NCT05898477

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
26mo left

Started May 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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 Progress58%
May 2023Jul 2028

Study Start

First participant enrolled

May 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 1, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

4.7 years

First QC Date

June 1, 2023

Last Update Submit

January 20, 2026

Conditions

LymphomaHemophagocytic Lymphohistiocytoses

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Hemophagocytic lymphohistiocytosis (HLH) Patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with diagnosis of Hemophagocytic lymphohistiocytosis (HLH)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Conditions

LymphomaLymphohistiocytosis, Hemophagocytic

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHistiocytosis, Non-Langerhans-CellHistiocytosis

Study Officials

  • Gaurav Goyal, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaurav Goyal, MD

CONTACT

205-934-1816ggoyal@uabmc.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 1, 2023

First Posted

June 12, 2023

Study Start

May 1, 2023

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

January 22, 2026

Record last verified: 2026-01

Locations

US(1)