Grant Awarded in 2008

Histiocyte Society Clinical Trials Database System
LCH-IV Treatment Protocol Study


Project Administrators
Histiocyte Society Executive Board
LCH Study Reference Center- Vienna, Austria

Date of Award
December 2008

Amount of Award
$76,248

Twelve Month Report
The HAA is pleased to provide the following update regarding the status of the LCH-IV Treatment Protocol Study.

In designing the study, the Histiocyte Society Executive Board and study co-chairs Drs. Carlos Rodriguez-Galindo and Milen Minkov took a more ambitious approach than those used in previous histiocytosis clinical trials. Whereas past trials have been focused on evaluating the effectiveness of standard front line treatment methods, the LCH-IV Study will incorporate multiple salvage alternatives in addition to the front line treatment. This approach of combining multiple treatment modalities and research objectives in one protocol adds significant complexity to the study design; few studies in medical research have used this approach, making its introduction an important milestone in the field of histiocytosis research.

In this highly sophisticated study, patients with newly diagnosed LCH will initially be enrolled on the front line treatment protocol. Patients who experience reactivations of their disease will then be enrolled on the appropriate salvage treatment protocols included within the study. These salvage options, designed as independent treatment protocols, include low-risk, high-risk, and bone marrow transplant. As well, the study’s investigators have integrated an analysis of the long term effects of LCH and its treatment experienced by patients into the entire trial. The primary focus of this research will be to understand the risk factors for the development of neurodegeneration and neuroendocrine deficits, devise early diagnostic tools, and provide effective treatments.

Because of its comprehensive design, this study will allow researchers to evaluate the effectiveness of five protocols for the treatment of LCH and examine a variety of important questions related to the study’s findings. As the field of medical research is currently subject to increasingly stringent regulatory requirements, the study’s investigators intend for its comprehensive structure to result in the participation of a higher number of institutions, an increase in the amount and quality of data generated, and the study’s overall success. While its launch has been delayed slightly due to the complexity and originality of its design, the study’s primary investigators intend for it to be finalized and opened in advance of the Histiocyte Society Annual Meeting, which will take place in Boston, Massachusetts in October 2010.

The study’s investigators commend the staff of the Children's Cancer Research Institute in Austria, Vienna, led by Dr. Milen Minkov, for their extraordinary efforts in finalizing the study’s document and database for its impending launch. The final version of the protocol will be circulated for review to participating researchers within the next two months.

The study’s authors express their appreciation to the HAA for supporting this important initiative.
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