AIDS Related LymphomaNCT05231135
A Registry Study on HIV-related Lymphoma
An observational study of AIDS Related Lymphoma and HIV Related Lymphoma, run by Rotkreuzklinikum München gGmbH at 6 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AIDS Related Lymphoma, HIV Related Lymphoma
- How many people
- 300 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 25 Aug 2021to 31 Aug 2029
- How long will I take part?
- 6 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Unselected cohort of adults with HIV-lymphoma
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
6 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 4 countries
Germany2 sites, 2 recruiting
- Recruiting
University Hospital Cologne
Cologne, 50937
Kai Hübel, +492214786177, kai.huebel@uk-koeln.de
- Recruiting
Red Cross Hospital Munich
Munich, Select One Option, 80634
Marcus Hentrich, MD, +49 89 1303 4372, marcus.hentrich@swmbrk.de
Spain2 sites, 2 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona
Isabel Regalado Artamendi
IRegalado@santpau.cat
- Recruiting
Hospital Universitario de Salamanca
Salamanca
Miguel Alcoceba, 0034 923 29 11 00 ext. 56610, alcocebasanchez@saludcastillayleon.es
Netherlands1 site, 1 recruiting
- Not yet recruiting
Amsterdam University Medical Centers
Amsterdam
Sanne Tonino, MD, PhD
s.h.tonino@amsterdamumc.nl
United Kingdom1 site, 1 recruiting
- Not yet recruiting
University Hospital of Wales
Cardiff
Emily Hopkins, MD
Emily.Hopkins@wales.nhs.uk
About this study
Official title: Characteristics, Treatment and Outcomes of HIV-infected Patients With Malignant Lymphoma: A Registry Study of the European Hematology Association (EHA) Lymphoma Group
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.
Read the 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.
- Conditions
- AIDS Related Lymphoma, HIV Related Lymphoma
- Keywords
- Malignant lymphoma, HIV-related lymphoma, HIV-associated Hodgkin lymphoma
- Medical subject headings
- Lymphoma, AIDS-Related, Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year overall survival (OS)
OS measured from the date of diagnosis to last follow-up or to death from any cause.
Measured: 2 years
2-year progression-free survival (PFS)
PFS calculated from the date of diagnosis to the time of progression, relapse, or death.
Measured: 2 years
Secondary outcomes (4)
Incidence of relapse (IR)
Based on establised response criteria, e.g. Chesson et al. JCO 2014
Measured: 5 years
Non-relapse mortality (NRM)
Deaths unrelated to lymphoma
Measured: 5 years
5-year overall survival (OS)
OS measured from the date of diagnosis to last follow-up or to death from any cause.
Measured: 5 years
5-year progression-free survival (PFS)
PFS calculated from the date of diagnosis to the time of progression, relapse, or death.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start25 Aug 2021
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AIDS Related LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- Rotkreuzklinikum München gGmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Marcus Hentrich, Rotkreuzklinikum München gGmbH
- Investigators
- Marcus Hentrich, MD, Study chair, Rotkreuzklinikum München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231135
- Sponsor's protocol ID
- IN03/0121
- Status last verified
- Apr 2023
- First submitted
- 5 Jan 2022
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics, Treatment and Outcomes of HIV-infected Patients With Malignant Lymphoma: A Registry Study of the European Hematology Association (EHA) Lymphoma Group
- ClinicalTrials.gov ID
- NCT05231135
- Acronym / sponsor ID
- IN03/0121
- Conditions
- AIDS Related Lymphoma, HIV Related Lymphoma
- Keywords
- Malignant lymphoma, HIV-related lymphoma, HIV-associated Hodgkin lymphoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Rotkreuzklinikum München gGmbHUniversity, hospital or other
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Unselected cohort of adults with HIV-lymphoma
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
2-year overall survival (OS)
Time frame: 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)
Time frame: 2 years
PFS calculated from the date of diagnosis to the time of progression, relapse, or death.
4 secondary outcomes
Incidence of relapse (IR)
Time frame: 5 years
Non-relapse mortality (NRM)
Time frame: 5 years
5-year overall survival (OS)
Time frame: 5 years
5-year progression-free survival (PFS)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
Related trials for AIDS Related Lymphoma
Active, not recruitingPhase 2
Nivolumab With or Without Varlilumab in Treating Patients With Relapsed or Refractory Aggressive B-cell Lymphomas
ALK-Positive Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma Activated B-Cell Type
Active, not recruitingPhase 1/2
Lenalidomide Combined With Modified DA-EPOCH and Rituximab (EPOCH-R2) in Primary Effusion Lymphoma or KSHV-associated Large Cell Lymphoma
Primary Effusion Lymphoma, B-Cell Neoplasm
RecruitingPhase 2
Daratumumab for Relapsed/Refractory Primary Effusion Lymphoma, Plasmablastic Lymphoma, and Multicentric Castleman Disease
Lymphoma, Primary Effusion
RecruitingObservational study
Natural History of KSHV-Associated Multicentric Castleman s Disease
Multicentric Castleman s Disease
RecruitingObservational study
Specimen Collections From Participants With HIV Infection, KSHV Infection, Viral-Related Pre-malignant Lesions and Cancer
HIV, Kaposi's Sarcoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marcus Hentrich, MD study chair
Rotkreuzklinikum München
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AIDS Related Lymphoma and HIV Related Lymphoma, run by Rotkreuzklinikum München gGmbH at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Spain, Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcus Hentrich, MD (+49 89 1303 4372, marcus.hentrich@swmbrk.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year overall survival (OS) (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.