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NCT02823327

Clinical and Genomic Factors for Prognosis of AIDS Primary Effusion Lymphoma

Terminated Results posted Last updated 11 May 2025
What this trial tests

trial testing Laboratory Biomarker Analysis in AIDS-Related Primary Effusion Lymphoma in 25 participants. Terminated before completion.

Timeline
11 October 2016
Primary endpoint
3 February 2023
3 February 2023

Quick facts

Lead sponsorAIDS Malignancy Consortium
StatusTerminated
Study typeOBSERVATIONAL
Enrollment25
Start date11 October 2016
Primary completion3 February 2023
Estimated completion3 February 2023
Sites6 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

AIDS Malignancy Consortium

Who can join

18 and older, any sex, with AIDS-Related Primary Effusion Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Differential Gene Expression Profile by RNA-Seq or GeneChip Assays Primary · baseline

The resultant data will be a subset of the whole analysis population due to RNAseq data availability. It will be assessed for quality, normalized, and then analyzed for differential gene expression. The Nanostring software nSolver will be used to do quality control, background subtraction, normalization, and analysis of the differential expression for RNA-sequencing data. Lastly, bioinformatic analysis approaches will be used to help make sense of possible biological links between the genes found to be differentially expressed between the sample groups that may be of prognostic significance. 1

GroupValue95% CI
Survival Less Than 2 Years With Available RNAseq Data4
Survival More Than or Equal to 2 Years With Available RNAseq Data15
Response Rates Primary · Up to 1 year

The number of participants for this outcome measure is 25 participants with baseline characteristics and response evaluation. Since this was a retrospective study, response criteria were not defined. Response determinations as recorded in the medical record by the treating physician were abstracted on each participant for data analysis. Response rates will be reported with 95% confidence intervals (binomial distribution). Descriptive statistics will be used to summarize baseline clinical, histological, and viral characteristics.

Complete response
GroupValue95% CI
Survival Less Than 2 Years1
Survival More Than or Equal to 2 Years13
Partial response
GroupValue95% CI
Survival Less Than 2 Years2
Survival More Than or Equal to 2 Years2
Stable disease
GroupValue95% CI
Survival Less Than 2 Years2
Survival More Than or Equal to 2 Years2
Progression
GroupValue95% CI
Survival Less Than 2 Years3
Survival More Than or Equal to 2 Years3
Survival Status at 2 Years Primary · At 2 years post diagnosis

Survival duration will be determined using the elapsed time between the date of PEL diagnosis and the last follow-up date or the date of death.

Hispanic
GroupValue95% CI
Survival Less Than 2 Years2
Survival More Than or Equal to 2 Years5
Non-Hispanic
GroupValue95% CI
Survival Less Than 2 Years6
Survival More Than or Equal to 2 Years12
White
GroupValue95% CI
Survival Less Than 2 Years5
Survival More Than or Equal to 2 Years9
Non-White
GroupValue95% CI
Survival Less Than 2 Years3
Survival More Than or Equal to 2 Years8
EPOCH treatment
GroupValue95% CI
Survival Less Than 2 Years4
Survival More Than or Equal to 2 Years13
Non-EPOCH treatment
GroupValue95% CI
Survival Less Than 2 Years4
Survival More Than or Equal to 2 Years4
Stage I-III
GroupValue95% CI
Survival Less Than 2 Years2
Survival More Than or Equal to 2 Years6
Stage IV
GroupValue95% CI
Survival Less Than 2 Years6
Survival More Than or Equal to 2 Years11

Sponsor's own description

This research trial studies clinical factors and gene expression analysis for prognosis in tissue samples from patients with acquired immune deficiency syndrome (AIDS)-related primary effusion lymphoma. Gathering health information over time and studying samples of tissue from patients in the laboratory may help doctors learn about the prognosis of patients with AIDS-related primary effusion lymphoma.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Activity of brentuximab vedotin in AIDS-related primary effusion lymphoma.
    Chang VA, Wang HY, Reid EG. · · 2019 · cited 10× · PMID 30837213 · DOI 10.1182/bloodadvances.2018026351

Verify or expand the search:

Other trials of Laboratory Biomarker Analysis

Trials testing the same drug.

Other recruiting trials for AIDS-Related Primary Effusion Lymphoma

Currently open trials in the same condition.

Other AIDS Malignancy Consortium trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02823327.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing