Tocilizumab and Hemophagocytic Lymphohistiocytosis (HLH)
Part of paid clinical trials in Philadelphia, Pennsylvania.
- Sponsor
- Children's Hospital of Philadelphia
- Study ID
- NCT02007239
- Phase
- PHASE2
- Status
- Withdrawn
Conditions
- Hemophagocytic Lymphohistiocytosis
Eligibility Criteria
- Sex
- ALL
- Age
- 3 Months - 25 Years
- Healthy Volunteers
- Not accepted
Interventions
- tocilizumab — DRUGsingle dose of tocilizumab (8mg/kg intravenously) within 24 hours of administration of standard immunochemotherapy.
Study Details
This study seeks to determine the efficacy of tocilizumab (TCZ) in patients with hemophagocytic lymphohistiocytosis (HLH) and high cytokine levels (proteins involved in inflammation) in an attempt to decrease the damage caused by these proteins; and secondarily to assess its safety and impact on disease activity.
Key Dates
- Start date
- Dec 31, 2013
- Status verified
- Mar 2022
- Primary completion
- May 31, 2021
- Completion
- May 31, 2021
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: treatmentsingle dose of tocilizumab (8mg/kg intravenously) within 24 hours of administration of standard immunochemotherapy.
Primary Outcome Measure
Reduction in serum interferon-gamma levels after tocilizumab (TCZ) administration [ Time Frame: baseline, 24 -36 hours, and 4-7 days after administration of TCZ ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | - |
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