NEW ORLEANS (Reuters Health) - Clofarabine, a next-generation nucleoside analogue, is highly active in children with relapsed or refractory acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML), including those who have failed prior nucleoside therapies, according to interim data from phase II studies presented Saturday at the 40th annual meeting of the American Society of Clinical Oncology.
“In the last 10 years we have really reached a plateau in treating children with unresponsive or relapsed acute leukemias,” Dr. Sima Jeha from St. Jude Children’s Research Hospital, Memphis, Tennessee, told Reuters Health. “Clofarabine offers hope to these children, producing durable remissions in some and allowing some to proceed to bone marrow transplant, which offers the best chance for long-term survival.”
It is also “very significant,” she added, that clofarabine has efficacy in both ALL and AML, explaining that most drugs in the past have worked in only one category.”
Interim results in 49 children with ALL show a 31% overall response rate, with seven complete remissions, three complete marrow remissions in the absence of platelet recovery (CRp), and five partial remissions.
In 35 children with AML, the overall response rate is 26% to date, with one CRp and eight partial remissions. Six children proceeded to bone marrow transplantation. Clofarabine is administered at intravenously over 5 consecutive days and cycles are repeated every 2 to 6 weeks based on response and toxicity.
Most drug-related side effects are transient and include fever, nausea/vomiting, headache, skin rash, hand-foot syndrome, elevated liver enzymes and bilirubin, and infusion-related flushing and anxiety.
Ilex Oncology Inc. and partner Bioenvision Inc.'s NDA for clofarabine for the treatment of pediatric refractory or relapsed acute leukemia has been granted fast-track status by the U.S. Food and Drug Administration. (see Reuters Health Industry Briefing report June 3, 2004).
MeSH Headings:Clinical Trials: Congresses: Health Care Economics and Organizations: Environment and Public Health: Epidemiologic Methods: Evaluation Studies: Health: Health Occupations: Health Services Administration: Leukemia, Myelocytic, Acute: Medicine: Investigative Techniques: Organizations: Population Characteristics: Preventive Medicine: Public Health: Quality of Health Care: Specialties, Medical: Leukemia, Lymphocytic, Acute: Leukemia, Nonlymphocytic, Acute: Drugs, Investigational: Epidemiologic Study Characteristics: Clinical Trials, Phase II: Health Care Quality, Access, and Evaluation: Health Care Evaluation Mechanisms: Analytical, Diagnostic and Therapeutic Techniques and Equipment: Biological Sciences: Health CareCopyright © 2002 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.