Prospective Validation of the OHI Index (HLH)

May 8, 2025 updated by: Meir Medical Center

A Prospective Study to Validate the Prognostic Power of the Optimized HLH Inflammatory (OHI) Index

Hemophagocytic lymphohistiocytosis (HLH) associated with hematologic malignancies (HM-HLH) is a syndrome with an abysmal prognosis (10-30% 5 years overall survival). The investigators have recently established an improved diagnostic and prognostic index for HM-HLH, termed the Optimized HLH Inflammatory (OHI) index. The OHI index is comprised of the combined elevation of soluble CD25 (sCD25) > 3,900 U/mL and ferritin >1,000 ng/mL . However, the true incidence and outcomes of HLH/OHI+ in an unselected cohort are unknown, and so is the mechanism of HM-HLH.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The investigators will enroll patients with new/transformed hematologic malignancies. The investigators will follow the patients until the end of the study, report their survival at one year and examine their prognosis.

Study Type

Observational

Enrollment (Estimated)

300

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 Contact Backup

Study Locations

  • Israel
      • Kfar Saba, Israel, 4428164
        • Recruiting
        • Meir Medical Center
        • Contact:
      • Petach Tikva, Israel, 49100
        • Recruiting
        • Rabin Medical Center
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Male and females with new diagnosis/transformation/reactivation of hematologic malignancies

Description

Inclusion Criteria:

  • Patients with hematologic malignancies
  • At least 18 years old

Exclusion Criteria:

  • Prior recent treatment (chemotherapy/ other cytoreductive therapies in the last month)

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
OHI+ patients
Adult patients with hematologic malignancies that have sCD25>3,900 U/mL and ferritin >1,000 ng/mL
OHI- patients
Adult patients with hematologic malignancies, with sCD25>3,900 U/mL and/or ferritin < 1,000 ng/mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess 365 days mortality of OHI+ and OHI- patients
Time Frame: Mortality rate one year from OHI assessment
The investigators will use Kaplan-Meier curves to compare survival between OHI+ and OHI- patients
Mortality rate one year from OHI assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the incidence of OHI+ patients in our cohort
Time Frame: The investigators will assess the incidence after three years of enrollment
The investigators will assess the incidence of OHI+ within our cohort (OHI+/total patients enrolled)
The investigators will assess the incidence after three years of enrollment

Collaborators and Investigators

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

Sponsor

Meir Medical Center

Collaborators

Rabin Medical Center
Children's Hospital Medical Center, Cincinnati
Sheba Medical Center
Schneider Children's Medical Center, Israel

Investigators

  • Principal Investigator: Adi Zoref-Lorenz, Meir Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 3, 2021

Primary Completion (Estimated)

March 3, 2030

Study Completion (Estimated)

March 3, 2030

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

May 21, 2023

First Posted (Actual)

May 31, 2023

Study Record Updates

Last Update Posted (Actual)

May 13, 2025

Last Update Submitted That Met QC Criteria

May 8, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0321-19-MMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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