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A Registry Study on HIV-related Lymphoma

Sponsor
Rotkreuzklinikum München gGmbH (Other)
Overall Status
Recruiting
CT.gov ID
NCT05231135
Collaborator
(none)
300
Enrollment
6
Locations
96.2
Anticipated Duration (Months)
50
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Characteristics, Treatment and Outcomes of HIV-infected Patients With Malignant Lymphoma: A Registry Study of the European Hematology Association (EHA) Lymphoma Group
    Actual Study Start Date :
    Aug 25, 2021
    Anticipated Primary Completion Date :
    Aug 31, 2024
    Anticipated Study Completion Date :
    Aug 31, 2029

    Outcome Measures

    Primary Outcome Measures

    1. 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. 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

    1. Incidence of relapse (IR) [5 years]

    2. Non-relapse mortality (NRM) [5 years]

      Deaths unrelated to lymphoma

    3. 5-year overall survival (OS) [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) [5 years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Red Cross Hospital Munich Munich Select One Option Germany 80634
    2 University Hospital Cologne Cologne Germany 50937
    3 Amsterdam University Medical Centers Amsterdam Netherlands
    4 Hospital de la Santa Creu i Sant Pau Barcelona Spain
    5 Hospital Universitario de Salamanca Salamanca Spain
    6 University Hospital of Wales Cardiff United Kingdom

    Sponsors and Collaborators

    • Rotkreuzklinikum München gGmbH

    Investigators

    • Study Chair: Marcus Hentrich, MD, Rotkreuzklinikum München

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prof. Marcus Hentrich, Head of the Department of Hematology and Oncology, Rotkreuzklinikum München gGmbH
    ClinicalTrials.gov Identifier:
    NCT05231135
    Other Study ID Numbers:
    • IN03/0121
    First Posted:
    Feb 9, 2022
    Last Update Posted:
    Feb 9, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Prof. Marcus Hentrich, Head of the Department of Hematology and Oncology, Rotkreuzklinikum München gGmbH
    Malignant lymphoma
    HIV-related lymphoma
    HIV-associated Hodgkin lymphoma
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, AIDS-Related

    Study Results

    No Results Posted as of Feb 9, 2022