Prospective Validation of the OHI Index (HLH)

Clalit Health Services

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT05882175

0321-19-MMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with hematologic malignancies
• At least 18 years old

Exclusion criteria

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

Trial design

300 participants in 2 patient groups

OHI+ patients

Description:

Adult patients with hematologic malignancies that have sCD25\>3,900 U/mL and ferritin \>1,000 ng/mL

OHI- patients

Description:

Adult patients with hematologic malignancies, with sCD25\>3,900 U/mL and/or ferritin \< 1,000 ng/mL