Prospective Validation of the OHI Index
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: HLH, Hemophagocytic Lymphohistiocytoses, Hemophagocytic Syndrome, Hematologic Malignancy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Study to Validate the Prognostic Power of the Optimized HLH Inflammatory (OHI) Index
Overview
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.
Primary outcome measures
- To assess 365 days mortality of OHI+ and OHI- patients [Time frame: Mortality rate one year from OHI assessment]
Secondary outcome measures (1)
- To determine the incidence of OHI+ patients in our cohort [Time frame: The investigators will assess the incidence after three years of enrollment]
Eligibility criteria
Inclusion criteria
- Patients with hematologic malignancies
- At least 18 years old
Exclusion criteria
- Prior recent treatment (chemotherapy/ other cytoreductive therapies in the last month)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Israel · 2 centers
- Meir Medical Center — Kfar Saba
- Rabin Medical Center — Petah Tikva
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/bloo PMID 34780598
Identifiers
NCT: NCT05882175 · 0321-19-MMC