Describing Treatment Outcomes and Responses in Lymphoma-a... | NCT05898477

Studies
Describing Treatment Outcomes and Responses in Lymphoma-associated Hemophagocytic Lymphohistiocytosis

NCT05898477

Sponsor

University of Alabama at Birmingham

Status

Recruiting

Last Update Posted

Jan 22, 2026Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Lymphoma
Hemophagocytic Lymphohistiocytoses

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2023Actual

Primary Completion Date

Jan 2028Estimated

Completion Date

Jul 2028Estimated

First Submitted Date

Jun 1, 2023

First Submission Date that Met QC Criteria

Jun 1, 2023

First Posted Date

Jun 12, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2026

Last Update Posted Date

Jan 22, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gaurav Goyal, Principal Investigator, University of Alabama at BirminghamPrincipal Investigator

Lead Sponsor

University of Alabama at BirminghamOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Label	Type	Description	Intervention Names
Hemophagocytic lymphohistiocytosis (HLH) Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the factors predicting 180 days overall survival of patients with cancer that are HLH-2004/OHI+	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with diagnosis of Hemophagocytic lymphohistiocytosis (HLH)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gaurav Goyal, MD	Contact	205-934-1816		ggoyal@uabmc.edu

Overall Officials

Name	Affiliation	Role
Gaurav Goyal, MD	University of Alabama at Birmingham	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham	Recruiting	Birmingham	Alabama	35294	United States

Condition Browse Module

MeSH Terms

ID	Term
D008223	Lymphoma
D051359	Lymphohistiocytosis, Hemophagocytic

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided