NCT05231135

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
41mo left

Started Aug 2021

Longer than P75 for all trials

Geographic Reach
4 countries

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Aug 2021Aug 2029

Study Start

First participant enrolled

August 25, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 9, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2029

Expected
Last Updated

April 6, 2023

Status Verified

April 1, 2023

Enrollment Period

3 years

First QC Date

January 5, 2022

Last Update Submit

April 4, 2023

Conditions

Keywords

Malignant lymphomaHIV-related lymphomaHIV-associated Hodgkin lymphoma

Outcome Measures

Primary Outcomes (2)

  • 2-year overall survival (OS)

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

    2 years

  • 2-year progression-free survival (PFS)

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

    2 years

Secondary Outcomes (4)

  • Incidence of relapse (IR)

    5 years

  • Non-relapse mortality (NRM)

    5 years

  • 5-year overall survival (OS)

    5 years

  • 5-year progression-free survival (PFS)

    5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Unselected cohort of adults with HIV-lymphoma

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Red Cross Hospital Munich

Munich, Select One Option, 80634, Germany

RECRUITING

University Hospital Cologne

Cologne, 50937, Germany

RECRUITING

Amsterdam University Medical Centers

Amsterdam, Netherlands

NOT YET RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

RECRUITING

Hospital Universitario de Salamanca

Salamanca, Spain

RECRUITING

University Hospital of Wales

Cardiff, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Lymphoma, AIDS-RelatedLymphoma

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Marcus Hentrich, MD

    Rotkreuzklinikum München

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
6 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department of Hematology and Oncology

Study Record Dates

First Submitted

January 5, 2022

First Posted

February 9, 2022

Study Start

August 25, 2021

Primary Completion

August 31, 2024

Study Completion (Estimated)

August 31, 2029

Last Updated

April 6, 2023

Record last verified: 2023-04

Locations