Prospective Validation of the OHI Index

Recruiting

• Conditions: HLH; Hemophagocytic Lymphohistiocytoses; Hematologic Malignancy; Hematologic Neoplasms; Hemophagocytic Syndrome

• Registration Number: NCT05882175
• Lead Sponsor: Meir Medical Center

Brief Summary

Hemophagocytic lymphohistiocytosis (HLH) associated with hematologic malignancies (HM-HLH) is a syndrome with an abysmal prognosis (10-30% 5 years overall survival). We 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. We will follow the patients until the end of the study, report their survival at one year and examine their prognosis.

Study Timeline

• Study First Submitted: 2021-01-19
• Study Start: 2021-03-03
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-21
• Last Update Submitted: 2023-05-21
• Study First Posted: 2023-05-31
• Last Update Posted: 2023-05-31
• Primary Completion: 2025-03-03
• Study Completion: 2026-03-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patients with hematologic malignancies
• At least 18 years old

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess 365 days mortality of OHI+ and OHI- patients	Mortality rate one year from OHI assessment	We will use Kaplan-Meier curves to compare survival between OHI+ and OHI- patients

Secondary Outcome Measures

Name	Time	Method
To determine the incidence of OHI+ patients in our cohort	We will assess the incidence after three years of enrollment	We will assess the incidence of OHI+ within our cohort (OHI+/total patients enrolled)

Trial Locations

Locations (2)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel

Rabin Medical Center; 🇮🇱 Petach Tikva, Israel