HLH-2004. Hemophagocytic Lymphohistiocytosis Study Group. Treatment Protocol of the Second International HLH Study 2004. - HLH-2004
Phase 1
- Conditions
- Hemophagocytic Lymphohistiocytosis (HLH), a life-threatening disease usually occurring in early childhood. HLH-2004 is an international treatment protocol which will be compared with the previous HLH-94 protocol. In HLH-2004 the cyclosporine treatment will be introduced at the start of therapy instead of after 8 weeks. Intrathecal therapy will consist of methotrexate in combination with prednisolone instead of methotrexate alone. Only a minority of the patients will receive intrathecal therapy.
- Registration Number
- EUCTR2005-003279-18-NO
- Lead Sponsor
- Barncancerforskningsenheten, Astrid Lindgrens Barnsjukhus
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
The diagnosis of HLH. All patients with this diagnosis will be offered the treatment protocol. All patients diagnosed with the disease for the first time are eligible for inclusion.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method