING

University Hospital Cologne

Cologne, Germany

RECRUITING

Amsterdam University Medical Centers

Amsterdam, Netherlands

Outcomes

Primary Outcomes

2-year overall survival (OS)

OS measured from the date of diagnosis to last follow-up or to death from any cause.

Time frame: 2 years

2-year progression-free survival (PFS)

PFS calculated from the date of diagnosis to the time of progression, relapse, or death.

Time frame: 2 years

Secondary Outcomes

Incidence of relapse (IR)

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

Time frame: 5 years

Non-relapse mortality (NRM)

Deaths unrelated to lymphoma

Time frame: 5 years

5-year overall survival (OS)

OS measured from the date of diagnosis to last follow-up or to death from any cause.

Time frame: 5 years

5-year progression-free survival (PFS)

PFS calculated from the date of diagnosis to the time of progression, relapse, or death.

Time frame: 5 years

Central Contacts

Marcus Hentrich, MD

CONTACT

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

Kai Hübel, MD

CONTACT

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

Data from ClinicalTrials.gov

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