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Prospective Validation of the OHI Index

Study acronym: HLH
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Primary completion date: Mar 3, 2025 to Mar 3, 2030
    • Study completion date: Mar 3, 2026 to Mar 3, 2030
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 1 word
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05882175
Lead Sponsor Meir Medical Center
Collaborators: Children's Hospital Medical Center, Cincinnati, Rabin Medical Center, Sheba Medical Center, Schneider Children's Medical Center, Israel
Conditions
(from sponsor)		 HLH, Hemophagocytic Lymphohistiocytoses, Hemophagocytic Syndrome, Hematologic Malignancy, Hematologic Neoplasms
Related terms Hematologic Neoplasms, Lymphohistiocytosis, Hemophagocytic
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov