Categories:
Eligibility Overview:
- Diagnosis of a primary immunodeficiency predisposed to hemophagocytic lymphohistiocytosis
- Meets at least 4 of 8 diagnostic criteria for HLH as defined by the Histiocyte Society and is receiving HLH-directed therapy
- High suspicion of isolated Central Nervous System-HLH and is receiving HLH-directed therapy
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Brief Summary
This study is an international effort to collect clinical information on HLH patients. There will be two documentation time-points: the first will follow initial treatment and the second after one year. That data will be analyzed to determine the feasibility of a future randomized clinical trial to evaluate current HLH standard of care.
Primary Objective
- To collect data relevant for the assessment of feasibility and design of future interventional studies on HLH treatment
Eligibility Criteria
Inclusion criteria include:
- Diagnosis of a primary immunodeficiency predisposed to hemophagocytic lymphohistiocytosis (HLH)
- Meets at least 4 of the 8 diagnostic criteria for HLH and is receiving HLH-directed therapy (Steroids are sufficient.)
- High suspicion of isolated Central Nervous System-HLH and is receiving HLH-directed therapy
Exclusion Criteria include:
- Malignancy
- Rheumatological/autoinflammatory/autoimmune disease
- Metabolic disease
- Leishmania infection
Study Sites
St. Jude Children’s Research Hospital, Memphis, Tennessee
Collaborating sites outside the U.S. -
About this study
Hemophagocytic lymphohistiocytosis (HLH) is a rare, life-threatening condition that affects the body’s immune system. The disorder most often is seen in babies and young children. This study will collect information about HLH patients’ symptoms, laboratory values, treatment and outcomes.
Purpose of this clinical trial
The main goal of the study is to create an international database of HLH patient information. This information will help researchers develop clinical trials in the future on new HLH treatments.
Eligibility overview
- Diagnosis of a primary immunodeficiency predisposed to HLH
- Meets at least 4 of the 8 diagnostic criteria for HLH and is receiving HLH-directed therapy
- High suspicion of isolated Central Nervous System-HLH and is receiving HLH-directed therapy
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HSESID Quick View Sponsors St. Jude Children’s Research Hospital Trial Start Date May 2017 Estimated Enrollment 300 (30 at St. Jude) Study Type Observational Conditions Hemophagocytic lymphohistiocytosis Age All ages Principal investigator Melissa Hines, MD Study Sites St. Jude Children’s Research Hospital and collaborating sites in and outside the U.S. For a consultation or to discuss HSESID
St. Jude Physician/Patient Referral Office
1-888-226-4343
referralinfo@stjude.org
Contact
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org
The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.