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| |  ASCO: Clofarabine Treatment Promising in Some Children With Relapsed Acute Leukaemias By Ed Susman CHICAGO, IL -- June 2, 2003 -- Children who have relapsed acute myelogenous leukaemia or acute lymphoblastic leukaemia appear to respond to treatment with the investigative drug clofarabine. This finding was reported at the 39th Annual Meeting of the American Society of Clinical Oncology. Doctors said that of 39 children with recurrent disease participating in an open-label phase II study -- some of whom responded despite having progressed on 6 different previous salvage regimens -- 4 complete remissions and 4 partial remissions were achieved. "That represents an overall response rate of 28%," said Sima Jeha, MD, associate professor of medicine at the University of Texas M.D. Anderson Cancer Center, Houston, United States, "which is encouraging among this group of very sick children." All of the children in the study were eligible for inclusion if they were ineligible for therapy of higher curative potential. All of them also had to have been in their second or subsequent relapse -- that is, they failed to achieve remission following 2 or more regimens. Twenty-five children in the study had acute lymphoblastic leukaemia; 14 had acute myelogenous leukaemia. One 18-year-old child with acute lymphoblastic leukaemia achieved complete remission and also spontaneously achieved platelet recovery after treatment. The other 3 children -- 1 with acute myelogenous leukaemia -- no longer had evidence of circulating blasts or extramedullary disease but required transplant for platelet recovery. In her poster presentation, Dr. Jeha said the children appeared to tolerate clofarabine at least as well as adults, and probably better. Clofarabine is a second-generation purine nucleoside analogue, which incorporates the active properties of fludarabine and cladribine. "Children have better kidneys and livers than adults," Dr. Jeha said, "and that allows us to give them higher doses of clofarabine than adults. The children can receive doses as high as 52 mg/m2 day for 5 days, while the dose limitation for adults is 40 mg/m2. The drug is administered intravenously. The most common grade 3 or 4 adverse events were nausea or vomiting in 6 patients; 10 cases of serious febrile neutropaenia were noted Dr. Jeha said that clofarabine was developed by scientists at M.D. Anderson, but is being commercially developed by ILEX Oncology of San Antonio, Texas. The study is continuing to accrue patients.
[Study title: A Phase II, Open-Label Study of Clofarabine in Pediatric Patients With Refractory or Relapsed Acute-Myelogenous or Lymphoblastic Leukaemia. Abstract 3251]
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