Prospective Validation of the OHI Index

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05882175

Acronym

HLH

Enrollment

300

Registered

2023-05-31

Start date

2021-03-03

Completion date

2030-03-03

Last updated

2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematologic Malignancy, Hematologic Neoplasms, Hemophagocytic Lymphohistiocytoses, Hemophagocytic Syndrome, HLH

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Patients with hematologic malignancies * At least 18 years old

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
To determine the incidence of OHI+ patients in our cohort	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)

Countries

Israel

Contacts

Primary ContactAdi Zoref Lorenz, MD

adi.zoref.lorenz@cchmc.org513 6525610

Backup ContactNoa Rabinowicz, PhD

noa.rabinowicz@clalit.org.il+972-54-4864564

Outcome results