International Consortium on Acute Promyelocytic Leukemia Helps First Patients in Brazil, Mexico, and Jordan

A young woman from Pueblo, Mexico, with acute promyelocytic leukemia (APL) became one of the first patients benefiting from the International Consortium on APL (IC-APL). She was provided medical care according to the IC-APL protocol, achieved remission without bleeding complications, and enjoys a high probability of being cured of her leukemia.

With current therapy, including all-trans retinoic acid, 70-80 percent of patients with APL are alive and free of disease at five years. In certain geographic areas, such as Latin America, the incidence of APL is greatly increased, with APL accounting for up to 20-25 percent of all acute myelogenous leukemia cases. In these same developing countries, however, a lack of infrastructure and funding has inhibited the adoption of current cutting-edge therapy.

In December of 2004 at a workshop hosted by ASH’s International Members Committee (IMC), a group of international experts on APL and investigators from Brazil, Mexico, and Jordan met to initiate a concerted effort designed to introduce and foster clinical and laboratory procedures that represent standards of care for the treatment of APL. For capacity-building purposes, standard therapy was implemented modeling a clinical trial. This will allow the participating countries to later undertake network-based clinical studies on patients with APL or other hematologic diseases.

Within only 18 months, the IC-APL protocol was written and approved by the respective national and local ethics committees, allowing the first patients to be enrolled. The IC-APL Subcommittee on Laboratory and Diagnostic Guidelines specified general recommendations and protocols for sample collection, banking, genetic diagnosis, and coagulation studies. Bylaws outlining the concerted efforts of this unique consortium were also finalized.

The St. Jude Children’s Hospital International Outreach Program, under the direction of Dr. Raul Ribeiro, provides active support to the IC-APL with respect to Web registration and data management. In April 2006, a Brazilian colleague, Dr. Rafael Jacomo, visited St. Jude Children’s Research Hospital to learn all aspects of patient registration and data management. Dr. Jacomo has created a data manager training manual and started coordinating and facilitating training for all other data managers.

Under the coordination of Drs. Eduardo Rego (Brazil), Guillermo Ruiz-Arguelles (Mexico), and Mohammed Milhem (Jordan), seven centers in Brazil, five centers in Mexico, and two institutions in Jordan are currently involved in the initiative.

Work within the different groups of IC-APL is extremely active and lively. Using the Web conferencing technology of Cure4Kids, an established part of the St. Jude International Outreach Program, live meetings amongst members of the different groups have been initiated. Local investigators discuss their patients weekly, while data managers, IC-APL subcommittees, and the Steering Committee meet on separate schedules.

In June of 2006, the Veronesi Foundation of Milano, Italy, pledged a two-year grant of 100,000 euros to the IC-APL. This generous donation is greatly appreciated by all who have worked so hard on this important project. Financial support from public and private organizations will be essential for fostering research in hematology in countries with limited resources.

By modeling all aspects of clinical trials through implementing the standard-of-care protocol, we expect the participating countries to be poised to undertake network-based clinical studies at the end of an initial period. The IMC is proud of the progress of the IC-APL to date and believes that models like the IC-APL will stimulate clinical collaboration and hematologic research around the world.