Langerhan's cells histiocytosis: Phase IV trials begin in India

2009
By Syed Akbar
Hyderabad: Hundreds of medical experts and researchers from across the country will collaborate with their counterparts in the USA to finalise a safe drug for a strange and rare disease that afflicts mainly children below two years of age.

Called the Langerhan's cells histiocytosis or simply LCH, the disease
mimics cancer but it is not carcinogenic in nature. It affects several
parts of the body and is a complicated disease, which for decades was
thought to be a form of cancer.

The Histiocyte Society of the United States has sought the help of
medical colleges, hospitals and experts for a network to carryout the
LCH trial in the Indian sub-continent. The trials will begin later this
month. The reference centre will be Vienna, Austria. Drugs that have
been developed to fight this rare disease have already undergone three
phases and the participation of Indians in the fourth phase trials
assumes significance since there are several LCH patients in the sub-
continent.

According to Dr T Vasantha, who is coordinating the trials in the
country, histiocytosis is a very difficult disease to explain and
understand. The disease affects bones, pituitary gland, eyes, liver,
spleen, bone marrow and skin.

This is a randomised trial and randomisation takes place at Indian
Council of Medical Research. The All-India Institute of Medical
Sciences is coordinating the study. Treatment for this rare disease has
been approved and is being marketed. The present study is to evaluate
side effects that were not apparent in the phase III trial. Thousands of
people will be involved in the present phase.

"Medical colleges and hospitals will send samples to AIIMS which in
turn will forward them to the Histiocyte Society," Dr Vasantha said.