Clolar (TM) now adopted by Europe as a medicine for ALL - Acute Lymphocytic Leukemia and particularly for children 1 to 21 years - with relapsed ALL. Phase II study confirmed earlier positive results with this agent in children with ALL. Article posted July 12, 2006
December 30, 2004: Source: Wall Street Journal and DOWnewsThe European Commission has followed the FDA officially approved as a drug clofarabine against Lymnfatische ALL = Acute leukemia in patients who had a recurrence. Here I found a recent phase II study confirms the good results of clorafabine. Previously, the FDA gave approval based on just a phase I / II study, but in practice clorafabine to work well. In this abstract also read that children who received a recidef after previous treatment with a treatment clorafabine still eligible for a bone marrow transplant.
J Clin Oncol. 2006 in April 1920, 24 (12) :1917-23. Phase II study of clofarabine in refractory or relapsed pediatric patiënten with acute lymphoblastic leukemia. Jeha S, Gaynon PS, Razzouk BI, Franklin J, Kadota R, Shen V, Luchtman-Jones L, Rytting M, Bomgar LR, Rheingold S, Ritchey K, Albano E, Arceci RJ, Goldman S, Griffin T, Altman A, Gordon B, Steinherz L, Weitman S, Steinherz P. Department of Hematology-Oncology, St Jude Children's Research Hospital, Memphis, TN 38105, USA. sima.jeha @ stjude.org PURPOSE: To Evaluate the efficacy and safety of clofarabine, a novel deoxyadenosine analog, in refractory or relapsed pediatric patiënten with acute lymphoblastic leukemia (ALL). PATIENT AND METHODS: In a phase II, open-label, multicenter study, 61 with refractory or relapsed pediatric ALL patiënten Received clofarabine 52 mg/m2 intravenously over 2 hours daily for 5 days, everytime 2 to 6 weeks. The median age was 12 years (range, 1 to 20 years), and the median number of prior regimens was three (range, two to six regimens). RESULTS: The response rate was 30%, texture or seven complete remission (CR), five CRs without platelet recovery (CRP), and six partial remission. Remission Were durable enough to allow patiënten to proceed to vote hematopoietic cell transplantation (HSCT) after clofarabine. Median CR duration in patient who did not receive HSCT was 6 weeks, with four patiënten Maintaining CR or CRp for 8 weeks or more (8 +, 12, 37 +, and 48 weeks) on clofarabine therapy alone. The Most common adverse events or grade> or = 3 Were febrile neutropenia, anorexia, hypotension, and nausea. CONCLUSION: Clofarabine is active as a single agent in pediatric relapsed or refractory multiple patiënten with ALL. The toxicity profile was as expected in this Heavily pretreated patient population. Studies exploring rational combinations of clofarabine with Other agents are ongoing in an effort to maximize clinical benefit. Publication Types: Clinical Trial, Phase II Multicenter Study PMID: 16622268 [PubMed - indexed for MEDLINE]




