Prospective Validation of the OHI Index

NCT05882175 | Recruiting

• 1 other identifier: 0321-19-MMC
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

HLH; Hemophagocytic Lymphohistiocytoses; Hemophagocytic Syndrome; Hematologic Malignancy; Hematologic Neoplasms

Outcome Measures

Primary Outcomes (1)

• To assess 365 days mortality of OHI+ and OHI- patients

  The investigators will use Kaplan-Meier curves to compare survival between OHI+ and OHI- patients

  Mortality rate one year from OHI assessment

Secondary Outcomes (1)

• To determine the incidence of OHI+ patients in our cohort

  The investigators will assess the incidence after three years of enrollment

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and females with new diagnosis/transformation/reactivation of hematologic malignancies

You may qualify if:

• Patients with hematologic malignancies
• At least 18 years old

You may not qualify if:

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

Sponsors & Collaborators

• Meir Medical Center: lead
• Children's Hospital Medical Center, Cincinnati: collaborator
• Rabin Medical Center: collaborator
• Sheba Medical Center: collaborator
• Schneider Children's Medical Center, Israel: collaborator

Study Sites (2)

Meir Medical Center

Kfar Saba, 4428164, Israel

RECRUITING

Rabin Medical Center

Petah Tikva, 49100, Israel

RECRUITING

Related 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.

  PMID: 34780598 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples and peripheral blood mononuclear cells

MeSH Terms

Conditions

Lymphohistiocytosis, Hemophagocytic; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms; Hematologic Diseases

Study Officials

• Adi Zoref-Lorenz

  Meir Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adi Zoref Lorenz, MD

CONTACT

513 6525610; adi.zoref.lorenz@cchmc.org

Noa Rabinowicz, PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: May 31, 2023
• Study Start: March 3, 2021
• Primary Completion (Estimated): March 3, 2030
• Study Completion (Estimated): March 3, 2030
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)