Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05882175

Prospective Validation of the 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

HLH Hematologic Diseases Hematologic Malignancy Hematologic Neoplasms Hemic and Lymphatic Diseases Hemophagocytic Lymphohistiocytoses Hemophagocytic Syndrome Histiocytosis Histiocytosis, Non-Langerhans-Cell Lymphatic Diseases Lymphohistiocytosis, Hemophagocytic Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Meir Medical Center, Kfar Saba, Israel

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with hematologic malignancies
  • At least 18 years old

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Adi Zoref Lorenz, MD

CONTACT

[email protected]

513 6525610

Noa Rabinowicz, PhD

CONTACT

[email protected]

+972-54-4864564 ext. +972-9-7472398

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Collaborators

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

Registry information

Official study title

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

Acronym: HLH

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
May 31, 2023
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.