A Prospective Study to Validate the Prognostic Power of the Optimized HLH Inflammatory (OHI) Index
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Meir Medical Center
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- To assess 365 days mortality of OHI+ and OHI- patients
Study Overview
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.
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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)
Outcomes
Primary Outcomes
To assess 365 days mortality of OHI+ and OHI- patients
Time Frame: Mortality rate one year from OHI assessment
The investigators will use Kaplan-Meier curves to compare survival between OHI+ and OHI- patients
Secondary Outcomes
- To determine the incidence of OHI+ patients in our cohort(The investigators will assess the incidence after three years of enrollment)