By Nancy Berliner, MD

2007-09-01

Dr. Berliner is Chief of Hematology at Brigham and Women’s Hospital. She is also Vice President of ASH.

Members of the International Consortium on Acute Promyelocytic Leukemia (IC-APL) gathered in Vienna prior to the 2007 European Hematology Association (EHA) meeting to present an update on their progress. Initiated under the ASH umbrella in December 2004, the IC-APL was created to facilitate interactions between clinicians and researchers in developing countries, with the long-term goals of improving clinical care and creating the infrastructure for ongoing clinical trials and translational research in APL. APL was chosen as a model disease because of its prevalence in Latin America and the rapid progress that is being made in understanding its pathogenesis and in optimizing its therapy.

Representatives from the programs in Brazil, Mexico, and Uruguay reported progress at the meeting. Treatment has started at two centers under the auspices of clinical guidelines outlining standard of APL care developed by a subcommittee of the IC-APL. Brazil reported treatment results on 23 patients, and Mexico reported on their first 10 patients. Uruguay, who joined the project in December 2006, reported progress toward a national IRB approval to allow the accrual to start at several health centers.

Both the clinical results and the progress toward an interactive infrastructure supporting future research were impressive. Clinical outcomes rival those in large clinical trials in developed countries, with a complete remission (CR) rate of 90 percent, with most patients in CR having evidence of molecular remission. (It is important to note that prior to starting treatment, all patients are diagnosed through sample collection to national reference laboratories where genetic studies for identifying the disease-specific markers are carried out according to well-established cytogenetic and molecular tests.)

Perhaps more impressive, the IC-APL has given rise to unprecedented cooperation between disparate centers in the respective countries, integrated through the active collaboration of St. Jude Children’s Research Hospital.

All centers are actively using the Pediatric Oncology Network Database (POND) and the Cure4Kids programs for data management. Participants within each country and between countries have frequent teleconferences to troubleshoot problems and facilitate collaboration. The data manager from Uruguay has traveled to Sao Paulo, Brazil, to be trained in these programs. Although supported partly by ASH and partly by a grant from the Veronesi Foundation, much of the activity is being funded from local and national sources within the participating countries.

Discussion of future efforts focused on clinical modifications addressing the high incidence of ATRA syndrome and practical concerns about sample acquisition for central testing of coagulation parameters, as well as potential collaborative clinical-translational trials being initiated independently by the various participants. In addition, several other countries are under consideration for inclusion in the IC-APL, and proposals from these countries will be discussed further at the December meeting prior to the ASH annual meeting.

The data presented at the meeting engendered great enthusiasm and energy. All of the leaders of the individual sites reported that the association with ASH in these activities has jumpstarted the high level of collaboration and interaction inherent in the IC-APL, and they are eager to continue to move things forward. The success of this venture is one in which the Society should take considerable pride: the IC-APL provides a model for promoting the excellence of hematology care and extending research.

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