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Data from a clinical trial led by investigators at St. Jude Children’s Research Hospital with the investigational agent clofarabine were presented June 5 at the 40th annual meeting of the American Society of Clinical Oncology. These data revealed that children with refractory or relapsed acute lymphoblastic leukemia (ALL), the most common cancer in children, had a 31 percent overall response rate to clofarabine. In addition, a number of children with refractory or relapsed acute myeloid leukemia (AML) treated with clofarabine went on to receive bone marrow or stem cell transplants.
“Children who are resistant to standard therapy have a very poor prognosis, with a life expectancy of six to eight weeks,” said lead investigator Sima Jeha, MD, Director, Developmental Therapeutics, Division of Leukemia/Lymphoma, St. Jude Children’s Research Hospital. “In the Phase II clofarabine studies, a number of patients experienced a reduction of disease in their blood, allowing them to undergo a bone marrow transplant which is the best chance for long-term survival.”
A New Drug Application (NDA) for clofarabine has been submitted to the U.S. Food and Drug Administration (FDA) for the treatment of pediatric refractory or relapsed acute leukemia. Refractory or relapsed leukemia indicates a patient’s disease has returned after initial treatment or has been unresponsive to other therapies. Clofarabine was granted a fast-track designation by the FDA, which is indicative of a treatment that is intended to treat an unmet medical need.
Interim data from the Phase II pivotal study showed that the ALL group (n=49) achieved a 31 percent overall response rate, with seven complete remissions (CR), three complete marrow remissions in the absence of platelet recovery (CRp) and five partial remissions (PR). The AML group (n=35) achieved a 26 percent response rate, with one CRp and eight PRs. An interim monitoring of 35 AML patients showed that 17 percent of the responders, or 6 patients, went on to receive post-clofarabine transplants, which provides an opportunity to prolong life for these patients.
“Certain patients in these trials had failed as many as six prior regimens,” said Dr. Jeha. “Clofarabine provided patients with new hope, allowing some to experience durable remission.”
In 2004, an estimated 3,200 new cases of pediatric leukemia will be diagnosed. If granted FDA approval, clofarabine will be the first, new pediatric leukemia drug to be made available exclusively to children in more than a decade.
St. Jude Children's Research Hospital
St. Jude Children's Research Hospital is internationally recognized for its pioneering work in finding cures and saving children with cancer and other catastrophic diseases. Founded by late entertainer Danny Thomas and based in Memphis, Tennessee, St. Jude freely shares its discoveries with scientific and medical communities around the world. No family ever pays for treatments not covered by insurance, and families without insurance are never asked to pay. St. Jude is financially supported by ALSAC, its fundraising organization.