Prospective Validation of the OHI Index

Hematologic Malignancy Clinical Trial

— HLH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05882175
• Other study ID #: 0321-19-MMC
• Status: Recruiting
• Start date: March 3, 2021
• Est. completion date: March 3, 2026

Study information

• Verified date: May 2023
• Source: Meir Medical Center
• Contact: Adi Zoref Lorenz, MD
• Phone: 513 6525610
• Email: adi.zoref.lorenz[@]cchmc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 3, 2026
• Est. primary completion date: March 3, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with hematologic malignancies

• At least 18 years old

Exclusion Criteria:

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba
Israel	Rabin Medical Center	Petach Tikva

Sponsors (5)

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

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess 365 days mortality of OHI+ and OHI- patients	We will use Kaplan-Meier curves to compare survival between OHI+ and OHI- patients	Mortality rate one year from OHI assessment
Secondary	To determine the incidence of OHI+ patients in our cohort	We will assess the incidence of OHI+ within our cohort (OHI+/total patients enrolled)	We will assess the incidence after three years of enrollment