HLH: Prospective Validation of the OHI Index

Sponsor

Meir Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05882175

Collaborator

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

300

Enrollment

Locations

Anticipated Duration (Months)

150

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HLH Hemophagocytic Lymphohistiocytoses Hemophagocytic Syndrome Hematologic Malignancy Hematologic Neoplasms

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 Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 3, 2021

Anticipated Primary Completion Date :

Mar 3, 2025

Anticipated Study Completion Date :

Mar 3, 2026

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Meir Medical Center	Kfar Saba		Israel	4428164
2	Rabin Medical Center	Petach Tikva		Israel	49100

Sponsors and Collaborators

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

Investigators

Principal Investigator: Adi Zoref-Lorenz, Meir Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Zoref-Lorenz A, Murakami J, Hofstetter L, Iyer S, Alotaibi AS, Mohamed SF, Miller PG, Guber E, Weinstein S, Yacobovich J, Nikiforow S, Ebert BL, Lane A, Pasvolsky O, Raanani P, Nagler A, Berliner N, Daver N, Ellis M, Jordan MB. An improved index for diagnosis and mortality prediction in malignancy-associated hemophagocytic lymphohistiocytosis. Blood. 2022 Feb 17;139(7):1098-1110. doi: 10.1182/blood.2021012764.

Responsible Party:

Meir Medical Center

ClinicalTrials.gov Identifier:

NCT05882175

Other Study ID Numbers:

0321-19-MMC

First Posted:

May 31, 2023

Last Update Posted:

May 31, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hematologic Neoplasms

Lymphohistiocytosis, Hemophagocytic

Study Results

No Results Posted as of May 31, 2023