Report from the HLH STUDY GROUP - December 2011
Study Group Members:
Maurizio Aricó, Itziar Astigarraga, Karin Beutel, Maarten Egeler, Lisa Filipovich, Jan-Inge Henter, AnnaCarin Horne, Eiichi Ishii, Gritta Janka, Stephan Ladisch, Kai Lehmberg, Ken McClain, Milen Minkov, Akira Morimoto, Vasanta Nanduri, Diego Rosso.
CLOSURE OF THE HLH-2004 STUDY
In line with a Study Group decision made in 2009, and in line with DSMB recommendations, the HLH Study Group has decided to close the HLH-2004 study for patient entry as of December 31, 2011.
Note that patients already enrolled on the study should continue treatment in line with the protocol and should be followed thoroughly in line with the protocol to allow full secondary endpoint data collection.
Jan-Inge Henter, MD, PhD
Study Group Chair
Download the Study Closure Memo
Important LCH III Study Update February 2008
While the LCH-III is closed to new patients in North America, the study remains open to collect patient follow-up forms from existing study participants. To view the Progress Report and/or the Scientific Review of the LCH-II Manuscript, follow this link.
Clinical Trials, Treatment Guidelines and References
For further information and instructions on how to obtain the trials, guidelines and references listed below, please follow this link.
LCH Evaluation and Treatment Guidelines
The LCH evaluation and treatment guidelines were approved in April 2009. These clinical guidelines have been developed by expert members of the Histiocyte Society and are intended to provide an overview of currently recommended treatment strategies for LCH.
The HLH-2004 protocol opened on January 1, 2004, and is designed for patients with inherited, familial hemophagocytic lymphohistiocytosis (FHLH) and nonfamilial hemophagocytic lymphohistiocytosis (HLH). This protocol is based on the HLH-94 protocol with minor therapeutic modifications.
This clinical trial was created in December 2005 and is now open for enrollment. It is an international phase II study evaluating the combination of Cladribine (2-CdA) and Cytarabine Cytosine-arabinoside (Ara-C) in LCH patients who fail to respond to front-line chemotherapy AND who have risk organ involvement.
This clinical trial was designed in 2006 with the primary objective of determining the overall and disease free survival at 1 and 3 years after reduced intensity hematopoietic cell transplantation (RI-HCT) in poor risk patients with Langerhans Cell Histiocytosis.