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NCT01104025 · ClinicalTrials.gov registry record · Phase 2

Hybrid Immunotherapy for Hemophagocytic LymphoHistiocytosis

A Phase 2 study, sponsored by Children's Hospital Medical Center, Cincinnati.

Completed
Registry status
Phase 2
Development phase
31
Enrollment target

NCT01104025 is a Phase 2 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 31 participants.

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The verdict

NCT01104025, a Phase 2 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.

COMPLETED
Registry status
Phase 2
Development phase
31 participants
Enrollment target

Study Summary

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.

Interventions

  • DRUG Etoposide
  • DRUG Dexamethasone
  • DRUG Methotrexate
  • DRUG hydrocortisone
  • DRUG ATG, rabbit

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2010-04
Est. Completion 2016-04
Phase Phase 2

What the Registry Record Tells You About NCT01104025

The ClinicalTrials.gov registry entry for NCT01104025 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Etoposide is the first listed.

NCT01104025 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01104025 about?

NCT01104025 is a clinical study titled "Hybrid Immunotherapy for Hemophagocytic LymphoHistiocytosis". 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 seco...

What is the current status of trial NCT01104025?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2010-04. Estimated completion is 2016-04.

What interventions are being tested in trial NCT01104025?

The interventions under investigation include: Etoposide (DRUG), Dexamethasone (DRUG), Methotrexate (DRUG), hydrocortisone (DRUG), ATG, rabbit (DRUG).

Who is sponsoring clinical trial NCT01104025?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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