Clinical trial · Observational
Prospective Validation of the OHI Index
A Prospective Study to Validate the Prognostic Power of the Optimized HLH Inflammatory (OHI) Index
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Hematologic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Hemophagocytic Lymphohistiocytoses | — | UNRESOLVED | — |
| Hemophagocytic Syndrome | — | UNRESOLVED | — |
| HLH | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- OHI+ patients
- description
- Adult patients with hematologic malignancies that have sCD25\>3,900 U/mL and ferritin \>1,000 ng/mL
- label
- OHI- patients
- description
- Adult patients with hematologic malignancies, with sCD25\>3,900 U/mL and/or ferritin \< 1,000 ng/mL
Primary outcomes (1)
- measure
- To assess 365 days mortality of OHI+ and OHI- patients
- timeFrame
- Mortality rate one year from OHI assessment
- description
- The investigators will use Kaplan-Meier curves to compare survival between OHI+ and OHI- patients
Secondary outcomes (1)
- measure
- To determine the incidence of OHI+ patients in our cohort
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with hematologic malignancies * At least 18 years old Exclusion Criteria: * Prior recent treatment (chemotherapy/ other cytoreductive therapies in the last month)
References
Publications (1)
- BACKGROUNDZoref-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