Describing Treatment Outcomes and Responses in Lymphoma-associated Hemophagocytic Lymphohistiocytosis

January 20, 2026 updated by: Gaurav Goyal, University of Alabama at Birmingham
The purpose of the study is to describe Hemophagocytic lymphohistiocytosis (HLH) in patients with lymphoma to identify possible therapeutic strategies to improve overall survival of the patients with lymphoma associated hemophagocytic lymphohistiocytosis.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Retrospective, multi-institutional study focused on describing the clinical features, laboratory parameters, treatments, and outcomes among individuals presenting with HLH in the setting of a lymphoma

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with diagnosis of Hemophagocytic lymphohistiocytosis (HLH)

Description

Inclusion Criteria:

  • Patients with lymphoma that are fulfilling at least one of the following:

A. Meeting 5 of 8 HLH-2004 diagnostic criteria OR B. Are OHI index positive (sCD25>3,900 U/mL and ferritin>1,000 ng/mL)

Exclusion Criteria:

  • Patients developing HLH> 1 month after lymphoma diagnosis (for aggressive lymphomas)
  • Patients with incomplete treatment and response documentation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Hemophagocytic lymphohistiocytosis (HLH) Patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the factors predicting 180 days overall survival of patients with cancer that are HLH-2004/OHI+
Time Frame: The participant's survival would be assessed at 180 days from the malignancy diagnosis
The investigators will gather data on different treatments received, time to treatment, and other factors and determine which is associated with survival.
The participant's survival would be assessed at 180 days from the malignancy diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Gaurav Goyal, MD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

June 1, 2023

First Submitted That Met QC Criteria

June 1, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300010383

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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