Hybrid Immunotherapy for Hemophagocytic LymphoHistiocytosis

Completed · Phase 2

Conditions studied: Hemophagocytic Lymphohistiocytosis

In brief

Despite good progress during the last decade, hemophagocytic lymphohistiocytosis (HLH) remains difficult to treat. Two different treatment regimens have been used successfully. The first one, a treatment regimen based on two drugs called etoposide and dexamethasone, has been used worldwide. The second regimen, based on two drugs called Anti-thymocyte globulin (ATG) and prednisone, has been used mostly at one hospital in Paris, for over 15 years. With either regimen, about three quarters of treated children survive the most difficult time, the first two months after diagnosis. These two different regimens appear to work somewhat differently, and we suspect that combining them may give better results than either regimen alone. We are conducting this clinical trial to test the combination of ATG, dexamethasone, and etoposide for the treatment of HLH. The purpose of this research study is to find out what effects (good and bad) this drug combination has on you and your HLH.

Key facts

Study ID

NCT01104025

Run by

Children's Hospital Medical Center, Cincinnati

People needed

31

Starts

2010-04-01

Expected to finish

2016-04-01

Last updated by the study team

2020-10-19

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• diagnosis of hemophagocytic lymphohistiocytosis
• Patients <18 years of age
• The patient must have active disease at the time of enrollment
• Patient's legal guardians must sign an Institutional Review Board approved consent form indicating their awareness of the investigational nature and the risks of this study.
• Eligible subjects must be enrolled with the protocol coordinating center

You may not qualify if…

• Recent treatment, within 3 months, with another therapeutic regimen for HLH
• Known active malignancy
• Known rheumatologic diagnosis which may be the underlying cause of HLH
• Pregnancy (as determined by serum or urine test) or active breast feeding
• Failure to provide signed informed consent

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• University of California, San Francisco Department of Pediatrics — San Francisco, California, United States
• Stanford University — Stanford, California, United States
• University of Colorado — Aurora, Colorado, United States
• Nemours — Wilmington, Delaware, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Nemours — Jacksonville, Florida, United States
• Florida All Children's Hospital — St. Petersburg, Florida, United States
• Tulane University Medical Center — New Orleans, Louisiana, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Texas Children's Cancer Center/Baylor College of Medicine — Houston, Texas, United States
• The Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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